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Journal articles on the topic 'Primary pharmaceutical manufacturing'

Author: Grafiati
Published: 4 June 2021
Last updated: 1 February 2022

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1

Sarin, Subhash C., Hanif D. Sherali, and Lingrui Liao. "Primary pharmaceutical manufacturing scheduling problem." IIE Transactions 46, no. 12 (2014): 1298–314. http://dx.doi.org/10.1080/0740817x.2014.882529.

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2

Ouranidis, Andreas, Christina Davidopoulou, Reald-Konstantinos Tashi, and Kyriakos Kachrimanis. "Pharma 4.0 Continuous mRNA Drug Products Manufacturing." Pharmaceutics 13, no. 9 (2021): 1371. http://dx.doi.org/10.3390/pharmaceutics13091371.

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Continuous mRNA drugs manufacturing is perceived to nurture flow processes featuring quality by design, controlled automation, real time validation, robustness, and reproducibility, pertaining to regulatory harmonization. However, the actual adaptation of the latter remains elusive, hence batch-to-continuous transition would a priori necessitate holistic process understanding. In addition, the cost related to experimental, pilot manufacturing lines development and operations thereof renders such venture prohibitive. Systems-based Pharmaceutics 4.0 digital design enabling tools, i.e., convergin
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3

Ngugi, Grace Wanjiru, and Esther Gitonga. "Generic Strategies and Performance of Pharmaceutical Manufacturing Companies in Nairobi County, Kenya." International Journal of Business Management, Entrepreneurship and Innovation 3, no. 1 (2021): 17–35. http://dx.doi.org/10.35942/jbmed.v3i1.157.

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Pharmaceutical industry has been facing a lot of competition both from the inside and outside the country (importers of raw materials who also manufacture finished product). A report by the Kenya Pharmaceutical Sector Profile in 2018 indicated that imports have been rising sharply and grew by more than 30% between 2017 and 2018 in other sectors but a decline from the pharmaceutical manufacturing sector which could be attributed to the low-quality pharmaceutical products. The aim of this study was to analyze the generic strategies and performance of pharmaceutical manufacturing companies in Nai
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Prabhakar V S, Beula Evangeline C, Aravindhanathan V, Sruthi N, and Gowthamarajan K. "Regulatory Comparative Quality Systems of India and USA and its Significance in Pharmaceutical Industry Facilities." International Journal of Research in Pharmaceutical Sciences 11, SPL4 (2020): 2457–62. http://dx.doi.org/10.26452/ijrps.v11ispl4.4498.

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The intentions of the current study are to compare the regulatory requirements of USFDA and CDSCO-Schedule M in GMP with significance to the pharmaceutical industry to speed up the criteria for enforcement to facilitate the regulatory approval of specified pharmaceutical products in the United States and India. The literature search is done using different resources, such as regulatory authority websites, pharmaceutical review articles, journals and public domains. To discuss the numerous dilemmas, root causes and challenges confront by pharmaceutical companies and to suggest remedial and pro-
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Aziza, Farida. "Comparison Review of Two Regulatory Agencies Regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in Relation to Good Manufacturing Practice (GMP) Guideline." Majalah Farmaseutik 17, no. 2 (2021): 243. http://dx.doi.org/10.22146/farmaseutik.v17i2.60237.

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There are some regulatory bodies in the world that impacting the pharmaceutical industry to operate and perform Good Manufacturing Practice (GMP) principles. These regulatory bodies exist to ensure that the pharmaceutical product and other human supporting products have a high standard of quality, safety, and efficacy from product registration to product distribution to the patient. This article reviews some aspects which is regulated by two of regulatory entities including Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) in relation with Good Manufacturing Practice (
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Elsafty, Ashraf, and Mohamed Osman. "The Impact of COVID-19 on the Efficiency of Packing Lines in Pharmaceutical Manufacturing Sites in Egypt." International Journal of Business and Management 16, no. 7 (2021): 57. http://dx.doi.org/10.5539/ijbm.v16n7p57.

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Corona Virus Disease COVID-19 has significantly impacted the pharmaceutical manufacturing sector. Production Efficiency in pharmaceutical facilities is questionable to withstand the drastic conditions under which the drug manufacturing supply chains are. Overall Equipment Effectiveness (OEE) is a primary indicator of efficiency. The aim of this review is to demonstrate a comprehensive overview on the factors impacting OEE and how they are affected by COVID-19.
 
 This review was done on a multinational pharmaceutical manufacturing facility in Egypt. In order to better understand the
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Latysheva, E. A., T. V. Latysheva, and I. A. Martynova. "Evaluation of efficacy and safety of intravenous immunoglobulin IG VENA in patients with primary antibody synthesis immunodeficiency." Russian Journal of Allergy 13, no. 1 (2016): 16–22. http://dx.doi.org/10.36691/rja364.

