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Journal articles on the topic 'Dossier Preparation'
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Snegireva, I. I., E. O. Zhuravleva, and N. Yu Velts. "Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier." Safety and Risk of Pharmacotherapy 8, no. 4 (2020): 191–97. http://dx.doi.org/10.30895/2312-7821-2020-8-4-191-197.
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The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registration dossier, for compliance with the EAEU GVP requirements for submission, content, and completeness of all sections of the document. They identified the most common types of errors in PSMF preparation and analysed conditions when a PSMF is required or, alternatively, when a brief summary of the pharmacovigilance system of the marketing authorisation holder will suffice. The paper summarises specific aspects of incorporating pharmacovigilance system documents in regulatory submissions, as well as aspects of presenting pharmacovigilance system data when bringing the registration dossier in line with the EAEU requirements. This information may be useful for marketing authorisation holders who are the main stakeholders in the medicine authorisation process and who are directly involved in the pharmacovigilance system management during the authorisation and post-authorisation stages of the drug life-cycle.
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Godiyal, Shrikant. "Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 51–61. http://dx.doi.org/10.22270/ijdra.v7i2.318.
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To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.
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HAERTEL, LORRAINE C. "PREPARING THE ACADEMIC DOSSIER." Nurse Educator 14, no. 1 (1989): 31–33. http://dx.doi.org/10.1097/00006223-198901000-00016.
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Yadav, Sudhir. "Building regulatory capabilities for pharmaceutical firms' internationalization." International Journal of Pharmaceutical and Healthcare Marketing 7, no. 1 (2013): 58–74. http://dx.doi.org/10.1108/1750612131131.
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PurposeThe internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.Design/methodology/approachThe research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulatory capabilities.FindingsTo manage regulatory requirements firms need knowledge related to plant approval and product registration. Firms have to submit dossiers to the respective country's regulatory authority to get plant approval and product registration. They can simultaneously apply for both to save time to enter the target market. The requirements for each market are unique in terms of format and contents for dossier preparation. Dossier preparation needs data from various departments which calls for good coordination among various functional areas, i.e. production, QA and QC, R&D, purchasing, etc. If the firm has operations in multiple markets and offers multiple products in a single market the regulatory function is separately organized for less regulated, semi‐regulated and regulated markets.Practical implicationsPharmaceutical firms targeting international markets can get insight into the regulatory requirements and the process to be adopted to build regulatory requirements.Originality/valueThe paper shows that firms use a systematic process to build capabilities for managing regulations. The paper also offers a process model for firms to build regulatory capabilities for internationalization.
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Gupta, Rajkumar M. "PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)." International Journal of Drug Regulatory Affairs 3, no. 2 (2018): 17–21. http://dx.doi.org/10.22270/ijdra.v3i2.164.
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ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the part II is most important. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients.
 The major stress in this part is on formulation, manufacturing, stability and process validation. The information required under this part is suitably detailed in this article.
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SO, Nasare. "Procedures for Dossier Preparation and their Marketing Authorisation in Zimbabwe Country for Complementary Drug." Pharmaceutical Drug Regulatory Affairs Journal 6, no. 1 (2023): 1–4. http://dx.doi.org/10.23880/pdraj-16000141.
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The Medicines Control Authority of Zimbabwe (MCAZ) is the authority to regulate from the Ministry of Health. It is established through an Act of Parliament which gives these bodies the `power to regulate the quality and sale of Complementary medicines. The objectives of this study were to evaluate the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate overall performance from 2017 to 2019, identify best practices in review, evaluate the quality of decision-making processes and identify challenges and opportunities for improvement. Complementary medicine has always been at the heart of most Zimbabweans. That most of the drug is located close to the African community makes it very attractive, user-friendly, cost-effective and flexible in adapting to the dynamics of modern societal trends. The aim is to understand the need for professionalization of complementary medicine. The guidelines were studied from the website. We studied the guidelines to prepare a checklist and dossier preparation to submit to the authority of Zimbabwe.
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Raysing, Swati, Pankaj Nerkar, Siddhesh Sanghavi, Shewta Jogdand, and Atul Patil. "Comparative study of Regulatory requirement for preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada." International Journal of Drug Regulatory Affairs 11, no. 3 (2023): 62–67. http://dx.doi.org/10.22270/ijdra.v11i3.619.
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The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.
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J., Neelima K. Anie Vijetha A. Srivani P. Sravanthi. "REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2018): 4790–97. https://doi.org/10.5281/zenodo.1134382.
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The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. This guideline merely demonstrates an appropriate write-up format for acquired data. Throughout the ACTD, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. ICH‐ECTD is an internationally driven standard designed to reduce cost in the administration, assessment and archiving of applications for marketing authorization of medicinal products for human use, to reduce the use of paper and streamline the assessment process making the system more efficient.
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Chris Chang, J. M. "Paper Affairs: Discipline by the Dossier in a Mao-Era Work Unit." Administory 4, no. 1 (2019): 125–40. http://dx.doi.org/10.2478/adhi-2019-0008.
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AbstractThis article examines how dossier files informed the handling of personnel misconduct in Chinese work units using an investigation of adultery as a case study. By the Cultural Revolution (1966–1976), the disciplinary functions of the dossier system were an embedded feature of social control in the work unit, partially shifting responsibility for policing petty crime to local administrators. In this case, the revelation of an extramarital relationship in 1974 set off a bureaucratic operation to produce documentary proof of the alleged wrongdoing. The thick case file prepared by the work unit investigators grew to include a tranche of seized love letters, a series of dubious confessions, and detailed bureaucratic reports. The preparation of evidence bound for the dossier demonstrates the extent to which the demands of documentation formed a distinct end of the investigative process, while revealing how people and paper were mobilized to deal with a minor administrative affair.
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Burri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341324.
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<em>Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures.</em> <strong>Keywords:</strong><em> CTD, Generic drug, CDSCO, Bioequivalence, ANDS.</em>
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Burri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341334.
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<em>Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures.</em> <strong>Keywords:</strong><em> CTD, Generic drug, CDSCO, Bioequivalence, ANDS</em>
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Rutanshi, Patel*1 Gargi Patel2 Dr. Maitreyi N. Zaveri3 Zuki Patel4. "Strategic Insights into Drug Regulatory Affairs: Dossier Preparation, Marketing Authorization, Variation and Safety Monitoring in Tanzania." International Journal of Scientific Research and Technology 3, no. 4 (2025): 430–36. https://doi.org/10.5281/zenodo.15132665.
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Pharmaceutical regulatory affairs play a crucial role in ensuring drug quality, safety, and efficacy. This thesis, titled "Strategic Insights into Drug Regulatory Affairs: Dossier Preparation, Marketing Authorization, Variation, and Safety Monitoring in Tanzania", explores the regulatory landscape of the Tanzania Medicines and Medical Devices Authority (TMDA). It provides a comprehensive analysis of dossier preparation for drug registration, the marketing authorization process, post-approval variation management, and pharmacovigilance requirements in Tanzania.The study examines TMDA’s regulatory framework, highlighting key requirements for medicinal product registration, renewal, and compliance with national and international guidelines. Through an in-depth review of variation classifications, submission processes, and regulatory timelines, this research identifies challenges encountered by pharmaceutical companies in maintaining compliance. Additionally, it emphasizes the importance of pharmacovigilance in post-market drug safety monitoring, outlining adverse event reporting mechanisms and risk management strategies.Findings from this study offer valuable insights for pharmaceutical professionals, regulatory authorities, and stakeholders seeking to navigate the Tanzanian regulatory environment efficiently.
