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RegisterICH M9 - reverse engineering? [Regulatives / Guidelines]
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
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
Complete thread:
- ICH M9 - reverse engineering? MSimoes 2020-09-16 16:01 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M9 - reverse engineering? dshah 2020-09-17 06:46
- ICH M9 - reverse engineering? MSimoes 2020-09-17 15:56
- ICH M9 - reverse engineering?dshah 2020-09-30 07:27
- ICH M9 - reverse engineering? MSimoes 2020-09-17 15:56
- ICH M9 - reverse engineering? dshah 2020-09-17 06:46
Ing. Helmut Schütz