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Replacement immunotherapy with intravenous immunoglobulin (IVIG) has been used successfully for the treatment of primary immunodeficiency (PID) for over 60 years. During this time, a huge step forward in purification and manufacturing methods has been made. In addition IVIG therapy has been approved for other diseases and this number is steadily expanding causing an appearance of new IVIG on the pharmaceutical market. These drugs vary in composition, manufacturing technology and, as a consequence, in safety, administration rate, and efficacy. The new IVIG on the Russian market IG Vena was rece
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Bano, Gabriele, Riccardo De-Luca, Emanuele Tomba, Agnese Marcelli, Fabrizio Bezzo, and Massimiliano Barolo. "Primary Drying Optimization in Pharmaceutical Freeze-Drying: A Multivial Stochastic Modeling Framework." Industrial & Engineering Chemistry Research 59, no. 11 (2020): 5056–71. http://dx.doi.org/10.1021/acs.iecr.9b06402.

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9

Shim, Hyunjin, and Hongkee Sah. "Qualification of Non-Halogenated Organic Solvents Applied to Microsphere Manufacturing Process." Pharmaceutics 12, no. 5 (2020): 425. http://dx.doi.org/10.3390/pharmaceutics12050425.

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As a non-halogenated dispersed solvent, ethyl acetate has been most commonly used for the manufacturing of poly-d,l-lactide-co-glycolide (PLGA) microspheres. However, ethyl acetate-based microencapsulation processes face several limitations. This study was aimed at proposing ethyl formate as an alternative. Evaluated in this study was the solvent qualification of ethyl formate and ethyl acetate for microencapsulation of a hydrophobic drug into PLGA microspheres. An oil-in-water emulsion solvent extraction technique was developed to load progesterone into PLGA microspheres. Briefly, right after
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10

Oluwadare, Oreofe Praise, Omoniyi Joseph Ola-Olorun, and Billy Adegbola Oluwale. "Assessment of Total Quality Management Adoption Level in Pharmaceutical Manufacturing Companies in Southwestern Nigeria." International Journal of Engineering Research in Africa 43 (June 2019): 168–77. http://dx.doi.org/10.4028/www.scientific.net/jera.43.168.

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The objective of this study was to assess the adoption level of Total Quality Management (TQM) in pharmaceutical manufacturing industry in Southwestern Nigeria by a cross-sectional survey of staff in Lagos, Ogun and Oyo States of Nigeria involving 348 of the 2,649 members, selected by multi-stage sampling. Primary data were collected using a set of pre-tested semi-structured questionnaire which sought to elicit information on the level of TQM adoption and designed with items on a Likert–type scale of seven alternative responses with weighting scores of 0 through 6, representing seven stages (l
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11

Mishra, Devendra Kumar, and Shubham Shukla. "A Concept of Process Validation in Pharmaceutical Industries." International Journal of Innovative Science and Research Technology 5, no. 6 (2020): 1427–31. http://dx.doi.org/10.38124/ijisrt20jun1073.

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The aim of the article is to provide a brief presentation and general review on the criticalness of technical support of the pharmaceutical collecting strategy to ensure the security and minimization of the microbial turn of events. The process validation in the manufacturing unit is highly important to verify the surety at each and every stage of production. The microbial danger to aseptically created things in pharmaceutical clean rooms can be reviewed by the use of significant conditions that model the dispersing, move and explanation of microbial contamination, and the usage of numerical c
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12

Mocchi, Michela, Elia Bari, Giorgio Marrubini, et al. "Freeze-Dried Mesenchymal Stem Cell-Secretome Pharmaceuticalization: Optimization of Formulation and Manufacturing Process Robustness." Pharmaceutics 13, no. 8 (2021): 1129. http://dx.doi.org/10.3390/pharmaceutics13081129.

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Producing mesenchymal stem cell (MSC)-secretome for dose escalation studies and clinical practice requires scalable and good manufacturing practice (GMP)-compliant production procedures and formulation into a standardized medicinal product. Starting from a method that combines ultrafiltration and freeze-drying to transform MSC-secretome into a pharmaceutical product, the lyosecretome, this work aims to: (i) optimize the lyosecretome formulation; (ii) investigate sources of variability that can affect the robustness of the manufacturing process; (iii) modify the ultrafiltration step to obtain a
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13

Baula, O. P., O. O. Saliy, O. O. Shevchenko, and T. O. Shevchenko. "The risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of in-bulk finished products." Management, economy and quality assurance in pharmacy, no. 1(65) (March 15, 2021): 4–13. http://dx.doi.org/10.24959/uekj.21.1.