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Kürschner, N., and S. Schmitter. "Epidemiology for Oncological Drugs Regarding the Benefit Dossier Preparation in Germany." Value in Health 16, no. 7 (2013): A429. http://dx.doi.org/10.1016/j.jval.2013.08.613.
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Schmitter, S., M. Hartge, G. Zibell, and J. Schiffner-Rohe. "PHP158 Cross-Funtional Challenges in the Preparation of a Benefit Dossier." Value in Health 15, no. 7 (2012): A317. http://dx.doi.org/10.1016/j.jval.2012.08.700.
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Anand, Kumar Dohare, and Abuzaid Mohammad. "Forecasting Stock Prices through Time Series, Econometric, Machine Learning, and Deep Learning Models." International Journal of Engineering and Management Research 14, no. 1 (2024): 77–85. https://doi.org/10.5281/zenodo.10688767.
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Over an comprehensive ending, scientist have loyal solid efforts to plan a strong and exact predicting foundation for guessing stock prices. Academic discourse emphasizes that intricately devised and refined predicting models occupy the competency to carefully and dependably expect future stock principles. This case introduces a various array of models, including methods to a degree period succession reasoning, econometrics, and miscellaneous knowledge-based approaches tailor-made for stock price guess. Analyzing dossier connecting from January 2004 to December 2019 for famous enterprises to a degree Sun Pharma Group, ICICI Bank, and Infosys Technologies, the models suffered rigorous preparation and estimate to judge their influence across various labors. This research engages a unique mixture of methodologies, containing an individual occasion order models , an econometric approach (ARIMA model), and a pair of machine intelligence model like MARS and Random Forest. Additionally, the study integrates two deep knowledge- located models, particularly the plain RNN and LSTM. This diverse array of models aims to supply a inclusive study of stock price activities vague areas. The study results emphasize the preeminence of Multivariate Adaptive Regression Splines (MARS) as the most able machine intelligence model, Short-term memory (LSTM) has emerged as a deep learning model. Importantly, MARS usually illustrates superior influence in the specific domain of transactions guessing across the Information Technology (resorting to Infosys dossier), Banking (illustration upon ICICI dossier), and Health (depending SUN PHARMA dossier) sectors.
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Engalycheva, G. N., and R. D. Syubaev. "Preparation of a Nonclinical Overview Based on Scientific Literature." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 11, no. 4 (2021): 263–72. http://dx.doi.org/10.30895/1991-2919-2021-11-4-263-272.
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Current requirements for the registration dossier include submission of a preclinical (nonclinical) overview, including scientific literature data on preclinical studies and actual preclinical data on the medicinal product. For some groups of medicines, scientific literature data may be used instead of actual preclinical data, which may be redundant. One of the important functions of the scientific literature review is the analysis of updated preclinical information on the medicinal product, which reflects the product’s characteristics, supports conclusions on its efficacy or safety, and may affect the results of the benefit/risk assessment. The aim of the study was to determine the optimal format for presenting scientific literature data in a nonclinical overview that would reflect the methodological aspects of preclinical pharmacology and toxicology studies of medicines. The authors analysed the regulations of the Russian Federation and the Eurasian Economic Union containing requirements for the scientific literature review submitted instead of actual preclinical data as part of the registration dossier for a medicinal product. The authors also considered potential difficulties in preparing a nonclinical overview based on scientific literature. In order to systematise scientific literature data, it is recommended to provide pharmacodynamic, pharmacokinetic, and toxicological data using a format consistent with the common technical document. The proposed recommendations help to harmonise the process of preparation and design of a nonclinical overview which should contain data and facts enabling a reasoned assessment of the benefit/risk ratio. The standardised format of literature data presentation will help the developer prepare an adequate nonclinical overview and will speed up assessment of clinical trial or marketing authorisation applications.
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Todić, Maida. "Dossier for marketing authorization in the European union." Bosnian Journal of Basic Medical Sciences 3, no. 1 (2003): 56–60. http://dx.doi.org/10.17305/bjbms.2003.3572.
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Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions.The presentation and content of the dossier in the European Union has been redefined. The “old” EU format will be replaced with the Common Technical Document (EU CTD format) agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.
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Todde, Sergio, Albert D. Windhorst, Martin Behe, et al. "EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)." European Journal of Nuclear Medicine and Molecular Imaging 41, no. 11 (2014): 2175–85. http://dx.doi.org/10.1007/s00259-014-2866-8.
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Chiti, Arturo. "Introduction to EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)." European Journal of Nuclear Medicine and Molecular Imaging 41, no. 11 (2014): 2174. http://dx.doi.org/10.1007/s00259-014-2894-4.
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Myrtaj, Luiza. "The Importance of the Portfolio on Students' Achievements." European Journal of Education 2, no. 1 (2019): 76. http://dx.doi.org/10.26417/ejed-2019.v2i1-57.
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This study presents the results of a research work, which aims to highlight the importance of the portfolio on students' achievements. The study aims to validate the hypothesis that the creation of a portfolio / portfolio is one of the major factors by which the teacher appreciates the student's progress. The purpose of the paper is to analyze the student's evaluation effect through the dossier and its impact on the results of their achievements. To substantiate the hypothesis we raised the research question of research: What impact does the file have on student assessment? From the results of the distributed questionnaires, we could understand that a file should show a student's story. From the results of the research, we have come to the conclusion that students are familiar with the preparation, purpose of drafting the dossier and see it as a very good option in their final assessment. The data was obtained through questionnaires. The study was attended by 27 students studying at the secondary school “Kongresi i Manastirit "in Tirana", who attended classes VI-IX. Student subjects have been studied according to these variables: age, gender, classes that teach.
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Patel, Dhruvi H., Jitendra Kumar Badjatya, and Amit A. Patel. "PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION." International Journal of Drug Regulatory Affairs 5, no. 2 (2017): 1–12. http://dx.doi.org/10.22270/ijdra.v5i2.196.
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Lipska, Iga, Neil McAuslane, Hubert Leufkens, and Anke Hövels. "A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLAND." International Journal of Technology Assessment in Health Care 33, no. 3 (2017): 350–57. http://dx.doi.org/10.1017/s0266462317000563.
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Objectives: The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources.Methods: We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information.Results: The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria.Conclusions: While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the “pragmatic” HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.
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Lovkova, A. O., S. M. Gyulakhmedova, A. A. Druzhinina, and A. A. Nekipelova. "Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers." Safety and Risk of Pharmacotherapy 11, no. 4 (2023): 463–72. http://dx.doi.org/10.30895/2312-7821-2023-11-4-463-472.
