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NK ☆ India, 2026-03-13 07:26 (82 d 23:20 ago) Posting: # 24592 Views: 1,389 |
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Dear All, Can a single bioequivalence study be conducted and the results used to support both an NDA (505(b)(2)) and an ANDA submission? For example, a three-way crossover study comparing Capsule [RLD], Capsule [Test], and Tablet [Test], where the Capsule [Test] is intended for the ANDA application and the Tablet [Test] is intended for the NDA submission. Regards NK |
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dshah ★★ India, 2026-03-18 07:01 (77 d 23:45 ago) @ NK Posting: # 24594 Views: 999 |
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Hello NK! Kindly go through ICH M13A section 2.2.3.1-general consideration ![[image]](img/uploaded/image272.jpg) Regards, Divyen |
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NK ☆ India, 2026-03-20 07:18 (75 d 23:28 ago) @ dshah Posting: # 24596 Views: 967 |
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Hi Divyen, Thanks for the reply. The discussed study is NDA-505b(2) and ANDA. As per ICH M13A, section 1.3 Scope These guidelines do not cover PK study design or data analysis to support BA assessment for new drug development in support of intended use or dosing recommendations in drug labelling, e.g., relative BA assessment, food effect, drug-drug interactions, special population studies, bridging formulations without the necessity to demonstrate BE, and studies to support changes in dosing regimens or routes of administration. Regards NK |
Ing. Helmut Schütz