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Aim. To determine the areas of the risk-based approach to the development and implementation of the pharmaceutical quality system with the emphasis on the production of in-bulk finished products, identify the main factors affecting the stability of the functional characteristics of drugs in order to provide their compliance with the international quality standards, Good Manufacturing Practice and quality risk management. Results. 29 pharmaceutical companies with the license in Ukraine for dispensing and packing of medicines from in-bulk products have been identified. The control strategy for t
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14

Nemchenko A. S., Nazarkina V. M., Lebedyn A. M., and Podkolzina M. V. "ANALYSIS OF THE STATE OF THE SUPPLY OF UKRAINIAN POPULATION WITH CHONDROPROTECTIVE MEDICATIONS." International Academy Journal Web of Scholar, no. 1(43) (January 31, 2020): 43–50. http://dx.doi.org/10.31435/rsglobal_wos/31012020/6886.

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 Conduct systematic analysis of the state of the supply of Ukraine with medications with chondroprotective activity. The Unified Clinical Protocol of Primary, Secondary (specialized) Medical Care allows doctors to control the state of a patient at every stage of illness and guarantees the effective treatment and prophylaxis of the locomotor system (LMS) pathologies.As a result of the chondroprotective medication range analysis it was determined that the pharmaceutical market of Ukraine is represented by 40 trade names of medications. The top market share of chondropr
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15

Paranhos, Julia, Fernanda Steiner Perin, Eduardo Mercadante, and Caroline Soares. "Industry-university interaction strategies of large Brazilian pharmaceutical companies." Management Research: Journal of the Iberoamerican Academy of Management 17, no. 4 (2019): 494–509. http://dx.doi.org/10.1108/mrjiam-11-2018-0884.

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Purpose The purpose of this paper is to analyze the strategies and organizational forms used by large Brazilian pharmaceutical companies (LBPCs) in interaction with universities for the development of innovation. Design/methodology/approach In the pharmaceutical industry, a science-based sector, the source of new knowledge is often outside the company environment. Thus, the search for innovation depends on the company’s strategic decisions of cooperation. This research uses the case study method, with secondary data from the 2008, 2011 and 2014 Innovation Survey (Pintec) about the innovative e
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16

Olefir, Yu V., A. Yu Khubieva, E. L. Kovaleva, L. I. Mit’kina, A. A. Struzhkova, and E. V. Savin. "Quality Control of Ethyl Alcohol Used as a Medicinal Product." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 10, no. 1 (2020): 6–18. http://dx.doi.org/10.30895/1991-2919-2020-10-1-6-18.

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The manufacturing process, the source (raw materials), and primary packaging materials dictate requirements for the quality of ethyl alcohol used in the pharmaceutical industry.The aim of the paper was to analyse how the quality of ethyl alcohol used as a component of medicinal products depends on the starting materials, production method and technology, intended use, and the choice of the primary packaging. The paper analyses available information on ethyl alcohol quality and summarises data on potential impurities associated with the ethyl alcohol production technology and the starting mater
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17

OAMEN, Theophilus Ehidiamen. "effects of COVID-19 Pandemic on the Psyche and Productivity of Pharmaceutical Sales Workforce in an African Country; A descriptive case study." Advances in Social Sciences Research Journal 8, no. 5 (2021): 586–604. http://dx.doi.org/10.14738/assrj.85.10161.

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Pharmaceutical sales representatives are a pivotal workforce in the healthcare system. Due to the global impact of COVID-19, the impact on the psyche and morale of the pharmaceutical sales workforce has to be examined. The primary objective of the study was to assess the possible impact of the COVID-19 pandemic on the psyche and productivity of the pharmaceutical sales workforce in Nigeria. A questionnaire-guided cross-sectional survey was used to collect data from pharmaceutical sales personnel across the six geopolitical zones in Nigeria using purposive sampling. The final sample was 225. St
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18

Garcia-Perez, Laura, Anita Ordas, Kirsten Canté-Barrett, et al. "Preclinical Development of Autologous Hematopoietic Stem Cell-Based Gene Therapy for Immune Deficiencies: A Journey from Mouse Cage to Bed Side." Pharmaceutics 12, no. 6 (2020): 549. http://dx.doi.org/10.3390/pharmaceutics12060549.

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Recent clinical trials using patient’s own corrected hematopoietic stem cells (HSCs), such as for primary immunodeficiencies (Adenosine deaminase (ADA) deficiency, X-linked Severe Combined Immunodeficiency (SCID), X-linked chronic granulomatous disease (CGD), Wiskott–Aldrich Syndrome (WAS)), have yielded promising results in the clinic; endorsing gene therapy to become standard therapy for a number of diseases. However, the journey to achieve such a successful therapy is not easy, and several challenges have to be overcome. In this review, we will address several different challenges in the de
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Safina, D. D., and L. E. Ziganshina. "Statins and primary prevention of cardiovascular diseases: is there any point?" Kazan medical journal 94, no. 6 (2013): 924–32. http://dx.doi.org/10.17816/kmj1821.