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Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance documents, particularly the risk management plan (RMP). In practice, the changed EAEU GVP has resulted in multiple errors, creating the need to thoroughly analyse their structure and causes and to develop recommendations for their prevention.Aim. This study aimed to identify, analyse, and collate inconsistencies between the information submitted by marketing authorisation holders in their RPMs and the updated EAEU GVP requirements.Materials and methods. The Scientific Centre for Expert Evaluation of Medicinal Products analysed 50 RMPs received after 6 December 2022 as part of registration dossiers aimed to support marketing authorisation applications and/or align the registration dossiers with the EAEU requirements.Results. The errors made by applicants when preparing RMPs were categorised according to their influence on the interpretation of a medicinal product’s safety profile. The errors leading to incorrect safety profile interpretations were considered type 1 errors (63% of the cases). The errors affecting the perception of the RMP but not the interpretation of the safety profile (e.g., grammatical errors, notes and comments by applicants, incorrect translation of terms) were deemed type 2 errors (37% of the cases). The majority of EAEU GVP noncompliance cases were detected in Part II of the RMP, the section providing the most information on the safety profile of a medicinal product.Conclusions. There are several ways to improve the quality of RMP preparation. The information included in the RMP should be compared with the information provided in the registration dossier. The RMP should be incorporated into the integrated pharmaceutical quality system according to the requirements of good practices.A responsible employee of the marketing authorisation holder’s quality assurance system should control the final RMP version. Employees of pharmacovigilance departments should receive regular training.
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Drelich, Ewelina, Urszula Religioni, Kevin Chung, et al. "The Quality and Reliability of Information in the Summaries of Product Characteristics." International Journal of Environmental Research and Public Health 19, no. 4 (2022): 2185. http://dx.doi.org/10.3390/ijerph19042185.
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The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals. A necessary condition for this is to ensure that the SmPC is clear and precise. However, neither European nor national legislation obliges marketing authorization holders to review the SmPC in terms of its readability and understandability prior to the registration of a medicine. To date, research on SmPCs has focused on accuracy and completeness; however, the literature lacks information on the extent to which SmPCs meet the needs of healthcare professionals concerning the readability of the information they contain. The main objective of this article is to point out the lack of precision in the legal provisions for the preparation of SmPCs concerning the comprehensibility of the provisions. The article points to the lack of testing of the SmPC in terms of accessibility and transparency for healthcare professionals, highlighting that the document does not meet the needs of healthcare professionals in providing adequate information about medicines. It shows that the current rules and guidelines for the preparation of the registration dossier for a medicinal product are not entirely precise and contain numerous shortcomings.
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AESAN, Scientific Committee. "Guidelines of the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) on the information required to perform the assessment of processing aids that are intended to be used in the preparation and production of food." Revista del Comité Científico de la AESAN, no. 38 (December 14, 2023): 11–24. https://doi.org/10.2903/fr.efsa.2024.FR-0019.
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*This record is given in both English and Spanish The processing aids used in food preparation and production processes are regulated in Spain by Royal Decree 773/2023, which also defines them. There is also a specific regulation for the processing aids used in the production process of edible oils, which are regulated by Royal Decree 640/2015.As established in said Royal Decrees, the processing aids that do not appear in Annex I, and that are not referred to in sections 2 and 3 of Article 3, of Royal Decree 773/2023, and the processing aids used in the production process of edible oils that do not appear in Annex I of Royal Decree 640/2015 must be subject, for their approval and inclusion in said annexes, to a risk assessment by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) that establishes the safety of the intended use.In this regard, and in order to specify what information is necessary to evaluate the safety of the use of said processing aids and thus facilitate the submission of the assessment application dossiers, the AESAN Scientific Committee has developed these guidelines that are an amendment of those approved by the AESAN Scientific Committee in 2010, which they replace.They establish a series of guidelines regarding the submission of processing aid assessment ap-plications, in addition to the documentation that must accompany said applications, in the form of a dossier, which will include information regarding: administrative details and general presentation; detailed composition and specifications; stability and reactivity; authorised uses in human food; technological function; toxicological reference values; allergenicity; efficacy; residues and environmental impact.
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Madagoni, Krishna, Uppunuri Saidireddy, and Himaja . "A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies." INTERNATIONAL JOURNAL OF APPLIED PHARMACEUTICAL SCIENCES AND RESEARCH 1, no. 04 (2017): 133–46. http://dx.doi.org/10.21477/ijapsr.v1i4.6892.
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Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.
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Yadav, Neelima, and Navanil Chattopadhyay. "Traditional Vernacular Architecture of Kumaon: The Case of the Hill Towns of Munsiyari, Uttarakhand." Journal of Traditional Building, Architecture and Urbanism, no. 2 (November 10, 2021): 347–58. http://dx.doi.org/10.51303/jtbau.vi2.523.
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Munsiyari is a region located at an altitude of 2,200 meters in the hilly state of Uttarakhand, India. The eponymous town is surrounded by twenty-two villages mostly inhabited by Bhotiya tribes, who once formed a community that traded with those crossing from India to Tibet, though this trade came to an abrupt end with the 1962 Sino-Indian war. Owing to the region’s prosperity, the villages exhibit a very interesting typology of hill architecture. This architectural identity is also a manifestation of a geographical and cultural response to a difficult terrain. Our study was carried out as part of the preparation of a dossier for inventorying the Kailash sacred landscape with the aim of documenting the present state of the traditional vernacular heritage of the selected indigenous community for the UNESCO nomination of the wider region. That thorough documentation process was used as a means of analyzing local vernacular heritage and its current situation, and with a view to offsetting the rapid transformation of the past two decades.
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Sachuk, R. M. "DEVELOPMENT OF QUALITY CONTROL METHODS FOR A FINISHED IODINE- CONTAINING MEDICINAL PRODUCT IN THE STUDY OF THE DISCIPLINE "CHEMISTRY OF MEDICINAL PRODUCTS"." One Health Journal 2, no. II (2024): 23–29. http://dx.doi.org/10.31073/onehealthjournal2024-ii-03.
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The paper highlights the main issues related to the development of methods of quality control of input materials (methods of control of input raw materials), active and auxiliary substances of raw materials, quality control of the ready-to-use veterinary medicinal product "Iodozol", when studying the discipline "Chemistry of medicinal products" by students of higher education. The main questions that may arise for students when developing appropriate specifications for ready-made medicinal products are analyzed. The study was based on the study of the materials of the registration dossier for the veterinary medicine "Iodozol" (solution for intrauterine use, aerosol), obtained from the author's own experience. The article presents the main aspects of the development of quality control methods for the veterinary preparation "Iodozol", an integral stage of which is, in fact, the development of methods for controlling the active and auxiliary substances of the medicine. The analysis and introduction of theoretically based quality control methods for the veterinary medicinal product "Iodozol" into pedagogical activities will allow students to systematize the acquired knowledge, practical skills and their use in future professional activities
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Esposito, Laura. "Os documentos do palimpsesto de Santa Sofia di Benevento (século XI) estudados através da técnica de “imagem multiespectral”." LaborHistórico 10, no. 1 (2024): e63282. http://dx.doi.org/10.24206/lh.v10i1.63282.
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Although the palimpsests codes are not longer a rarity, the rescripti documents are still very rare. It was the practice of reusing parchments already written, then erased and subjected to a particular treatment, for the purpose of recycling for the preparation of a new document. The study in question examines the parchments of Santa Sofia di Benevento and the conspicuous dossier consisting of documents concerning the monastery of Sant’Angelo di Ariano. The membranes examined for this study are twenty-two (twenty-one have double palimpsests, while one is triple), for a total of forty-five documents, all relating to the eleventh century. The new multispectral imaging technique has allowed the identification of new occurrences relating to the sofiano parchment background, through the experimentation of multispectral digital photography and the digital manipulation of dissected images, able to bring out, in their clarity, the traces of the writings no longer visible either to the naked eye, or through the classic use of the Wood Lamp; this new photographic technique allows the isolation and separation of one or more levels of writing.
