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Artykuły w czasopismach na temat „Efficacy and quality of the drug product”

Autor: Grafiati

Data publikacji: 2 czerwca 2025

Data aktualizacji: 31 lipca 2025

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1

Yamuna, Choudhary, Goyal Anju, and Vaishnav Rajat. "Process Validation of Solid Dosage Form." Pharmaceutical and Chemical Journal 7, no. 1 (2020): 46–54. https://doi.org/10.5281/zenodo.13952198.

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Process validation is an essential part for the safety of drug products and also to maintain the quality of the products. It is a fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to ensure the identity, purity, safety, and efficacy of drug products. The process validation precisely focused on the aim and method of analysis. The Process validation reduces product recalls and troubleshooting assignments which results in more economical manufacturing process and quality products. In this article an overview is given on

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Mannan, Abdul, and Hajera Mubeen. "DIGITALISATION AND AUTOMATION IN PHARMACEUTICALS FROM DRUG DISCOVERY TO DRUG ADMINISTRATION." International Journal of Pharmacy and Pharmaceutical Sciences 10, no. 6 (2018): 1. http://dx.doi.org/10.22159/ijpps.2018v10i6.24757.

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The rapid progress in the pharmaceutical industry is due to the advancement in the digitalization and automation starting from the invention to the administration of the drug. Every advancement in the development of the pharmaceutical product is associated with progress in digitalization. A drug or a drug product to be administered safely and to provide efficacy it has to undergo a long journey from its discovery, including pre-clinical and clinical trials to further product development in the research and development. The production and manufacturing systems with appropriate digitalization an

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Aziz-Andersen, Kaiser Jay. "Biosimilar Biologic Drugs: A Systematic Approach to Development, Manufacturing and Clinical Applications." Journal of Drug Delivery and Therapeutics 10, no. 6 (2020): 191–94. http://dx.doi.org/10.22270/jddt.v10i6.4373.

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This publication addresses biosimilar biologic drugs development and future innovations. Emphasis is placed on quality system approaches to the development and availability of new biosimilar drug products presented in premarket applications. For approvals of new biosimilars, the sponsors of premarket applications must present analytical and biological characterization to demonstrate that a proposed biosimilar drug is highly similar to the licensed reference product. The premarket application protocol requires a sponsor to describe the biosimilar product’s PK/PD clinical data comparing its safe

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Alkesh, S. Mourya, and Rajesh Kumar Pandey Dr. "A Study on Factors Attributed to Failure of Pharmaceutical Products." Applied Science and Biotechnology Journal for Advanced Research 3, no. 2 (2024): 12–21. https://doi.org/10.5281/zenodo.10976869.

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The Pharmaceutical Industry plays a pivotal role in healthcare by developing, manufacturing, and marketing drugs to treat a myriad of medical conditions. However, despite rigorous research, development, and testing processes, a significant number of pharmaceutical products fail to meet the expected standards or gain market acceptance. This study aims to explore the multifaceted factors that contribute to the failure of pharmaceutical products, focusing on the product life cycle as a framework for analysis. The product life cycle of a pharmaceutical product encompasses several stages, including

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Khan, Rana Muhammad Awais, and Mubashar Rehman. "Quality Determination (In-process & Finished product Quality Testing Parameters) of Triamcinolone Acetonide Injectable Suspension." Global Drug Design & Development Review III, no. I (2018): 23–30. http://dx.doi.org/10.31703/gdddr.2018(iii-i).04.

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Triamcinolone acetonide is an antiinflammatory drug that has been used for more than 50 years for the treatment of various inflammatory disorders including the arthritis & gout etc. Moreover, in recent years its use has been rapidly increased for the treatment of retinal vasculature disease and Uveitis, periocular and intraocular treatment. This review summarizes the whole manufacturing process of this formulation along with the complete in-process QC & Finished dosage form test parameters that ensures the efficacy and safety of this drug. Furthermore, the industrial requirements in th

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Swapnil, Khopade* Dr. Deepak Kardile Aniket Mohite Dr. Vishwas Bhagat Tushar Shinde Dr. Rajkumar Shete Vaibhavi Kunjir. "The Role of Stability-Indicating RP-HPLC In Ensuring Drug Product Quality and Shelf Life." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 3509–31. https://doi.org/10.5281/zenodo.15115168.