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Increased blood cholesterol level is one of the most studied risk factors for cardiovascular diseases. While benefits of statins in secondary prevention are shown, their role in primary prevention is not clear. To assess the potential benefits of statin use in primary prevention of cardiovascular diseases, we searched databases for published data in English language for secondary analyses of clinical trials of statin use in primary prevention of cardiovascular diseases. The data on clinical outcomes were extracted to calculate the ratio of beneficial effect to no effect (benefit/no effect rati
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20

Peñaloza, Evelyn, Carla Holandino, Claudia Scherr, et al. "Comprehensive Metabolome Analysis of Fermented Aqueous Extracts of Viscum album L. by Liquid Chromatography−High Resolution Tandem Mass Spectrometry." Molecules 25, no. 17 (2020): 4006. http://dx.doi.org/10.3390/molecules25174006.

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Fermented aqueous extracts of Viscum album L. are widely used for cancer treatment in complementary medicine. The high molecular weight compounds viscotoxins and lectins are considered to be the main active substances in the extracts. However, a vast number of small molecules (≤1500 Da) is also expected to be present, and few studies have investigated their identities. In this study, a comprehensive metabolome analysis of samples of fermented aqueous extracts of V. album from two host tree species (Malus domestica and Pinus sylvestris), both prepared by two pharmaceutical manufacturing process
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21

Prajapati, Jignesh, and Darshit Patel. "Generic Drug User Fee Act II: The positive features for generic drug industry." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 13, no. 4 (2017): 206–13. http://dx.doi.org/10.1177/1741134317713800.

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The US Food and Drug Administration (FDA) and the Generic Drug Industry have completed negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA II). The agreement is now with Congress, which must write it into legislation in order for it to become effective. GDUFA II addresses questions that arose with the implementation of GDUFA I. One of the primary concerns with GDUFA I was that it did not provide any relief for small business whereas GDUFA II addresses relief for small business. GDUFA II has carved out a subcategory for Contract Manufacturing Organizations (CMOs), which
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Britz, Margaret. "A tribute to Professor Arnold L Demain – a lifetime in industrial microbiology." Microbiology Australia 31, no. 2 (2010): 97. http://dx.doi.org/10.1071/ma10097.

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Professor Arnold (Arny) Lester Demain is one of the few scientists who have witnessed the progress of biotechnology in a career that has spanned almost 60 years. He is one of the world?s leading industrial microbiologists who has pioneered discovery in genetic and nutritional regulation of biosynthetic pathways leading to overproduction of a suite of primary and secondary metabolites, and their subsequent scale-up in manufacturing processes. These metabolites have huge economic value due to their application in the food, pharmaceutical and agricultural sectors. In this article, Arny?s story is
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23

Robnik, Likozar, Wang, Stanić Ljubin, and Časar. "Understanding and Kinetic Modeling of Complex Degradation Pathways in the Solid Dosage Form: The Case of Saxagliptin." Pharmaceutics 11, no. 9 (2019): 452. http://dx.doi.org/10.3390/pharmaceutics11090452.

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Drug substance degradation kinetics in solid dosage forms is rarely mechanistically modeled due to several potential micro-environmental and manufacturing related effects that need to be integrated into rate laws. The aim of our work was to construct a model capable of predicting individual degradation product concentrations, taking into account also formulation composition parameters. A comprehensive study was done on active film-coated tablets, manufactured by layering of the drug substance, a primary amine compound saxagliptin, onto inert tablet cores. Formulation variables like polyethylen
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Zeeshan, Farrukh, Thiagarajan Madheswaran, Manisha Pandey, and Bapi Gorain. "Three-Dimensional (3-D) Printing Technology Exploited for the Fabrication of Drug Delivery Systems." Current Pharmaceutical Design 24, no. 42 (2019): 5019–28. http://dx.doi.org/10.2174/1381612825666190101111525.

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Background: The conventional dosage forms cannot be administered to all patients because of interindividual variability found among people of different race coupled with different metabolism and cultural necessities. Therefore, to address this global issue there is a growing focus on the fabrication of new drug delivery systems customised to individual needs. Medicinal products printed using 3-D technology are transforming the current medicine business to a plausible alternative of conventional medicines. Methods: The PubMed database and Google scholar were browsed by keywords of 3-D printing,
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Erkan, D., O. Unlu, S. Sciascia, et al. "Hydroxychloroquine in the primary thrombosis prophylaxis of antiphospholipid antibody positive patients without systemic autoimmune disease." Lupus 27, no. 3 (2017): 399–406. http://dx.doi.org/10.1177/0961203317724219.

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Objective The objective of this study was to determine the efficacy of hydroxychloroquine (HCQ) in the primary thrombosis prevention of antiphospholipid antibody (aPL)-positive patients with no other systemic autoimmune diseases. Methods Under the auspices of Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking, a multicenter, international, randomized controlled trial (RCT) was initiated, in which persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases were randomized to receive HCQ or no treatment in addition to their standar
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Sajonz, Peter, Theresa K. Natishan, Yan Wu, Neil T. McGachy, and David DeTora. "Development and Validation of a Sensitive and Robust Wipe‐Test Method for the Detection and Quantification of the Antibiotic Ertapenem and its Primary Degradates in a Pharmaceutical Manufacturing Environment." Journal of Liquid Chromatography & Related Technologies 28, no. 5 (2005): 713–25. http://dx.doi.org/10.1081/jlc-200048892.

