Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui  – Germany, Oman, 2018-10-02 02:52 (987 d 01:01 ago) – Posting: # 19358
Views: 4,647

(edited by wienui on 2018-10-02 03:14)

Dear Amalia & Scopy,

I agree with Scopy only an important point to mention that the dissolution tests of the lower strength must be conducted against the same Biobatch (the batch which approved via BE study) of the higher strength, otherwise it will not be accepted from the regulatory.

Best regards,

Osama

Cheers,
Osama

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