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  • 1Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd., Hyderabad, India.

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|January 6, 2026
PubMed

キーワード:
追加剤形生物学的同等性免除ICH M13ガイドライン即放性および放出制御製剤溶出類似性製剤比例性規制要件

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