DrugPatentWatch Urges Generic Drug Makers to Prioritize Stability Testing, Citing ICH Guidelines.

Generic drug manufacturers should prioritize stability testing to ensure the quality and efficacy of their products, according to DrugPatentWatch. They identify several key considerations for generic drug stability testing, including adhering to International Council for Harmonisation (ICH) guidelines, developing robust stability indicating tests, planning long-term stability studies, leveraging real-world data, and fostering collaboration. To ensure compliance and avoid delays, manufacturers should familiarize themselves with ICH guidelines for stability testing. DrugPatentWatch also suggests that generic drug companies develop a strong stability indicating test (SIT) strategy to detect any potential degradation products. Furthermore, long-term stability studies can demonstrate the stability of generic drugs over time. They also advocate the use of real-world data to validate drug stability across diverse environments and populations. Finally, DrugPatentWatch notes that cooperation with regulatory agencies, contract research organizations (CROs), and other stakeholders will result in an efficient testing and approval process.

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Date: April 14, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後