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Azeredo Seidel, Daniel. "A IMPORTÂNCIA DO PRONTUÁRIO DE INSTALAÇÕES ELÉTRICAS (PIE) NA INDÚSTRIA: LIÇÃO APRENDIDA COM ACIDENTE REAL." Revista Científica Semana Acadêmica 13, no. 258 (2025): 1–12. https://doi.org/10.35265/2236-6717-258-13164.
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Industrial safety is crucial, considering the high cost of accidents that affect both the victims and the companies, as well as society. Brazil records over 600,000 workplace accidents annually, with a notable 2,089 electrical accidents in 2023. The implementation of Electrical Installation Dossier (EID) is a vital strategy to prevent or minimize tragedies, saving lives and protecting company assets. Regulatory Standard NR-10, which governs safety in electrical installations, requires the preparation and maintenance of the EID, a fundamental document to ensure worker safety. Failure to implement and update the EID can result in severe consequences, as evidenced by several industrial accidents. This article discusses the importance of the EID, emphasizing the need for effective implementation and continuous updates. The research is based on a literature review and analysis of real cases, highlighting how the lack of updated EID directly contributes to the severity of accidents. It concludes that a wellstructured EID is essential for accident prevention and worker protection, requiring a continuous commitment to safety in the industrial environment.
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Foteeva, A. V., N. A. Koneva, and N. B. Rostova. "On the Issue of the Effectiveness of the Department for Registration of Medicines." Drug development & registration 11, no. 4 (2022): 133–38. http://dx.doi.org/10.33380/2305-2066-2022-11-4(1)-133-138.
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Introduction. New requirements for the registration of generic drugs after the entry of the Russian Federation into the Eurasian Economic Union (EAEU) and the signing of the Agreement on Common Principles and Rules for the Circulation of Medicinal Products identified a number of problems and opportunities that specialists in drug registration and working with regulatory authorities. The presented prospects for drug registration predetermine the list of tasks for the reorganization of the work of the department for work with regulatory authorities and the need to improve the competence of the employees of the manufacturers in order to carry out effective work.Aim. Assessing critical steps in the generic drug registration process to improve the efficiency and organization of the Regulatory Affairs department.Materials and methods. The materials of the study were available publications in peer-reviewed journals on thematic queries compiled according to the keywords of the chosen subject, official websites, regulatory legal acts regulating the procedure for registering drugs in the Russian Federation, the EAEU and foreign countries.Results and discussion. A brief overview of regulatory issues on drug registration according to the requirements of the Eurasian Economic Union is presented. The critical stages of the drug registration process and the tasks that need to be solved in order to ensure the effective work of the department for working with regulatory authorities in the implementation of drug registration processes in the Russian Federation, the EAEU and other countries were identified. The role of professional qualifications of specialists involved in the preparation of the registration dossier and the processes of registration of medicines is indicated.Conclusion. Changes in the legal regulation of the registration process and the imperfection of the requirements for specialists who carry out the procedures for preparing the registration dossier determine the need to develop organizational technologies and measures at the organization level aimed at standardizing all processes and forming professional specialized competencies of personnel.
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Sachuk, R. M., L. M. Y. Kostyshyn, B. V. Gutyj, et al. "DEVELOPMENT OF SPECIFICATION AND CONTROL OF INPUT MATERIALS FOR THE MANUFACTURE OF AMOXICILLINE-TRIHYDRATE BASED PREPARATION." Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology 23, no. 1 (2022): 154–60. http://dx.doi.org/10.36359/scivp.2022-23-1.22.
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To characterize and determine the quality of the veterinary medicinal product «Amoxidev 60» (powder for oral use) which contains amoxicillin trihydrate, in addition to physical and chemical tests, it is important to develop a specification and control of input materials intended for its production.
 The aim of the study was to create a drug based on amoxicillin trihydrate of appropriate quality and to substantiate the specification of control of input materials intended for its production.
 Veterinary drug «Amoxidev» - water-soluble white powder with a specific odor. One gram of the drug contains the active substance: amoxicillin trihydrate – 600 mg and filler: lactose – up to 1 g.
 The drug is prescribed to zoo animals - European deer, ornamental birds (pheasant, peacock) for the treatment and prevention of respiratory diseases (rhinotracheitis, bronchopneumonia, pneumonia), digestive (gastroenteritis, enterocolitis), genitourinary systems (metritis, nephritis, rubella) apparatus and soft tissues (injuries, myositis, dermatitis, mastitis) caused by microorganisms sensitive to the drug.
 Control of raw materials included the following operations: determination of the mass fraction of amoxicillin trihydrate; testing; preparation of control solution; chromatography; testing of amoxicillin trihydrate for purity; testing of amoxicillin trihydrate for the presence of accompanying impurities; determination of the pH of the test solution and the transparency of the substance solution.
 Based on the proposed specification and approaches to laboratory quality control of powder for oral use based on amoxicillin trihydrate developed production documentation that corresponds to the registration dossier for the veterinary drug «Amoxidev 60». The test results are properly investigated and documented in accordance with the Operating Standards Standard (SOP).
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Shah, K. "Documentation and Cultural Heritage Inventories - Case of the Historic City of Ahmadabad." ISPRS Annals of Photogrammetry, Remote Sensing and Spatial Information Sciences II-5/W3 (August 12, 2015): 271–78. http://dx.doi.org/10.5194/isprsannals-ii-5-w3-271-2015.
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Located in the western Indian state of Gujarat, the historic city of Ahmadabad is renowned for the unparalleled richness of its monumental architecture, traditional house form, community based settlement patterns, city structure, crafts and mercantile culture. This paper describes the process followed for documentation and development of comprehensive Heritage Inventories for the historic city with an aim of illustrating the Outstanding Universal Values of its Architectural and Urban Heritage. The exercise undertaken between 2011 & 2014 as part of the preparation of world heritage nomination dossier included thorough archival research, field surveys, mapping and preparation of inventories using a combination of traditional data procurement and presentation tools as well as creation of advanced digital database using GIS. The major challenges encountered were: need to adapt documentation methodology and survey formats to field conditions, changing and ever widening scope of work, corresponding changes in time frame, management of large quantities of data generated during the process along with difficulties in correlating existing databases procured from the local authority in varying formats. While the end result satisfied the primary aim, the full potential of Heritage Inventory as a protection and management tool will only be realised after its acceptance as the statutory list and its integration within the larger urban development plan to guide conservation, development and management strategy for the city. The rather detailed description of evolution of documentation process and the complexities involved is presented to understand the relevance of methods used in Ahmadabad and guide similar future efforts in the field.
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V. Nivedita, Sridaraneesh Navendran, Sharath Anand, and Dhanesh N. "Dental disease detection using deep learning with X-ray." International Journal of Science and Research Archive 15, no. 2 (2025): 119–24. https://doi.org/10.30574/ijsra.2025.15.2.1275.