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Anju, ,., and Ghazala Javed. "Sharbat- E- Unnab: A Review on Potent Unani Formulation." Journal of Drug Delivery and Therapeutics 11, no. 3-S (2021): 142–44. http://dx.doi.org/10.22270/jddt.v11i3-s.4836.

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Unani System of Medicine is also known as Greco-Arabic medicine, and developed into an elaborate scientific medical system by Arab and Persian physicians, such as Rhazes (850-925AD), Avicenna (980-1037AD), Al-Zahrawi and Ibn Nafis. It is practiced in India since eighth century AD and is a recognized Indian traditional system of medicine with good infrastructure for education; research and manufacturing unitswhich are well regulated by the Government. In Unani medicine there are well developed pharmacopeia and pharmaceutical processings for single & compound formulations for the treatment o
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Grupp, Stephan A., Theodore W. Laetsch, Jochen Buechner, et al. "Analysis of a Global Registration Trial of the Efficacy and Safety of CTL019 in Pediatric and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)." Blood 128, no. 22 (2016): 221. http://dx.doi.org/10.1182/blood.v128.22.221.221.

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Abstract A single-center trial of CD19 directed, lentiviral transduced chimeric antigen receptor (CAR) T cells (CTL019) for relapsed and refractory (r/r) B-ALL pediatric patients showed rates of CR >90% with prolonged CAR T cell persistence/CR without further therapy in the majority of patients infused (Maude NEJM 2014). We report here the feasibility, safety and efficacy of the first multicenter global pivotal registration CAR T cell trial. Features of this trial include: i) the first trial in which industry-manufactured cells were provided to all patients; ii) enrollment across 25 centers
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Jain, Achin, Venkatesh M. P., Raja Mohan Reddy.G, and Pramod Kumar T.M. "REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 62–74. http://dx.doi.org/10.22270/ijdra.v3i1.158.

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The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug regis
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Zulkiflee, Izzat, and Mh Busra Fauzi. "Gelatin-Polyvinyl Alcohol Film for Tissue Engineering: A Concise Review." Biomedicines 9, no. 8 (2021): 979. http://dx.doi.org/10.3390/biomedicines9080979.

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The field of biomaterials has been steadily expanding as a large number of pharmaceutical and manufacturing companies invest in research in order to commercialize biomaterial products. Various three-dimensional biomaterials have been explored including film, hydrogel, sponge, microspheres etc., depending on different applications. Thus, gelatin and polyvinyl alcohol (PVA) are widely used as a natural- and synthetic-based biomaterial, respectively, for tissue engineering and clinical settings. The combination of these materials has proven its synergistic effects in wound-healing applications. T
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Pang, Eric, William Chong, and Markham C. Luke. "Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon." Journal of the Endocrine Society 5, Supplement_1 (2021): A324—A325. http://dx.doi.org/10.1210/jendso/bvab048.662.

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Abstract Glucagon for Injection (NDA 020928) is a polypeptide hormone identical to human glucagon approved 20 years ago for severe hypoglycemia in patients with diabetes mellitus. On Dec 28, 2020, the U.S. FDA approved the first generic version of glucagon for injection USP, 1 mg/vial packaged in an emergency kit. The generic and the reference listed drug (RLD) version, i.e., the innovator version, of glucagon were each produced through different manufacturing processes. The RLD version of glucagon is produced via recombinant DNA in yeast while the generic version of glucagon is produced by pe
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Alawattegama, Kingsley Karunaratne. "The Impact of the Adoption of Enterprise Risk Management on the Industrial Financial Performance." International Journal of Research in Business and Social Science (2147-4478) 6, no. 6 (2017): 9–20. http://dx.doi.org/10.20525/ijrbs.v6i6.815.

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Enterprise risk management (ERM) has gained an increased attention during the recent past as an integrated approach to manage risk for creating and preserving firm value. The objective of this study is to explore and empirically verify as to whether the adoption of the ERM has an impact on the firm performance. This study uses both primary and secondary data pertaining to 129 companies listed on the Colombo Stock Exchange under the banking & finance, insurance, diversified, manufacturing, food and beverage and chemical and pharmaceutical sectors. Primary and secondary data are collected by
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Bobrovs, Raitis, Līga Mitriķe, and Andris Actiņš. "The solvent effect on the crystal morphology of two tegafur polymorphs." Acta Crystallographica Section A Foundations and Advances 70, a1 (2014): C1687. http://dx.doi.org/10.1107/s2053273314083120.