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Reverse-phase high-performance liquid&ensp;chromatography (RP-HPLC) is commonly employed in pharmaceutical analysis for the isolation and quantification of drugs, impurities, and degradation products. Ensuring the quality of drug products and the shelf life—determined by the potency, safety, and efficacy of a particular drug—is an important assessment that is carried out through stability studies, where environmental variables such&ensp;as temperature, humidity, and storage conditions are tested to see how they affect the drug over time. Stability-indicating RP-HPLC method is one o

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Ganesh, U. Chavan* Vitthal R. Gawade1 Vaibhav P. Chopade2 Shubham V. Wankhede Sahil D. Nivangune3 Dattatray B. Gatade4. "Review On Drug Stability." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 954–65. https://doi.org/10.5281/zenodo.11214813.

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This includes drug stability studies Important parameters for new drugs and new drug development pharmaceutical formulation. Durability prediction plays a big role All dosage forms and their drug development Helps determine and suggest storage conditions for each Label description. Ensuring drug stability research Maintain product quality, safety and effectiveness throughout Durability is a prerequisite for acceptance Drug approval. These studies are necessary It will be implemented according to the guidelines issued by ICH. WHO or other institution Stability is crucial to the process of devel

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Kishor, S. Arote* Darshan A. Salade Nilesh V. Patil. "A Brief Review on Regulatory Affairs: Ensuring Compliance, Safety, and Market Access." International Journal in Pharmaceutical Sciences 1, no. 10 (2023): 22–30. https://doi.org/10.5281/zenodo.8397986.

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This review paper provides a comprehensive analysis of the field of regulatory affairs, offering insights into its historical evolution, current challenges, emerging trends, and future directions. Regulatory affairs play a pivotal role across various industries in ensuring compliance with laws and regulations, maintaining product quality, and safeguarding public health and safety. Drug regulatory affairs are an important part of the pharmaceutical industry. As usual the pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry f

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Abdul Wadood Ansari, Arti, Ashish Kumar Yadav, Abhisek Yadav, Mohd Mushaid, and Tanya Singh. "Pharmaceutical packaging innovations: enhancing drug safety, efficacy, and patient compliance: A brief review." World Journal of Biology Pharmacy and Health Sciences 22, no. 3 (2025): 072–87. https://doi.org/10.30574/wjbphs.2025.22.3.0466.

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In the pharmaceutical sector, packaging plays a significant role in the development of different drug formulations. An essential component that protects the pharmaceutical substance is the packaging. Maintaining the quality of pharmaceuticals during storage, delivery, transit, and sale is dependent on the product's quality. Product containment, ease of use, and compliance during storage, transportation, display, and consumption. the stability of medicine solid, liquid, gel or paste form depend on packing material to prevent drug from chemical degradation. There are three levels of classificati

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Gogna, Kunal. "Regulatory aspects of Impurity profiling." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 45–54. http://dx.doi.org/10.22270/ijdra.v8i4.433.

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Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines o

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Jezdimirovic, Milanka, Vitomir Cupic, Sasa Ivanovic, Blagoje Dimitrijevic, and Nemanja Jezdimirovic. "Factors that affect therapeutic efficacy and safety of drugs." Veterinarski glasnik 69, no. 5-6 (2015): 401–15. http://dx.doi.org/10.2298/vetgl1506401j.

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According to the Law on medicines and medicinal devices, veterinary drugs must be of high quality, efficacy and safety to be suitable for use on animals. However, there are numerous factors which can alter the intensity of drugs and their established therapeutic efficacy and safety. These factors may depend on the patients themselves i.e. animals (species, age, sex, physiological state, impaired functions of organs involved in the elimination of drugs, diseases of other organ systems, nutrition, genetic disorders, individual variations, tolerance etc.), veterinary surgeons (use of the drug whi

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Boers, Maarten. "A new design for registration trials in rheumatoid arthritis allowing secondary head-to-head comparisons with standard of care treatment including biologicals: Figure 1." Annals of the Rheumatic Diseases 69, no. 01 (2009): 4–6. http://dx.doi.org/10.1136/ard.2009.110007.

