不同药物剂型的方法开发与验证综述

Vaishnawi R. Bhagwat, Chetan M. Jain, Nitin I. Kochar, Krutika S. Sonar
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引用次数: 0

摘要

药物分析对于散装和制剂的质量控制至关重要。由于全球药物生产和制药行业的扩张,对创新分析方法的需求日益增长。目前,开发分析程序是分析工作中最重要的部分。分析仪器的改进催生了新的分析方法。分析方法和技术的改进缩短了分析时间,提高了精确度和准确性,降低了分析成本。因此,大多数制药企业都在专业分析实验室投入巨资。针对活性药物成分 (API)、辅料、药物产品、降解产品和相关物质、残留溶剂以及其他化学品的分析技术应运而生并得到验证。因此,它已成为监管组织标准的重要组成部分。分析方法的发展导致了官方测试方法的产生。质量控制实验室利用这些方法来验证药品的特性、纯度、安全性、有效性和性能。生产分析方法正与监管机构息息相关。监管机构希望申请者能够利用既定的分析方法证明对药物开发过程的控制。
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Review on method development and validation for different pharmaceutical dosage form
Pharmaceutical analysis is crucial for bulk and formulation quality control. Due to global medication manufacturing and pharmaceutical sector expansion, innovative analytical methods are in demand. Developing analytical procedures is now the most significant part of analysis. Improvements in analytical instruments have led to new analytical methods. The improvement of analytical methodologies and technologies has reduced analysis time, increased precision and accuracy, and decreased analysis costs. As a consequence, the majority of pharmaceutical businesses are investing heavily in specialist analysis labs. Analytical techniques for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, and other chemicals are created and verified. As a consequence, it has become an essential component of the regulating organization's standards. Development of analytical methodologies leads to official test methods. Quality control labs utilize these methods to verify drug identity, purity, safety, effectiveness, and performance. Production analytical methods are becoming relevant to regulators. Regulatory agencies expect applicants to demonstrate control of the drug development process using established analytical methodologies.
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