ICH M9 - reverse engineering? [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2020-09-30 07:27 (687 d 13:42 ago) – Posting: # 21951
Views: 723

Dear Marta!

Pls find the recent presentation by FDA on - From General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness. It can be downloaded from - https://sbiaevents.com/files2/Innov-2020-Day-1.zip and see- D1S14-Kozak. It will be useful for BCS based biowaiver approach as well.

Regards,
Dshah

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On two occasions I have been asked,—“Pray, Mr. Babbage,
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