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Current drug development programs produce high quality data on the efficacy of new drugs, substantial data on safety, but little data on actual applicability of the new product compared to standard of care. After successful registration and launch, such data require years to accumulate and often remain incomplete.This viewpoint proposes a new trial design for phase 2 and 3 drug trials in rheumatoid arthritis. In this design the trial starts conventionally: patients that are inadequate responders to standard treatment (usually methotrexate) are randomised to receive the experimental drug or pla

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Ashutosh Kumar Yadav, Abhishek Yadav, Manish Yadav, Md Akhlak, Shweta Mishra, and Jitendra Kumar Rai. "A review on drug stability." International Journal of Science and Research Archive 9, no. 1 (2023): 474–85. http://dx.doi.org/10.30574/ijsra.2023.9.1.0424.

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Stability is crucial to the process of developing new drugs. Stability studies are regarded as a must for the acceptance and approval of any pharmaceutical product since they guarantee the stability of product quality, safety, and efficacy during the shelf life. This article will reduce the knowledge gap on the most important aspect for researcher or a developer who is developing a formulation by providing a complete information about drug stability, principle of drug degradation, Force degradation studies, Stability studies and their Classification, Factor Affecting Stability of Drug, Mechani

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Ahmad, Iqbal, Sofia Ahmed, Zubair Anwar, Muhammad Ali Sheraz, and Marek Sikorski. "Photostability and Photostabilization of Drugs and Drug Products." International Journal of Photoenergy 2016 (2016): 1–19. http://dx.doi.org/10.1155/2016/8135608.

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Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups important for the photoreactivity of drugs, explains photophysical processes, and deals with the kineti

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15

Hichem, NAAS, MEHENNAOUI Sarra, and GHARBI Abdelaziz. "Characterization of biosimilars: Description of the analytical approach." GSC Biological and Pharmaceutical Sciences 25, no. 2 (2023): 215–21. https://doi.org/10.5281/zenodo.10609734.

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Biological drugs stand out from chemically synthesized drugs by their complexity. The latter puts developers, manufacturers, and controllers of drugs facing really scientific and technological challenges to ensure a safe, effective, and high-quality product. Regulatory agencies evaluate biosimilars based on their level of similarity to the innovative drug, rather than their exact resemblance to it. The recommendations of the Food and Drugs Administration indicate that, when evaluating the product, “The totality of the evidence” will be considered. With the aim of providing access t

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Badjatya, Jitendra Kumar, and Ramesh Bodla. "DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET." International Journal of Drug Regulatory Affairs 1, no. 2 (2018): 1–6. http://dx.doi.org/10.22270/ijdra.v1i2.3.

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There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research &

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Bandarapalle, Kishore, Rajasekhar Komarla Kumarachari, Kamasani Teja Sri, et al. "A Review on regulatory affairs and regulatory requirements for drug approval." Future Journal of Pharmaceuticals and Health Sciences 4, no. 1 (2024): 26–38. http://dx.doi.org/10.26452/fjphs.v4i1.550.

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Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t

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Bandarapalle, Kishore. "A Review on regulatory affairs and regulatory requirements for drug approval." A Review on regulatory affairs and regulatory requirements for drug approval 4, no. 1 (2024): 26–38. https://doi.org/10.5281/zenodo.14650148.

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Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t

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G., Raja Mohan Reddy, M. P. Venkatesh, Achin J., and Pramod Kumar T.M. "REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA." International Journal of Drug Regulatory Affairs 2, no. 2 (2018): 7–15. http://dx.doi.org/10.22270/ijdra.v2i2.126.

