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RegisterStrength biowaiver [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2018-02-25 14:20 (2249 d 17:04 ago) – Posting: # 18461
Views: 4,334
Hi powell,
I suggest:
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.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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
Complete thread:
- biowaiver-acceptable dissolution&proportional similarity powell 2018-02-25 09:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strength biowaiverHelmut 2018-02-25 13:20
- Strength biowaiver giang nidqc 2018-08-22 13:01
- Strength biowaiver JMCardot 2018-08-24 19:44
- Strength biowaiver giang nidqc 2018-08-22 13:01
- Strength biowaiverHelmut 2018-02-25 13:20
Ing. Helmut Schütz