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Pharmaceutical compounds are mostly produced in defined crystalline forms that are usually crystallized from solutions. Polymorphs, different crystalline phases of the same pharmaceutical compound, usually have different, precisely known dissolution rates and bioavailability, but crystal size and shape can affect these properties. Therefore, the crystal shape is monitored during the drug manufacturing process and a lot of work in the area of crystal engineering has been devoted to crystal habit control [1]. The crystallization solvent can have a significant effect on the resulting crystal shap
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Mora Román, Juan José, Natalia Agüero Brenes, Camila Angulo Morales, et al. "Physicochemical and Microbiological Assays for Quality Evaluation of a Brand of Mentha piperita Tisanes in Costa Rica Market: Employment of the Central American Technical Regulation." Journal of Drug Delivery and Therapeutics 8, no. 5 (2018): 329–37. http://dx.doi.org/10.22270/jddt.v8i5.1878.

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Mentha piperita is a natural hybrid of water mint (Mentha aquatica) and spearmint (Mentha spicata L.), that are consumed as tisanes. For that reason, the present work evaluated physicochemical and microbiological aspects for the quality control of a commercial brand of Mentha piperita herbal tea distributed in Costa Rica, using assays established by the Central American Technical Regulation (RTCA) 11.03.56.09 (Pharmaceutical products. Natural medicinal products for human use. Quality verification), and determined if they have uniformity for different batches of this brand. To verify the qualit
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Naseem, Raasti, Charalampos Tzivelekis, Matthew J. German, Piergiorgio Gentile, Ana M. Ferreira, and Kenny Dalgarno. "Strategies for Enhancing Polyester-Based Materials for Bone Fixation Applications." Molecules 26, no. 4 (2021): 992. http://dx.doi.org/10.3390/molecules26040992.

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Polyester-based materials are established options, regarding the manufacturing of bone fixation devices and devices in routine clinical use. This paper reviews the approaches researchers have taken to develop these materials to improve their mechanical and biological performances. Polymer blending, copolymerisation, and the use of particulates and fibre bioceramic materials to make composite materials and surface modifications have all been studied. Polymer blending, copolymerisation, and particulate composite approaches have been adopted commercially, with the primary focus on influencing the
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Jacques, Emmanuel Reginald, and Paschalis Alexandridis. "Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps." Applied Sciences 9, no. 15 (2019): 3066. http://dx.doi.org/10.3390/app9153066.

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Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users. Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose and is an emerging concept in the pharmaceutical industry. The primary reason for the tablet scoring practice is to adjust the dose: dose tapering or dose titrating
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Nelson, Jeffrey, Richard Moravec, Dun Li, Jennifer Wilkinson, Frank Fan, and Mei Cong. "843 Reproducible, MoA-reflecting reporter-based bioassays to enable drug development of biosimilars and biobetters." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (2020): A895. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0843.

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BackgroundCytokines and growth factors are small immunomodulatory proteins secreted by a wide variety of cells (e.g. fibroblasts, endothelial and stromal cells) that regulate surrounding cells via autocrine, paracrine or endocrine mechanisms. Immunocytokines are a promising class of activators of the immune system, with the potential to be used alone or in combination with other therapeutic agents to treat a variety of disease including autoimmunity and cancer. This class of biologics includes FDA-approved cytokine therapies (e.g. IFN, IL-2 and Epo) as well as an increasing number of biologics
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38

Duchesne, Luc C., and Suzanne Wetzel. "The bioeconomy and the forestry sector: Changing markets and new opportunities." Forestry Chronicle 79, no. 5 (2003): 860–64. http://dx.doi.org/10.5558/tfc79860-5.

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The bioeconomy is expected to replace the current information economy and will depend heavily on the manufacturing and trade of bioproducts, which are all commodities generated by living organisms through the use of technology and biotechnology, as well as non-timber forest products. In Canada alone, markets for bioproducts are in excess of $100 billion annually. The bioeconomy should impact most of Canada's economic sectors: energy and transportation, food and agro-food, pharmaceuticals, nutraceuticals, forestry, materials and manufacturing, waste management and a large variety of consumer go
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39

Husain, Uvesh, Sarfaraz Javed, and Aisha Salim Al Araimi. "A STUDY OF FOREIGN DIRECT INVESTMENT ON MANUFACTURING INDUSTRIES IN SULTANATE OF OMAN." International Journal of Research -GRANTHAALAYAH 9, no. 3 (2021): 1–9. http://dx.doi.org/10.29121/granthaalayah.v9.i3.2021.3696.

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The objective of this research is to find impact of foreign direct investment on manufacturing industries in Oman. The study utilized a quantitative research method which applied primary and secondary data obtained from Oman's World Bank database (1984-2018). The primary data were collected from a research questionnaire administered to 410 respondents from nine industrial sectors, namely: Textile, Petroleum goods, Electronics, Automotive, Food & Beverages, Agriculture & Fishery, Publishing, Chemicals and Pharmaceutics. The results of this study also revealed that the spillover impacts
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40

Maude, Shannon L., Michael A. Pulsipher, Michael W. Boyer, et al. "Efficacy and Safety of CTL019 in the First US Phase II Multicenter Trial in Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia: Results of an Interim Analysis." Blood 128, no. 22 (2016): 2801. http://dx.doi.org/10.1182/blood.v128.22.2801.2801.