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Dental afflictions, in another way investigated and treated in a convenient way, can influence weighty energy issues and a prejudiced quality of history. Conventional plans of disease are very weak on expert reading of dental radiographs or dispassionate figures, that understand expected time-consuming and dependent on something human instability. This paper presents a survey of a mechanical arrangement for dental affliction detection established the use of deep education procedures improved accompanying Generative Adversarial Networks (GANs). Convolutional Neural Network (CNN) is employed for exact categorization of various dental environments like sunken or decayed areas, periodontitis, and gingivitis from intraoral concepts and dental radiographs. To surmount the disadvantage of limited and unstable dossier, GANs are employed to create artificial finest different dental countenances, filling out the preparation dataset and leading to model inference. Additionally, bureaucracy takes advantage of explicable AI plans to visualize and stress the distressed domains, that aid dental experts during dispassionate administrative. Experimental effects story that the bestowed foundation provides extreme accuracy, veracity, and recall, beat normal methods. This research focal points the potential of joining GANs and deep knowledge to offer powerful, ascendable, and evident-time dental affliction disease.
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Di Iorio, Valentina, Stefano Boschi, Cristina Cuni, et al. "Production and Quality Control of [177Lu]Lu-PSMA-I&T: Development of an Investigational Medicinal Product Dossier for Clinical Trials." Molecules 27, no. 13 (2022): 4143. http://dx.doi.org/10.3390/molecules27134143.
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Since prostate cancer is the most commonly diagnosed malignancy in men, the theranostic approach has become very attractive since the discovery of urea-based PSMA inhibitors. Different molecules have been synthesized starting from the Glu-urea-Lys scaffold as the pharmacophore and then optimizing the linker and the chelate to improve functional characteristics. This article aimed to highlight the quality aspects, which could have an impact on clinical practice, describing the development of an Investigational Medicinal Product Dossier (IMPD) for clinical trials with [177Lu]Lu-PSMA-I&T in prostate cancer and other solid tumors expressing PSMA. The results highlighted some important quality issues of the final preparation: radiolabeling of PSMA-I&T with lutetium-177 needs a considerably longer time compared with the radiolabeling of the well-known [177Lu]Lu-PSMA-617. When the final product was formulated in saline, the stability of [177Lu]Lu-PSMA-I&T was reduced by radiolysis, showing a decrease in radiochemical purity (<95% in 24 h). Different formulations of the final product with increasing concentrations of ascorbic acid have been tested to counteract radiolysis and extend stability. A solution of 20 mg/mL of ascorbic acid in saline prevents radiolysis and ensures stability over 30 h.
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Sisto, Michele, and Angela Cresta. "The Valorisation of an Ancient Traditional Practice for the Promotion of Rural and Sustainable Tourism: The “Tracing of the Straight Furrow” in Central and Southern Italy." Highlights of Sustainability 2, no. 1 (2023): 16–34. http://dx.doi.org/10.54175/hsustain2010003.
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The aim of this original contribution is to present the procedures and process initiated by some municipalities in inland areas for the inclusion of an ancient rural tradition, practiced in south-central Italy—the “Tracing of the straight furrow”—in the “National Register of Rural Landscapes of Historic Interest, Agricultural Practices and Traditional Knowledge”. The registry proposes to identify and catalog in a database the rural landscapes, practices and knowledge worthy of importance to safeguard their integrity and vulnerability. The article describes the research activity that was implemented to record the practice, and also wants to show that the standard procedure prepared by the Ministry cannot consist only of desk analysis (data collection, and preparation of the required dossier). Indeed, there is a need to initiate a process that, starting with the proposing institutions, involves local actors and communities who are familiar with traditional places and practices. Citizen participation in this decision-making process that implements the area’s tourism-cultural development policies is also essential to consolidate intra-generational and local relationships: desk analysis is thus enriched by field analysis. This makes it possible to highlight problems/potentialities and help in the selection of contextualized solutions to encourage adherence to initiatives especially after recognition of traditional practice in the National Register.
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Ali Memed, Oja, Ivana Klinkarova, and Marija Glavas Dodov. "Importance of Quality by Design (QbD) approach during development of modified release film-coated tablet - objectives and challenges during implementation and preparation of dossier." Macedonian Pharmaceutical Bulletin 69, no. 03 (2023): 225–26. http://dx.doi.org/10.33320/maced.pharm.bull.2023.69.03.110.
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Katsaraba, O. A., R. M. Sachuk, Ye Ye Kostyshyn, Y. S. Stravskyy, and L. M. Ye Kostyshyn. "Research on the therapeutic effectiveness of the veterinary medicinal product “Surfadev” in complex therapy for stimulating sexual desire in cows." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 25, no. 112 (2023): 140–44. http://dx.doi.org/10.32718/nvlvet11223.
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Clinical studies were conducted in the treatment of hypofunction of the ovaries to increase the fertility of cows and heifers with the newly created drug “Surfadev” (solution for injections) in complex therapy. VLZ “Surfadev” (solution for injections). The drug stimulates the secretion of gonadotropins by the pituitary gland in a maximum of 2–3 hours after administration. The increased content of gonadotropins in the blood persists for 4–5 hours after administration. Unlike natural luliberin, the biological activity of the drug is 50 times greater, which allows the use of this drug in microdoses and short courses. The drug decomposes under the influence of enzymes more slowly than natural luliberin, which provides a stronger biological effect on the pituitary gland. “Devivit Complex” is a complex multivitamin preparation (Vitamins A, D3, E, B1, B2, B3, B5, B6, B12), which is used to correct and normalize metabolic processes in animals. Vitamins included in the preparation take part in biochemical processes in animal organisms (in the form of enzyme vitamins, hormone vitamins, antioxidants). When ovarian function is stimulated or corrected, 90.0 % of the treated animals show the arousal stage of the sexual cycle within 3–15 days, and their fertilization rate from the first insemination is 70.0 % on average. The high efficiency of using “Surfadev” in combination with “Devivit Complex” for ovarian hypofunction has been established. 83.3–95.6 % of the treated cows showed sexual desire, and the fertility from the first insemination reached 70.0 %. Further studies will be the next stage of pre-registration trials aimed at studying the effectiveness of the veterinary drug “Surfadev” (solution for injections) in complex therapy in the treatment of ovarian hypofunction and follicular cysts, which is mandatory material of the fourth part “Preclinical and clinical documentation” of the dossier for this medicine.
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Almakaeva, LG, LG Naumenok, NV Begunova, VG Dolya, and MS Almakaev. "DEVELOPMENT OF DOMESTIC INFUSION DRUGS BASED ON PARACETAMOL." Annals of Mechnikov Institute, no. 2 (November 18, 2016): 65–68. https://doi.org/10.5281/zenodo.167497.
