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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

Author

Zuki Patel

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2 papers indexed here

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Open access Sep 2026

Decoding FDA Complete Response Letters: Regulatory Challenges and Strategies for Successful Drug Approval

It is highlighted that major deficiencies in USFDA drug approval submissions, particularly in CMC and clinical areas, are commonly associated with poor data quality, inadequate validation, incomplete documentation, and insufficient safety and efficacy evidence.

Mukti Kapdi, M. Zaveri, Zuki Patel et al. · 0 citations
Open access Sep 2026

Regulatory Trends and Challenges in Pharmaceutical Submissions: A Critical Analysis of Health Authority Requirements on Nitrosamine Impurities, Elemental Impurities, Forced Degradation and Genotoxicity

Comparing regulatory anticipations of impurity management within pharmaceutical submissions in terms of elements of nitrosamine impurities, genotoxic impurities, forced degradation, and elemental impurities shows that the compliance with harmonized ICH requirements and regulatory frameworks allows managing impurities r...

Darshan Mistry, Zuki Patel, Vinit Movaliya et al. · 0 citations

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