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Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and ar

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Badjatya, Jitendra Kumar, Anil Jangid, Prakash Dodiya, et al. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 10, no. 1 (2022): 51–82. http://dx.doi.org/10.22270/ijdra.v10i1.510.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Associatio

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Patel, Preeti, Jitendra Kumar Badjatya, and Madhuri Hinge. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 7, no. 3 (2019): 48–62. http://dx.doi.org/10.22270/ijdra.v7i3.350.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Associatio

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Amal, Kumar, Arvind Kumar Dr., and Saini Rajat. "STANDARDIZATION OF HERBAL DRUG FOENICULAM VULGARE." International Journal of Education & Applied Sciences Research 9, no. 1 (2022): 39–48. https://doi.org/10.5281/zenodo.7074322.

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<strong>ABSTRACT</strong> <em>The procedure of standardising herbal preparations is a key aspect of obtaining the product's quality and efficacy, and it is the rate-limiting stage in Ayurvedic formulations. The data about the concentrations employed in the formulation are provided in detail by the procedure. In this study, standardization of herbal drugs- Foeniculum vulgare was investigated. The formulary of ayurvedic drugs in India was followed in the production. For the standardisation of commercial and in-house ayurvedic medicinal products, the organoleptic qualities, physical propertie

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Brandi, Maria Luisa. "Biosimilars open up new opportunities in chronic diseases." International Journal of Bone Fragility 1, no. 1 (2021): 34–37. http://dx.doi.org/10.57582/ijbf.210101.034.

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The World Health Organization defines a biosimilar product as a biotherapeutic that is similar in terms of quality, safety and efficacy to an already licensed reference product available on the market. To ensure similar efficacy and safety, comparability studies for biosimilars should be carried out at quality, preclinical and clinical level. In this article we provide an overview of biosimilars, looking at the definition of the term biosimilar, the regulatory framework and the future prospects for these drugs. As biosimilar drugs will revolutionize the treatment of osteoporosis, this paper ai

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Ashok Kumar P, Renu GM, Suhas S Gowda, Tejaswini HU, Vinay Kumar, and Yashwanth HN. "Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 404–9. http://dx.doi.org/10.30574/wjarr.2023.20.1.2056.

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Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on history, regulatory policy and organization, and re

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Ashok, Kumar P., GM Renu, S. Gowda Suhas, HU Tejaswini, Kumar Vinay, and HN Yashwanth. "Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 404–9. https://doi.org/10.5281/zenodo.12186280.

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Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on history, regulatory policy and organization, and re

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Harshada, Sandeep Jadhav*, Anil Salunkhe Pratiksha, Maniraj Yadav Sunil, and Shoheb Shaikh Dr. "REGULATORY AFFAIRS IN THE PHARMACY MODULES." World Journal of Pharmaceutical Science and Research 3, no. 6 (2024): 207–23. https://doi.org/10.5281/zenodo.14576264.

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The pharmaceutical industry plays a crucial role in regulatory affairs, ensuring the safety, efficacy, and quality of drugs, protecting human health, promoting consumer trust, and supporting innovation. Key terms include Active Pharmaceutical Ingredient (API), New Drug Application (ANDA), Clinical Trials, Good Manufacturing Practice (GMP), International Council for Harmonisation (ICH), Investigational New Drug (IND), New Drug Application (NDA), Orphan Drug, Pharmacovigilance, and Post-Marketing Surveillance. Regulatory Authorities like the FDA, EMA, and MHRA regulate drugs and have standard op

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Tyski, Stefan, Magdalena Burza, and Agnieszka Ewa Laudy. "Microbiological Contamination of Medicinal Products —Is It a Significant Problem?" Pharmaceuticals 18, no. 7 (2025): 946. https://doi.org/10.3390/ph18070946.

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Medicinal products available on the market should be characterised by therapeutic efficacy, high quality, and safety for patients. They must either be sterile or comply with the appropriate pharmacopoeial microbiological purity requirements. Pharmacopoeial monographs related to microbiological tests of drug quality were also referenced. Despite stringent regulations governing pharmaceutical production, irregularities in the microbiological quality of drugs still occur. These are monitored by relevant agencies, which may order the recall of defective product batches from the market. However, in

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Li, Sicong, Fang Liu, Kai Zhang, Yujia Tong, and Xin Liu. "Research Progress on the Mechanism of Natural Product Ingredients in the Treatment of Uveitis." Journal of Immunology Research 2021 (July 16, 2021): 1–9. http://dx.doi.org/10.1155/2021/6683411.