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The intravenous form of paracetamol compared with oral more reliably supports effective drug concentration in blood plasma that promotes a higher therapeutic effect. Recent studies have confirmed that the use of the intravenous form of paracetamol to deal with postoperative pain multimodal analgesia modes results in reducing the frequency and quantity of opioids administered , and, as a consequence, its associated side effects. The drug Paracetamol , infusion solution 10 mg / ml to 100 ml glass bottles is a drug - generic . His qualitative and quantitative composition is developed from the study of literature data about the drug - similar to " Perfalhan , 10 mg / ml solution for infusion in 100 mL " company Bristol - Myers Squibb, France and experimental work. The aim of our study is development and support of the national composition of the infusion of the drug on the basis of paracetamol, selection of excipients that provide stability of the active substances. Materials and methods. The object of the study was the substance of paracetamol manufactured by Zhejiang Kangle Pharmaceutical Co. , Ltd, China. During the work conducted qualitative and quantitative monitoring sample preparation for indicators of stability: pH content of the active ingredient , transparency, color, impurities , contamination by the methods described in the SFU [and nor- ral documentation to the drug . One potential factor of instability is the effect of paracetamol oxygen, due to the presence in the molecule of paracetamol and -NH possibility of oxidation. Results and Discussion. Paracetamol is derived atsetamina . Substance acetylation are p - aminophenol with acetic anhydride . Saturated aqueous solution has a pH of paracetamol - ment about 6 . Paracetamol is a crystalline white powder , sparingly soluble in water, soluble in 96% alcohol, very slightly soluble in metilenhloride . . Active substance enters in comparison drug in the concentration of 10 mg/ml. Stable aqueous solution decreases in acidic and alkaline environments where paratse - tamol gradually destroyed to acetic acid or p - aminophenol To prevent oxidation of the drug administered antioxidant - sodium metabisulfite in concentrations generally 1.0 g / l. In order to prevent the negative - tive impact of oxygen on paracetamol solution 10 mg / mL drug preparation was conducted under nitrogen gas protection . It is established that the use of nitrogen gas protection affects the quality of the drug. Prepared sample preparation without nitrogen gas protection did not meet project MKYA in terms of " 4 - aminophenol " and " color ", besides a slight tendency pH change and reducing quantitative content of active ingredient. Therefore, the production of the drug " Paracetamol , infusion solution 10 mg / ml. in bottles of 100 ml " necessary solution prepared bubbling nitrogen for 20 minutes. It is established that the use of nitrogen gas protection affects the quality of the drug. the manufacture of the drug " Paracetamol , infusion solution 10 mg / ml. in bottles of 100 ml " necessary solution prepared bubbling nitrogen for 20 minutes. Calculated theoretical osmolarity of the drug- 299,47 мОsм / l. Solution osmolarity close to osmolarity of blood, which is an important criterion when used in injection therapy. Conclusions. Theoretically grounded and experimentally confirmed rational composition drug infusion composition based on paracetamol. Selected auxiliaries and processing methods in the preparation of the solution , prevents oxidation of the main active ingredient , and also provide the optimum level of osmolarity solution. Results of this development are used during compile of registration dossier of preparation, analytical and technological normative documents on his production and control of quality of intermediate products and prepared products.
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Sachuk, R. M., B. V. Gutyj, Ya S. Stravskyy, O. A. Katsaraba, O. V. Dyshkant, and L. V. Kalynovska. "Research on the specific toxicity of the drug “BTF plus” – a means for nor-malizing metabolic processes in animals and poultry." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 25, no. 111 (2023): 33–42. http://dx.doi.org/10.32718/nvlvet11106.
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Laboratory studies were conducted to determine the subacute toxicity and tolerance of the veterinary drug “BTF plus” on white rats, dogs, and guinea pigs. The “BTF plus” preparation is a complex vitamin and mineral preparation based on butophosphane, L-carnitine, and cyanocobalamin, which normalizes and corrects metabolic processes in animals and poultry. The drug is used for various types of animals and poultry as a stimulating, tonic and general strengthening agent for obstetric pathologies (difficult births, postpartum complications, paresis, eclampsia, sexual cycle disorders); metabolic disorders caused by irrational feeding, malnutrition, asthenic syndrome, etc.; anemia with helminthiasis; secondary anemias, as an additional means in the treatment of magnesium and calcium deficiency; to increase muscle activity, with significant loads, overstrain and exhaustion in animals; to increase the body's resistance to various pathogens; to stimulate growth, development and live weight gain in young animals and poultry; as an additional means in the treatment of diseases caused by various factors (infectious and non-infectious origin). When administered subcutaneously to rats, the drug “BTF plus” under the conditions of a subacute toxicological experiment in doses (by absolute weight of the drug) of 200.0, 1000.0, and 2000.0 mg/kg of body weight does not cause hemo-, hepato- and nephrotoxic effects on the body of laboratory animals, but on the contrary, stimulates hematopoietic processes and has a positive effect on metabolic processes in their body. Subcutaneous administration of the drug “BTF plus” to dogs in doses (by absolute weight of the drug) of 200.0, 1000.0, and 2000 mg/kg of body weight for ten days does not cause hepatotoxic and nephrotoxic effects on the body under the conditions of a subacute toxicological experiment, but on the contrary, stimulates hematopoietic processes and has a positive effect on metabolic processes in the body of target animals. The tolerance of guinea pigs to the drug “BTF plus” was studied. It was established that the drug does not hurt the body and behavior of ants when administered subcutaneously in doses (based on the absolute weight of the drug) (5000,0–15000,0) mg/kg of body weight. Further studies will be the next stage of pre-registration tests aimed at studying the embryotoxic and carcinogenic effect of “BTF plus”, which is mandatory material of the “Safety and residue studies” section of the dossier for this medicinal product.
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Sachuk, R. M., T. A. Velesik, Ya S. Stravsky, et al. "PHARMACOTECHNOLOGICAL QUALITY INDICATORS OF THE VETERINARY DRUG BASED ON CALCIUM GLUCONATE." Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology 24, no. 1 (2023): 163–70. http://dx.doi.org/10.36359/scivp.2023-24-1.22.
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In order to characterize and determine the quality of the veterinary medicinal product «Solution of calcium borgluconate 20%» (solution for injections), which contains calcium gluconate, its proper production, quality control and appropriate storage remain important.
 The purpose of the research is to develop the characteristics of the finished medicinal product, manufacturing technology and methods of quality control of the active substance and auxiliary substances of the injectable medicinal product based on calcium gluconate.
 The veterinary drug «Solution of calcium borogluconate 20%» is a transparent, colorless, non-viscous liquid with a specific smell. 100 ml of the drug contain the active substance – calcium gluconate – 20,0 g. Excipients: boric acid, butyl alcohol, water for injections.
 The drug is prescribed for the prevention and treatment of animals, for diseases caused by insufficient or reduced calcium metabolism in the body: rickets, hemorrhagic diathesis, urticaria, prenatal and postpartum addictions, postpartum paresis, tetany during pregnancy, as well as allergies and toxicosis.
 The work presents the characteristics of the finished veterinary medicinal product «Solution of calcium borogluconate 20%» (solution for injections), describes the technological features of manufacturing and standardization of the calcium-containing preparation, and offers a specification for the active substance and auxiliary substances. Standardization of the injection drug includes: checking the appearance of the incoming raw materials, identification of active substances, quantitative determination of the active substance and excipients.
 On the basis of the proposed specification and approaches to laboratory quality control of the solution for injections based on calcium gluconate, production documentation was developed that corresponds to the materials of the registration dossier for the veterinary drug «Solution of calcium borogluconate 20%». Test results are properly investigated and documented in accordance with the standard operating procedure (SOP).
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Sachuk, R. M., B. V. Gutyj, T. A. Velesyk, et al. "Experimental evaluation of the acute toxicity and irritant effect of “BTF plus” – a veterinary medicinal product for the normalization of metabolic processes in animals and poultry." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 25, no. 99 (2023): 14–21. http://dx.doi.org/10.32718/nvlvet-a9903.
