Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Several regulatory guidelines exist for stabil...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English English English |
| Published: |
Elsevier B.V
2018
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/1/63353_Current%20regulatory%20requirements%20and%20practical.pdf http://irep.iium.edu.my/63353/7/63353_Current%20regulatory%20requirements%20and%20practical%20approaches_scopus.pdf http://irep.iium.edu.my/63353/13/63353_Current%20regulatory%20requirements%20and%20practical%20approaches%20for%20stability%20analysis%20of%20pharmaceutical%20products_WoS.pdf |