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As the spectrum of ophthalmic diseases keeps changing, uveitis has gradually become one of the major blinding eye diseases in the world. Although the efficacy and safety of adalimumab and other biological agents in the treatment of uveitis have been proved in clinical studies, no biological agents have been approved for the treatment of uveitis by Chinese National Medical Products Administration (NMPA). The quality of life and prognosis of uveitis patients are affected by the adverse reactions of currently available immunosuppressive drugs. In recent years, it has become a research hotspot to

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Patel, Krima H., Neeta Banzal, Sadhana K. Hingorani, and Anupama Desai. "A study of awareness of generic drugs amongst residents and intern doctors in a tertiary care hospital in Surat city." International Journal of Basic & Clinical Pharmacology 14, no. 3 (2025): 362–66. https://doi.org/10.18203/2319-2003.ijbcp20251061.

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Background: As defined by WHO generic drug is “a pharmaceutical product which is intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights”. They are made with the same active substance as the non-generic drugs which are already authorized and approved for their safety, efficacy and quality before getting licensed. Methods: A cross-sectional, prospective, questionnaire-based study was conducted on 115 residents and intern doctors. Awareness and knowledge a

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Prashik, Chopade*, Satpute Siddhant, and Kamble Roshan. "REAL TIME DRUG STABIITY MONITORING IN PACKAGING MATERIAL." World Journal of Pharmaceutical Science and Research 4, no. 2 (2025): 981–93. https://doi.org/10.5281/zenodo.15303308.

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Real-time drug stability assessment utilizes non-invasive techniques to evaluate the quality of pharmaceutical products without opening their packaging. Methods such as Infrared (IR) and Ultraviolet (UV) spectroscopy, along with temperature monitoring via embedded non-invasive sensors, enable the detection of chemical or physical changes in the drug. These spectroscopic techniques are particularly effective in distinguishing between expired and stable formulations, offering critical insights into drug integrity and potency. The primary advantage of real-time monitoring is its ability to ensure

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Sreelekha, Salevendula, K. Vinod Kumar, Nawaz Mahammed, et al. "Quality by Design Approaches in Pharmaceutical Development and Solid Dosage Forms Production: A Narrative Overview." Jordan Journal of Pharmaceutical Sciences 16, no. 4 (2023): 770–84. http://dx.doi.org/10.35516/jjps.v16i4.908.

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Quality by Design (QbD) is an essential approach to pharmaceutical development and manufacturing that has garnered significant attention in recent years. Quality in services, products, and procedures equates to customer satisfaction. Consequently, it facilitates a transition in the pharmaceutical sector and the Food and Drug Administration (FDA) toward a more scientific, risk-based, comprehensive, and proactive drug development strategy. The pharmaceutical industry is actively seeking new solutions to ensure product quality and efficiency. This paper provides a comprehensive overview of QbD pr

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Ponamarev, V. S. "Quality management in bioequivalence assessment: problems and prospects." Issues of Legal Regulation in Veterinary Medicine, no. 2 (July 8, 2022): 98–101. http://dx.doi.org/10.52419/issn2782-6252.2022.2.98.

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One of the main problems of modern drug production is the assessment of bioequivalence during the life cycle of the product at the stage of preliminary approval (the stage of clinical trials) and at the stage after approval.Getting a biowaiver is very important for pharmaceutical companies because of the significant savings in resources and time. However, if this is not done with scientific justification, safety and efficacy may be affected due to false positive decisions. Often differences in bioavailability are not found in pharmaceutical practice and hence are rarely reported.A search of or

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Rumel, Dey, and Roy Chowdhury Dona. "Review of Pharmaceutical Solid Polymorphism: Preparation, Characterization and Influence on Performance of Drugs." Journal of Advances in Bio- pharmaceutics and Pharmacovigilance 2, no. 1 (2020): 33–48. https://doi.org/10.5281/zenodo.3668629.

