Development of Mechanistic In Vitro–In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables.

Autor: Amaral Silva, Daniela1 (AUTHOR) daniela.silva@simulations-plus.com, Le Merdy, Maxime1 (AUTHOR) viera.lukacova@simulations-plus.com, Alam, Khondoker Dedarul2 (AUTHOR) khondoker.alam@fda.hhs.gov, Wang, Yan2 (AUTHOR) yan.wang3@fda.hhs.gov, Bao, Quanying3 (AUTHOR) bqy.pharm@gmail.com, Malavia, Nilesh3 (AUTHOR) nilesh.malavia@uconn.edu, Burgess, Diane3 (AUTHOR) d.burgess@uconn.edu, Lukacova, Viera1 (AUTHOR)
Zdroj: Pharmaceutics. Apr2024, Vol. 16 Issue 4, p552. 13p.
Databáze: Academic Search Ultimate
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