制药开发和固体制剂生产中的设计质量方法:叙述性概述

Q3 Pharmacology, Toxicology and Pharmaceutics Jordan Journal of Pharmaceutical Sciences Pub Date : 2023-12-25 DOI:10.35516/jjps.v16i4.908
Salevendula Sreelekha, Vinod Kumar, N. Mahammed, T. Reshma, U. Sree, Shakir Basha, M. Bhuvaneswari
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引用次数: 0

摘要

质量源于设计(QbD)是近年来备受关注的药品研发和生产的重要方法。服务、产品和程序的质量等同于客户满意度。因此,它促进了制药行业和食品药品管理局(FDA)向更科学、更基于风险、更全面和更积极主动的药物开发战略转型。制药行业正在积极寻求新的解决方案,以确保产品质量和效率。本文全面概述了 QbD 原则及其在制药行业的应用。本文讨论了实施 QbD 原则的好处,包括提高效率、降低成本、改善产品质量、安全性和有效性。随着制药业的不断发展,QbD 仍将是药物开发和生产的一个重要方面。本文旨在让制药专业人士全面了解 QbD 方法。
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Quality by Design Approaches in Pharmaceutical Development and Solid Dosage Forms Production: A Narrative Overview
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 principles and their application in the pharmaceutical industry. The benefits of implementing QbD principles are discussed, encompassing increased efficiency, reduced costs, and improved product quality, safety, and efficacy. As the pharmaceutical industry continues to evolve, QbD will remain a crucial aspect of drug development and manufacturing. This article aims to provide pharmaceutical professionals with a comprehensive understanding of the QbD approach.
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来源期刊
Jordan Journal of Pharmaceutical Sciences
Jordan Journal of Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.70
自引率
0.00%
发文量
33
期刊介绍: The Jordan Journal of Pharmaceutical Sciences (JJPS) is a scientific, bi-annual, peer-reviewed publication that will focus on current topics of interest to the pharmaceutical community at large. Although the JJPS is intended to be of interest to pharmaceutical scientists, other healthy workers, and manufacturing processors will also find it most interesting and informative. Papers will cover basic pharmaceutical and applied research, scientific commentaries, as well as views, reviews. Topics on products will include manufacturing process, quality control, pharmaceutical engineering, pharmaceutical technology, and philosophies on all aspects of pharmaceutical sciences. The editorial advisory board would like to place an emphasis on new and innovative methods, technologies, and techniques for the pharmaceutical industry. The reader will find a broad range of important topics in this first issue.
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