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<em>When the crystalline structure of the same chemical compound (and atomic formula) exhibits two or more patterns of the repeated unit cells, these crystalline structures are called polymorphs and the phenomena is referred to as polymorphism. Active pharmaceutical ingredient (API) can have a variety of polymorph. These different Polymorphic forms of drug substance exhibits different physical and chemical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapor pressure and density. Polymorphism properties of API

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Yamaguchi, Teruhide, and Eriko Uchida. "Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies." Current Cancer Drug Targets 18, no. 2 (2018): 202–8. http://dx.doi.org/10.2174/1568009617666170222142650.

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Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product. Since oncolytic viruses exhibit prolonged persistence in patients, viral shedding and transmission to third parties should be major concerns for clinical trials along with the clinical safety and efficacy. Accordingly, studies are now underway to establish the safety and eff

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P., Patel* S. Solanki B. Vihol. "An Industry Perspective: How To Develop Analytical Method For Related Substances Of Drug Product By Applying A QbD." International Journal in Pharmaceutical Sciences 2, no. 2 (2024): 360–79. https://doi.org/10.5281/zenodo.10673264.

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Related substances is one of the most important analytical test, which defines the quality, safety & efficacy of product by monitoring the growth of impurities in drug product. Knowledge about related substances at early phase of development helps to decide the storage condition and container closure system for finished product Development of robust and rugged analytical method for estimation of these impurities is challenging task for analytical scientist due to complex nature of formulation matrix. The main objective of this review article is to provide a systematic way to develop stabil

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Renish, S. Pethani* Dr. Maitreyi Zaveri Dr. Niranjan Kanaki. "Comparative Post Approval Changes Requirement Of Pharmaceutical Drug Product And Drug Substance In USA And Canada." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 138–43. https://doi.org/10.5281/zenodo.12609178.

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This article presents a comparative examination of the post-approval changes requirements governing pharmaceutical drug products and drug substances in the United States (USA) and Canada. Regulatory frameworks in both countries are crucial for ensuring the safety, efficacy, and quality of pharmaceuticals while facilitating innovation and access to healthcare. the research methodology involves a thorough examination of relevant guidelines, regulations, and case studies from both countries. Key factors such as the types of changes, submission requirements, approval processes, and timelines will

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Samata, Korgaonkar* Gauri Bhivshet Vijay Jagtap. "An Overview of Transdermal Drug Delivery System (TDDS)." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 2132–42. https://doi.org/10.5281/zenodo.14482112.

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Oral medications often fall short of desired efficacy. To address this limitation, transdermal drug delivery systems (TDDS) have emerged as a viable alternative. TDDS involve delivering drugs through the skin to achieve systemic effects, differing from traditional topical applications. These systems transport drugs to viable skin tissues, producing local therapeutic effects while also releasing a significant fraction into systemic circulation. The adhesive used in TDDS plays a crucial role in ensuring product safety, efficacy, and quality. Transdermal delivery offers several advantages over tr

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Han, Jianlin, Alicja Wzorek, Gagan Dhawan, et al. "CHIRAL, FLUORINE-CONTAINING PHARMACEUTICALS." Ukrainian Chemistry Journal 91, no. 2 (2025): 55–90. https://doi.org/10.33609/2708-129x.91.2.2025.55-90.

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Fluorine is a key element in drug design due to its ability to enhance metabolic stability, binding affinity, and bioavailability. Fluorine’s properties lead to more stable drugs with longer half-lives, reducing dosing frequency and improving patient compliance. Its small size and high electronegativity also improve binding affinity, resulting in more effective treatments with lower doses. For example, fluorine increases a compound’s ability to cross cell membranes. This article highlights advancements in chiral, fluorine-containing pharmaceuticals introduced over the past five years, focusin

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Kumar, Ajay, Surya Prabhakar Singh, Shashi Pratap Singh, and Nirmal Morya. "FORMULATION AND CHARACTERIZATION OF HERBAL SHAMPOO FOR ANTI-DANDRUFF BASED ON LIQUID FORMULA." International Journal of Pharma Professional’s Research (IJPPR) 14, no. 1 (2023): 6–14. http://dx.doi.org/10.48165/ijppronline.2023.14102.