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Laboratory studies were conducted to determine the acute toxicity of the veterinary drug “BTF plus” on white rats and white mice. The preparation “BTF plus” is a complex vitamin and mineral preparation, which is used to normalize and correct metabolic processes in poultry and animals. The drug is used for various types of animals and poultry as a stimulating, tonic and general strengthening agent for: obstetric pathologies (difficult births, postpartum complications, paresis, eclampsia, sexual cycle disorders); metabolic disorders caused by irrational feeding, malnutrition, asthenic syndrome, etc.; anemia with helminthiasis; secondary anemias, as an additional means in the treatment of magnesium and calcium deficiency; to increase muscle activity, with significant loads, overstrain and exhaustion in animals; to increase the body’s resistance to various pathogens; to stimulate growth, development and live weight gain in young animals; as an additional means in the treatment of diseases caused by various factors (infectious and non-infectious origin). Based on the results of determining the parameters of the acute toxicity of the drug “BTF plus” in the case of a single intragastric administration to white female rats, it was not possible to calculate the LD50, since the death of laboratory animals was not detected within 14 days after administration. At the same time, the maximum injected dose (based on the absolute weight of the drug) was 40000.0 mg/kg of body weight, which allows the drug to be classified as VI class of toxicity – the substances are relatively harmless (LD50 > 15000.0 mg/kg of body weight), and according to the degree of danger to IV class – low-hazardous substances (LD50 > 5000.0 mg/kg of body weight). Based on the results of determining the parameters of the acute toxicity of the drug “BTF plus” in the case of a single subcutaneous injection to white female rats and male mice, it was not possible to calculate the LD50, since the death of laboratory animals was not detected within 14 days after administration. At the same time, the maximum injected dose (based on the absolute weight of the drug) was 20000,0 and 40000.0 mg/kg of body weight for both species of animals, respectively, which allows it to be classified as VI class – relatively harmless substances (LD50Subcut > 4500 mg/kg of body weight). Further studies will be the next stage of pre-registration tests aimed at studying the embryotoxic effect of “BTF plus”, which is mandatory material of the “Safety and residue studies” section of the dossier for this drug.
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Кychan, М. В., R. О. Vasiv, R. M. Sachuk, and L. V. Kalynovska. "PHARMACOCHEMICAL AND TECHNOLOGICAL QUALITY INDICATORS OF THE VETERINARY MEDICINAL PRODUCT BASED ON BIRCH TAR." Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology 25, no. 1 (2024): 52–61. http://dx.doi.org/10.36359/scivp.2024-25-1.07.
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To characterize and determine the quality of the veterinary medicinal drug «Kubazol» (solution for external use, aerosol), which includes birch tar as an active substance and auxiliary substances: ethyl acetate, polybutyl methacrylate, it is important to control the quality of the incoming raw materials and properly manufacture the medicinal product. The purpose of research is the development of a leaflet-tab of a veterinary drug, methods of quality control of the active substance and auxiliary substances of a solution for external use based on birch tar, and the technology of drug production. The veterinary drug «Kubazol» is a viscous liquid from yellow to brown in color with a specific smell of its components. 1 ml of the drug contains: birch tar – 40 mg, auxiliary substances: ethyl acetate, polybutyl methacrylate – up to 1 ml. «Kubazol» is prescribed for the treatment and prevention of lesions of the skin (wounds, dermatitis, eczema), claws (injuries, superficial panaritium), hooves (rot of the hooves, etc.) in dogs, wild pigs, wild birds, sport horses and pigs (boars after castration). The work presents the characteristics of the raw materials of the veterinary medicinal drug «Kubazol» (solution for external use, aerosol), describes the technological features of the manufacture and standardization of the drug based on birch tar, and offers a specification for the active substance and auxiliary substances. The technological scheme for the production of the drug included: preparation of aluminum cylinders, filling with the finished solution, removal of air from the cylinders, fastening of the valve, introduction of the propellant, testing for strength and tightness, drying of the cylinders, pressure testing, installation of the atomizer and checking of the quality of spraying and marking. On the basis of the proposed specification and approaches to laboratory quality control of the solution for external application of an aerosol based on birch tar, production documentation was developed that corresponds to the materials of the registration dossier for the veterinary drug «Kubazol». Test results are properly investigated and documented in accordance with the Standard Operating Procedure (SOP).
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Shah, Khushi. "Creation of cultural heritage inventories: case of the historic city of Ahmadabad." Journal of Cultural Heritage Management and Sustainable Development 6, no. 2 (2016): 166–94. http://dx.doi.org/10.1108/jchmsd-02-2016-0011.
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Purpose – The purpose of this paper is to illustrate the relevance of cultural heritage inventories and documentation as critical tools for heritage conservation and management in historic cities, through the case study of the historic city of Ahmadabad, India. Design/methodology/approach – The paper discusses the creation of inventories as part of the comprehensive documentation undertaken for preparation of the World Heritage nomination dossier. In this context, the goal of preserving the outstanding universal value of the historic city formed the basis for selection and assessment of the assets to be included in the inventory. Standard processes and methodology employed for creation of the database involved archival research and planning; field surveys for mapping, photo documentation and data collection; data registration and processing using CAD, Ms Office and geographic information system (GIS)-based digital platform. Optimal data acquisition while maintaining cost and time efficiency was an important consideration for the fieldwork. Findings – While an inventory remains a critical conservation tool, the heritage assets are integrally linked to and influenced by their surroundings in an urban context. A comprehensive documentation approach that provides a broader understanding of the city’s natural features, built environment, heritage resources, cultural practices and socio-economic networks is therefore necessary for creation of a suitable management plan for historic cities. Traditional field surveys based on external visual observation are time and cost effective, and can generate adequate information on identification and assessment of built heritage assets for creation of inventory along with documentation of their context. However, the scale of investigation and the intended role of an inventory as an urban management tool calls for creation of integrated, accessible and updatable data management systems. Research limitations/implications – At the moment, the database created is only used for the limited purpose of monitoring and managing the conservation of listed properties. The importance of the inventory as a critical conservation and urban management tool can be further validated once the GIS database of the historic city is integrated within the urban management and planning system for the city. Originality/value – The inventory created for the historic city of Ahmadabad offers one of the few examples of heritage documentation at such a large scale. It covers an area of 543 ha with a detailed inventory of more than 6,000 properties. The description of, and the reflections on the process employed provide an overview of usual challenges encountered in creation, presentation and management of heritage inventories for historic cities which may offer useful guidelines to practitioners planning similar exercises and help them establish efficient work processes.
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Karlton, Peter C., and David Johnston. "An Integrated Approach to the Preparation of Global CMC Dossiers." Drug Information Journal 31, no. 1 (1997): 237–42. http://dx.doi.org/10.1177/009286159703100133.
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Typhaine Beaupérin. "“Think small first in the EU”? A Reality Check." European Journal of Risk Regulation 5, no. 1 (2014): 93–96. http://dx.doi.org/10.1017/s1867299x00003019.
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Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.
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Egan, Rylan, Jessica Baumhour, Monica Mullin, et al. "Resident and Attending Physician Perceptions of a Quality and Safety Curriculum." Canadian Journal of General Internal Medicine 16, no. 3 (2021): e62-e73. http://dx.doi.org/10.22374/cjgim.v16i3.495.
