Bioequivalence and Bioavailability Forum • Strength biowaiver

Strength biowaiver [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2018-02-25 14:20 (2250 d 15:23 ago) – Posting: # 18461
Views: 4,337

Hi powell,

I suggest:

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.
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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

biowaiver-acceptable dissolution&proportional similarity powell 2018-02-25 09:49
- Strength biowaiverHelmut 2018-02-25 13:20
  - Strength biowaiver giang nidqc 2018-08-22 13:01
    - Strength biowaiver JMCardot 2018-08-24 19:44