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Back to the forum  2018-07-22 07:45 CEST (UTC+2h)
powell
Junior

China,
2018-02-25 09:49

Posting: # 18460
Views: 986
 

 biowaiver-acceptable dissolution&proportional similarity [Dissolution / BCS / IVIVC]

Hello everyone, how to understand the two prerequisites for a biowaiver of additional strengths? :confused: can you present detailed cases? thanks.


Edit: Category changed; see also this post #1. [Helmut]
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-02-25 13:20

@ powell
Posting: # 18461
Views: 785
 

 Strength biowaiver

Hi powell,

I suggest:
  1. Cardot J-M, García-Arieta A, Paixão P, Taševská I, Davit B. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches. AAPS J. 2016;18(4):1039–46. doi:10.1208/s12248-016-9915-0.
  2. Cardot J-M, García-Arieta A, Paixão P, Taševská I, Davit B. Implementing the additional strength bio­waiver for generics: EMA recommended approaches and challenges for a US-FDA submission. Eur J Pharm Sci. 2018;111:399–408. doi:10.1016/j.ejps.2017.10.013.
Both papers contain case studies.

Cheers,
Helmut Schütz
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