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This study sought to identify opportunities for improvement of an Internal Medicine (IM) resident quality improvement (QI)/patient safety (PS) program at an academic teaching hospital. The authors conducted semi-structured interviews with 15 residents and 6 attending physicians, which were analyzed from an inductive and thematic lens using NVivo software. Ethics was approved by the institution’s Research Ethics Board (File #: 6026140). Four themes emerged from this analysis. Residents and attending physicians agreed on (i) integrating QI/PS knowledge and skills into practice using active learning approaches. However, there was concern that requiring QI project completion through (ii) standardization of QI/PS education could create a barrier to clinical research required for sub-specialization. There was agreement that the (iii) QI/PS culture within the IM program was supportive and that a lack of safe reporting efficiency within the hospital, along with interprofessional discord, could cause (iv) external barriers to QI/PS training. By integrating these findings, evidence-informed and low-resource solutions could be incorporated into the QI/PS curriculum that uses minimal preparation requirements, and fulsome conversation-based exploration of QI/PS techniques within real-world clinical cases. RésuméCette étude visait à trouver des possibilités d’améliorer un programme d’amélioration de la qualité (AQ)/sécurité des patients (SP) pour les résidents en médecine interne (MI) à un hôpital universitaire. Les auteurs ont mené des entrevues semi-structurées auprès de 15 résidents et de 6 médecins traitants, lesquelles ont été analysées d’un point de vue inductif et thématique à l’aide du logiciel NVivo. Le comité d’éthique de la recherche de l’établissement a approuvé cette recherche (dossier no : 6026140). Quatre thèmes sont ressortis de cette analyse. Les résidents et les médecins traitants sont d’accord sur les éléments suivants : i) l’intégration dans la pratique des connaissances et des compétences en AQ/SP au moyen d’approches d’apprentissage actif. Toutefois, on craint que l’obligation de mener à bien le projet d’AQ par l’intermédiaire de ii) l’uniformisation de l’enseignement de l’AQ/SP ne crée un obstacle à la recherche clinique requise pour la sous-spécialisation. Les participants s’entendent pour dire iii) que la culture de l’AQ/SP au sein du programme de MI est fondée sur le soutien et que le manque d’efficacité lié aux déclarations relatives à la sécurité au sein de l’hôpital ainsi que les désaccords interprofessionnels pourraient causer iv) des obstacles externes à la formation sur l’AQ/SP. En intégrant ces constatations, des solutions fondées sur des données probantes et nécessitant peu de ressources pourraient être incorporées dans le programme d’AQ/SP qui utilise des exigences minimales en matière de préparation et une exploration approfondie des techniques d’AQ/SP sur le mode de la conversation dans le cadre de cas cliniques réels.
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Hennebert, Pierre. "THE SUBSTITUTION OF REGULATED BROMINATED FLAME RETARDANTS IN PLASTIC PRODUCTS AND WASTE AND THE DECLARED PROPERTIES OF THE SUBSTITUTES IN REACH." Detritus, no. 16 (September 30, 2021): 16–25. http://dx.doi.org/10.31025/2611-4135/2021.15122.
Full textAbstract:
Plastics containing brominated flame retardants (BFR) currently contain both “legacy” regulated and non-regulated BFR (R-BFRs and NR-BFRs), as evidenced by the increasingly lower correspondence over time between total bromine and R-BFRs content. The portion of substitutive NR-BFR present in the plastics and their toxicity and ecotoxicity properties are documented. Data relating to plastics and foam present in electrical and electronic equipment (EEE), waste EEE, vehicles, textiles and upholstery, toys, leisure and sports equipment show how 88% of plastic waste contains bromine from NR-BFRs. BFR substances mentioned in the catalogs of the three main producers (Albemarle, ICL, Lanxess) and BFR on the official used list of 418 plastic additives in the EU were gathered and the toxic and ecotoxic properties of these compounds as listed in their ECHA registration dossier were compiled. Fifty-five preparations using 34 NR-BFRs substances, including polymers and blends, were found. Seventeen of these substances featured an incomplete dossier, 12 were equipped with a complete dossier, whilst 11 substances (including 2 ill-defined blends) should be reassessed. Eight substances have been notified for assessment by the ECHA as persistent, bioaccumulative and toxic, or as endocrine disruptors, including decabromodiphenylethane; 3 substances display functional concentrations (the concentration of additives that retards flame) exceeding the concentration limits classifying a waste as hazardous but are “reactive” (they bind to the polymer). The technical limit of 2 000 mg total Br/kg indicated for further recycling (EN 50625-3-1) relates to all brominated substances and is relevant in the sorting of all poorly classified new substances.
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Troosters, J. "Kwantitatieve en kwalitatieve toezichtsproblemen ten aanzien van de gefusioneerde gemeenten." Res Publica 24, no. 3-4 (2021): 609–24. http://dx.doi.org/10.21825/rp.v24i3-4.19318.
Full textAbstract:
With regard to the supervision of the municipalities by the provincial authorities, the sealing up has decreased the number of municipalities but not the volume of dossiers. Due to an increase of rather «difficult» municipalities because of the amalgamation, administrative control has become more difficult. The restriction on the number of local politicians has improved the quality of decision-making. Based on statistics, it seems that the negative character of the control has to be demystified. The evolution points toa diminishing of that phenomenon. Too little attention has been paid to the quality and quantity of the officials who have to manage the municipalities. The amalgamation has made further specialisation possible so there can be better job assignment of the municipal officials. Administrative and technical preparation of the dossiers has improved. The quality of the personnel dossiers is precarious which accounts for the fairly high number of suspension orders and negative decisions. The suspensions concerning personnel matters are a little higher in the municipalities of the Brussels agglomeration compared to Brabant as a whole.More flexible application of administrative control is not only possible and desirable but also justified in order that the constructive character of that administrative control may receive full attention.
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Kuhach, V. V. "PHARMACY MANUFACTURE AND QUALITY CONTROL OF MEDICINAL PREPARATIONS ABROAD." Vestnik Farmacii 92, no. 2 (2021): 64–79. http://dx.doi.org/10.52540/2074-9457.2021.2.64.
Full textAbstract:
The purpose of this work was to study foreign experience in pharmacy manufacture and quality control of medicinal preparations (MP). Scientific literature and internet sources analysis, the author's own observations from 2005 to 2020 were made. It has been established that pharmacy manufacture of MPs abroad is carried out for the special needs of patients when pharmaceutical industry cannot produce them for various reasons. There are various approaches to standardization of the number of manufacturing pharmacies abroad: from complete prohibition of pharmacy manufacture of medicinal preparations in Portugal to mandatory license requirement in Austria and Germany. To manufacture medicinal preparations at a pharmacy the laboratory is established where necessary equipment, inventory, pharmaceutical substances and excipients are placed and the technological process is carried out. Pharmacy manufacture of sterile medicinal preparations is conducted under aseptic conditions in a specially equipped room or in a laminar-airflow cabinet. MPs must not be registered in most countries of the world. In the US and the European Union (EU) medicinal preparations are classified into medicines for immediate use and for prolonged storage. Expiration date must be stated for prolonged storage medicinal preparations, a dossier is made for them in the EU pharmacies. Pharmacies in most countries of the world manufacture medicinal preparations from tablets and capsules. Much attention abroad is given to ensure the quality of pharmacy manufacture of medicinal preparations: in the US, pharmacy manufacture of medicinal preparations is carried out in accordance with the requirements of Pharmacopoeia, in the EU according to the EU Council Resolution. A number of countries have developed guidelines or standard operational procedures for pharmacy manufacture of medicinal preparations. Constant training and assessment of employees’ competencies engaged in pharmacy manufacture of medicinal preparations is performed.