Strength biowaiver [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2018-02-25 14:20 (2309 d 00:38 ago) – Posting: # 18461
Views: 4,473

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.

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