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The main object of this present study is to prepare and evaluate an herbal shampoo and determine physiochemical function that emphasizes on safety, efficacy and quality of the product Herbal Shampoo is the natural hair-care product which is use to remove grease, dirt, dandruff and promote hair growth, strength ness and darkness of the hair. Various drugs are used for the preparation of cosmetics shampoo. Such drug shows various side effects such as hair loss, increased scaling, scratching, nausea and headache. Therefore, an attempt is made to formulate herbal shampoo that is free from side eff

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Polskiy, Vsevolod S., Aleksey A. Reznichenko, Svetlana N. Vodyanitskaya, Roman V. Shcherbinin, and Мarya S. Gurova. "PHARMACOLOGICAL EFFICACY OF LIPOFOS IN HEPATOSIS OF LAYING HENS." Problems of veterinary sanitation, hygiene and ecology 2, no. 50 (2024): 261–66. http://dx.doi.org/10.36871/vet.san.hyg.ecol.202402013.

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Fats and oils are one of the most important components of compound feed for poultry. Their importance is determined by the ability to accumulate energy in the body, as lipids are structural components of biological membranes. Therefore, it is necessary to use lipid feed additives and phospholipid preparations. Optimal doses of the phospholipid preparation – lipofos, a by-product of soy lecithin production, have been established for laying hens. Hepatoprotective properties of the studied drug were established, which are manifested by the restoration of the histostructure of bird liver cells. An

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Hemamalini, Saravanan K. L. Senthil Kumar. "Formulation And Evaluation Of Medicated Chewing Gum Containing Metformin And Glimepiride." International Journal of Pharmaceutical Sciences 2, no. 4 (2024): 503–20. https://doi.org/10.5281/zenodo.10943964.

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The formulation and evaluation of MCG containing a combination of anti-diabetic drugs is a critical endeavor in pharmaceutical research, aiming to enhance drug efficacy and patient compliance in managing diabetes mellitus. Combining anti-diabetic drugs in a single formulation offers potential advantages such as synergistic effects, improved glycemic control and simplified dosing regimens. Micro-crystalline cellulose, a widely used pharmaceutical excipients, can serve as an ideal matrix for such formulations due to its inert nature, high surface area and excellent compressibility properties. Th

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K. Raghuram Reddy, S. Sunayana, and K. Usha. "Procedure And Regulations For Drug Registration In UK." International Journal of Pharmaceuticals and Health Care Research 12, no. 4 (2024): 317–28. https://doi.org/10.61096/ijphr.v12.iss4.2024.317-328.

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MHRA (Medicines And Health Products Regulatory Agency) is the regulatory authority body for pharmaceuticals approval in the UK union. MHRA is formed by the merging of two separate agencies in 2003 i.e., Medicines Control Agency and Medical Device Agency. This agency works to maintain safety, quality and efficacy of the drug product before it enters into the country. The main aim of this work is to know about the practice and the regulatory requirements for the registration of a drug in the UK as per the regulations of MHRA. They are responsible for ensuring that the medicines and medical devic

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Hichem NAAS, Sarra MEHENNAOUI, and Abdelaziz GHARBI. "Characterization of biosimilars: Description of the analytical approach." GSC Biological and Pharmaceutical Sciences 25, no. 2 (2023): 215–21. http://dx.doi.org/10.30574/gscbps.2023.25.2.0482.

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Biological drugs stand out from chemically synthesized drugs by their complexity. The latter puts developers, manufacturers, and controllers of drugs facing really scientific and technological challenges to ensure a safe, effective, and high-quality product. Regulatory agencies evaluate biosimilars based on their level of similarity to the innovative drug, rather than their exact resemblance to it. The recommendations of the Food and Drugs Administration indicate that, when evaluating the product, “The totality of the evidence” will be considered. With the aim of providing access to cheaper tr

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Gupta, Rajkumar. "FACTS ON DRUG REGULATIONS." International Journal of Drug Regulatory Affairs 2, no. 3 (2018): 43–47. http://dx.doi.org/10.22270/ijdra.v2i3.140.

