Type-II Variation: Waive in-vivo study by providing in-vitro data? [Study As­sess­ment]

posted by qualityassurance – 2024-07-02 13:29 (325 d 09:09 ago) – Posting: # 24054
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Dear Helmut,

Thank you for the response.

Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size?

Regards,
QA

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