Different comparator batches [Regulatives / Guidelines]

posted by jansari  – India, 2025-07-10 19:40 (346 d 02:42 ago) – Posting: # 24409
Views: 3,870

Hi,

Kindly help me out for following question::

Is the use of a single batch of comparator product in Bioequivalence study mandatory or we can use multiple batches ?
If any regulatory guidance please share the guidance docs..

Quick response is highly appreciated…

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