Quality by Design Approach: Progress in Pharmaceutical method Development and Validation

Q3 Pharmacology, Toxicology and Pharmaceutics

Biomedical and Pharmacology Journal Pub Date : 2023-09-30 DOI:10.13005/bpj/2745

Avinash V. Chavan, R. Gandhimathi

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引用次数: 1

Abstract

Pharmaceutical analysis plays a significant role in pharmaceutical formulation quality assurance and control. Due to the pharmaceutical industries' rapid expansion and the production of pharmaceuticals all over the world, there is a greater need for novel analytical procedures in this sector. Establishing the identification, purity, physical properties, and potency of medications as well as the medication's bioavailability and stability is the goal of analytical method development. A few new drug applications were recently given regulatory flexibility by the Food and Drug Administration for an analytical method based on quality by design. With Quality by design, product design and development are performed methodically. Analytical methodologies have similar opportunities for implementing Quality by design as production procedures do. It consequently enhances formulation design, development efficiency, and capacity. The underpinnings of the QbD approach have been explored in this article due to their use in the creation and validation of analytical procedures. Additionally, a summary of experimental studies reporting the application of the QbD methodology to method development is included.

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设计质量:制药方法开发和验证的进展

药物分析在药物制剂质量保证和控制中起着重要的作用。由于制药工业的快速扩张和世界各地药品的生产，这一领域对新型分析方法的需求更大。建立药物的鉴定、纯度、物理性质和效力以及药物的生物利用度和稳定性是分析方法发展的目标。最近，美国食品和药物管理局对基于质量设计的分析方法给予了一些新药申请监管灵活性。通过设计实现质量，有条不紊地进行产品设计和开发。分析方法与生产程序一样，有类似的机会通过设计实现质量。因此，它提高了配方设计、开发效率和能力。本文探讨了QbD方法的基础，因为它们用于创建和验证分析过程。此外，还包括报告QbD方法在方法开发中的应用的实验研究摘要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Biomedical and Pharmacology Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

1.20

自引率

0.00%

发文量

189

期刊介绍： Biomedical and Pharmacology Journal (BPJ) is an International Peer Reviewed Research Journal in English language whose frequency is quarterly. The journal seeks to promote research, exchange of scientific information, consideration of regulatory mechanisms that affect drug development and utilization, and medical education. BPJ take much care in making your article published without much delay with your kind cooperation and support. Research papers, review articles, short communications, news are welcomed provided they demonstrate new findings of relevance to the field as a whole. All articles will be peer-reviewed and will find a place in Biomedical and Pharmacology Journal based on the merit and innovativeness of the research work. BPJ hopes that Researchers, Research scholars, Academician, Industrialists etc. would make use of this journal for the development of science and technology. Topics of interest include, but are not limited to: Biochemistry Genetics Microbiology and virology Molecular, cellular and cancer biology Neurosciences Pharmacology Drug Discovery Cardiovascular Pharmacology Neuropharmacology Molecular & Cellular Mechanisms Immunology & Inflammation Pharmacy.