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Abstract Background: CTL019 is an investigational therapy derived from autologous T-cells expressing a CD19-specific chimeric antigen receptor (CAR). A single center, phase I/IIa trial of CTL019 showed complete and durable remissions in pediatric/young adult patients (pts) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) (Maude et al NEJM 2014); these results have yet to be reproduced in a multicenter setting. Here, we report results from a 6-month interim analysis of the first multicenter phase II trial of an engineered cell therapy in leukemia. Methods: 9 US sites p
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41

Locatelli, Franco, Mark C. Walters, Janet L. Kwiatkowski та ін. "Lentiglobin Gene Therapy for Patients with Transfusion-Dependent β-Thalassemia (TDT): Results from the Phase 3 Northstar-2 and Northstar-3 Studies". Blood 132, Supplement 1 (2018): 1025. http://dx.doi.org/10.1182/blood-2018-99-112667.

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Abstract Background Transfusion-dependent β-thalassemia (TDT) is a severe genetic disease caused by impaired β-globin production, leading to severe anemia, lifelong transfusion dependence with iron overload and serious comorbidities. Gene therapy (GT) offers a potentially transformative option for these patients. LentiGlobin GT contains autologous CD34+ hematopoietic stem cells (HSCs) transduced ex vivo with the BB305 lentiviral vector (LVV) encoding β-globin with a T87Q substitution. The safety and efficacy of LentiGlobin in patients with TDT was assessed in the phase 1/2 Northstar study in w
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42

Pouya, Pascal, Aziz Khayati, and Kamal Chatouane. "Growth Sectors in Morocco and Investment Potential: A Quantitative Analysis." International Journal of Economics and Finance 13, no. 10 (2021): 54. http://dx.doi.org/10.5539/ijef.v13n10p54.

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During the 1990s Morocco implemented a series of major institutional and economic reforms that made the country politically stable and helped it to withstand the destabilizing effects of the Arab Spring. Political reforms resulted in the adoption of a new constitution in 2011, was followed by initiatives to improve justice, public administration, the fight against corruption, and to strengthen governance, transparency, and ethics in public life. The country also embarked on a regionalization of public policies and decentralization of administration to ensure an integrated and durable regional
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43

Esoimeme, Ehi Eric. "A critical analysis of the effects of the Central Bank of Nigeria foreign exchange policy on financial inclusion, anti-money laundering measures and fundamental rights." Journal of Money Laundering Control 20, no. 4 (2017): 417–27. http://dx.doi.org/10.1108/jmlc-05-2016-0020.

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Purpose Following the drop in crude oil prices from a peak of US$114 per barrel in July 2014 to as low as US$33 per barrel in January 2016, the country’s reserves have suffered great pressure from speculative attacks, round tripping and front loading activities by actors in the foreign exchange (forex) market. The fall in oil prices also implied that the Central Bank of Nigeria’s (CBN) monthly foreign earnings had fallen from as high as US$3.2bn to current levels of as low as US$1bn. The net effect of these combined forces unfortunately is the depletion of the nation’s forex reserves. As of Ju
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44

Lamb, Lawrence S., Melissa Jo Beelen, Samantha Langford Youngblood, Rupal Soder, Sunil Abhyankar та Joseph P. McGuirk. "First-in-Human Phase I Trial of Adoptive Immunotherapy with Ex Vivo Expanded and Activated Γδ T Cells Following Haploidentical Bone Marrow Transplantation and Post-BMT Cyclophosphamide". Blood 136, Supplement 1 (2020): 9. http://dx.doi.org/10.1182/blood-2020-142876.

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INTRODUCTION: HAPLO BMT combined with cyclophosphamide infusion on days +3 and +4 following BMT (PTCy) for patients that lack an HLA-matched donor provides effective graft versus host disease (GVHD) prophylaxis but with a heightened risk of disease recurrence likely due to prolonged immunodeficiency. Multiple studies have shown that increases in circulating donor-derived gamma delta (γδ) T cells during the early post-transplant period is strongly associated with significant improvement in disease-free survival (DFS). We developed a clinical protocol to engineer this effect by infusing escalati
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Marin-Garcia, Juan A., Pilar I. Vidal-Carreras, Julio J. Garcia Sabater, and Javier Escribano-Martinez. "Protocol: Value Stream Maping in Healthcare. A systematic literature review." WPOM-Working Papers on Operations Management 10, no. 2 (2019): 36. http://dx.doi.org/10.4995/wpom.v10i2.12297.