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The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of dr

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Semenova, K. M., and L. Almakaieva. "Substantiation of the target quality profile and risk assessment in the development of a combined drug for injection." News of Pharmacy 103, no. 1 (2022): 79–85. http://dx.doi.org/10.24959/nphj.22.89.

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Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk factors affecting the quality of the combined drug for injections at the stage of pharmaceuticaldevelopment (PD). Materials and methods. The study objects were the active pharmaceutical ingredients (АРІ) of SH, DHQ and a drug in the form of a solution for injection based on them, as well as potential risk factors affecting the quality of the p

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Soni, G. R. "Overview of non-innovator biological products in India." Generics and Biosimilars Initiative Journal 9, no. 1 (2020): 30–36. http://dx.doi.org/10.5639/gabij.2020.0901.006.

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As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to its classification as a ‘non-innovator’ biological, which are approved as ‘New Drugs’. According to the World Health Organization (WHO), these biological products have uncertain safety and efficacy when compared to the r

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Sharma, Shrey, R. B. Bodla, Shweta S., and D. P. Pathak. "PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM: A REVIEW." International Journal of Drug Regulatory Affairs 2, no. 3 (2018): 67–78. http://dx.doi.org/10.22270/ijdra.v2i3.144.

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ICH is “International Conference on Harmonization” of technical requirements for registration of pharmaceuticals for human use. The goal of ICH is to discuss and establish common guidelines by bringing together three ICH regions i.e. USA, Japan and EU and to make information available on ICH, its activities and guidelines. The guidelines have become more relevant for Generic’s Drug Approval. Drug Development and manufactures are more and more global. Harmonization is considered more important than ever, as it facilitates work sharing, efficient use of resources and access to medicines. The obj

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A, Vaishnavi. "Review on Regulator’s Perspective of TGA about Pharmacovigilance during Premarketing and Post Marketing of Medicinal Product." Advances in Pharmacology & Clinical Trials 9, no. 3 (2024): 1–7. http://dx.doi.org/10.23880/apct-16000249.

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The Review is about Therapeutic Goods Administration (TGA) which is a regulatory authority responsible for ensuring the safety, quality, and efficacy of therapeutic goods in Australia and how it works during the premarketing and post marketing of medicinal products. It clearly explains about the responsibilities of TGA in evaluation of drug safety data during pre-marketing and post-marketing phases, the implementation of risk management plans, and the facilitation of effective communication channels for adverse event reporting.

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Suryawanshi, Dr Amrata D. "Transdermal Drug Delivery System." International Journal for Research in Applied Science and Engineering Technology 11, no. 10 (2023): 858–62. http://dx.doi.org/10.22214/ijraset.2023.56109.

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Abstract: A various non-invasive administration have recently emerged as an alternative toconventional needles. Transdermal drug delivery system is most attractive method. The transdermal as route has numerous advantages over the more traditional drug delivery system and they include high bioavailability, absence offirst pass hepatic metabolism, steady drug plasma concentration. and the fact that therapy is noninvasive. TDDS could be applicable in not only Pharmaceuticals but also in the skin industry, including cosmetics. Transdermal drug delivery has made an important contribution to medical

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V, Sreekala, Dwivedi K. N, and Santosh Kumar Singh. "New Drug Development strategies with special reference to the endocarp of multifaceted agriculture crop – Cocos nucifera Linn." JOURNAL OF ADVANCED APPLIED SCIENTIFIC RESEARCH 4, no. 4 (2022): 19–24. http://dx.doi.org/10.46947/joaasr442022447.

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Coconut shell botanically represents the hard endocarp from the fruit of Cocos nucifera Linn. It is the usually discarded part of the plant with folklore claim in metabolic disorders.Being an inexpensive and easily availablenatural product with ethno medicinal significance, it seems highly relevant to scientifically validate the pharmaceutical implications of the drug. Till date, the new drug development strategies based on quality and efficacy parameters for the crude drug sample of Coconut shell has not been developed. The present study was intended to develop and scientifically validate the

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