分析方法最新趋势综述:发展战略和最新应用

Tanu Chaudhary, Akshay Kumar, N. Raj, GS Sarma, Shubham Dawange, Dilpreet Singh
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引用次数: 0

摘要

原料药分析在提高散装药物和药物制剂的质量、安全性、有效性和效力方面发挥着重要作用。在过去的几十年里,药物杂质、辅料分析以及生物制药溶出度和生物利用度测试方法的开发势在必行。此外,制药业的发展也需要更新技术,如分析质量设计(QbD)和人工智能。本综述侧重于分析方法开发及其由 ICH、US-FDA、AOAC 和 USP 等监管机构提供的官方指南。此外,本文还介绍了各种验证和系统参数及其适用性和推荐范围。还以科学的方式对用于执行各种原料药分析的分析技术进行了批判性评估。此外,还记录了制药业和研究领域的最新应用趋势。因此,这篇综述为读者提供了充足的信息,使他们能够从头开始深入了解开发分析方法的高级技术和制药行业的最新趋势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications
API analysis plays an important role in nourishing the quality, safety, efficacy, and potency of bulk drugs and pharmaceutical formulations. Increased drug products in the market lead to increased demand for new analytical techniques for Active Pharmaceutical Ingredient (API) analysis. During the past decades, method developments were necessitated for drug impurities, excipient profiling, and testing for biopharmaceuticals like dissolution and bioavailability. Moreover, advancements in the pharmaceutical industries necessitate upgrading newer technologies like analytical Quality by Design (QbD) and artificial intelligence. This review focused on analytical method development and its official guidelines provided by various regulatory bodies including ICH, US-FDA, AOAC, and USP. Moreover, this present art also states various validation and system parameters along with their applicability and recommended range. The critical appraisal of analytical technologies for performing various API analyses was also written in a scientific manner. Moreover, applications in recent trends in pharmaceutical industries as well as research were also documented. Hence, this review provides sufficient information for the readers for in-depth information starting from scratch to higher technologies for developing analytical methods and recent trends in the pharmaceutical industry.
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