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<p>Until 2016, very few works had investigated the use of the VSM. With this research, we will discover if the situation has changed in the last 3 years. In the lean manufacturing context, different techniques that help the continuous improvement process can be used (Marin-Garcia & Bonavia, 2011; Marin-Garcia & Carneiro, 2010; Marin-Garcia et al., 2012; Scott, 2001). One is the Value Stream Map (VSM) (Coetzee et al., 2016; Marin-Garcia & Mateo Martínez, 2013; Vidal-Carreras et al., 2015). This publication is a protocol (Marin-Garcia, 2015; Marin-Garcia, 2019) that
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46

Walenga, Jeanine, Walter Jeske, Sabrina Bertini, et al. "Bovine Heparin Demonstrates the Same Interaction with HIT Antibodies As Porcine Heparin." Blood 134, Supplement_1 (2019): 2351. http://dx.doi.org/10.1182/blood-2019-127304.

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Heparin, an anticoagulant widely used in numerous medical applications, is considered an essential medicine by the WHO. Due to its high volume use and that it is the parent material for low molecular weight heparins, there is potential for the raw material to be in short supply. The African swine fever epidemic in China, ongoing since August 2018, has added further restraints on heparin source material supply. At present medical grade heparin in the US is only derived from porcine intestinal mucosa; however, there are explorations into using bovine, ovine, and other sources. Bovine heparin, on
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47

Grupp, Stephan A., Shannon L. Maude, Susana Rives, et al. "Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia." Blood 132, Supplement 1 (2018): 895. http://dx.doi.org/10.1182/blood-2018-99-112599.

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Abstract BACKGROUND Tisagenlecleucel is an FDA approved chimeric antigen receptor (CAR)-T cell therapy that reprograms T cells to eliminate CD19+ B cells. ELIANA (NCT02435849) is a phase 2 pivotal study of tisagenlecleucel in pediatric/young adult patients (pts) with CD19+ r/r B-cell acute lymphoblastic leukemia (ALL), the first global trial of a CAR-T cell therapy. The primary objective was met, with an overall remission rate (ORR) of 81% (complete remission [CR] + CR with incomplete blood count recovery [CRi]). Here we present an update of ELIANA, with additional pts and additional 11 mo fol
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48

Kwiatkowski, Janet L., Alexis A. Thompson, John E. J. Rasko та ін. "Long-Term Clinical Outcomes of Lentiglobin Gene Therapy for Transfusion-Dependent β-Thalassemia in the Northstar (HGB-204) Study". Blood 134, Supplement_1 (2019): 4628. http://dx.doi.org/10.1182/blood-2019-125807.

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Background Patients with transfusion-dependent β-thalassemia (TDT) may experience transfusional iron overload and end-organ damage. While potentially curative, allogeneic hematopoietic stem cell (HSC) transplantation is limited by transplant-related risks and donor availability. Transplantation of autologous CD34+ cells encoding a βA-T87Q-globin gene (LentiGlobin gene therapy for β-thalassemia) may overcome some of these limitations. βA-T87Q-globin is incorporated into adult hemoglobin (Hb), forming gene therapy-derived HbAT87Q, which can be distinguished from other Hb species. The phase 1/2 N
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49

Frydrych, Barbara, Elżbieta Bruchajzer, and Jadwiga Szymańska. "Quinoline. Documentation of proposed values of occupational exposure limits (OELs)." Podstawy i Metody Oceny Środowiska Pracy 34, no. 1(95) (2018): 53–71. http://dx.doi.org/10.5604/01.3001.0011.5827.

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Quinoline is a colorless hygroscopic liquid with a pungent odor. It darkens with age. It is soluble in alcohol, ether, benzene and carbon disulfide, and is slightly soluble in water. It is used as a solvent and a decarboxylation reagent, and as a raw material in manufacturing dyes, antiseptics, fungicides, niacins and pharmaceuticals. The occupational exposure to quinoline applies to a person involved in the production of the substance or using products manufactured from this substance. The primary routes of potential human exposure to quinoline are ingestion, inhalation, and dermal contact. T
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50

Park, Jae H., Nitin Jain, Andy Chen, et al. "A Phase I Study of FT819, a First-of-Kind, Off-the-Shelf, iPSC-Derived TCR-Less CD19 CAR T Cell Therapy for the Treatment of Relapsed/Refractory B-Cell Malignancies." Blood 136, Supplement 1 (2020): 15–16. http://dx.doi.org/10.1182/blood-2020-142423.

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Background: Autologous T cells engineered to express a chimeric antigen receptor (CAR) targeting the B-cell lineage antigen CD19 (CAR19) in patients with relapsed/refractory (r/r) aggressive B-cell lymphomas (BCL) and pre-B acute lymphoblastic leukemia (B-ALL) have resulted in transformative improvements in clinical outcomes. However, there remain significant limitations concerning autologous CAR19 T cell manufacturing, including dysfunctional starting material, lack of product consistency and purity following genetic engineering, manufacturing timelines that necessitate the administration of
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