Regulatory Experience with Continuous Manufacturing and Real Time Release Testing for Dissolution in New Drug Applications.

Autor: Kakhi, Maziar1 (AUTHOR) maziar.kakhi@fda.hhs.gov, Li, Jing2 (AUTHOR), Dorantes, Angelica2 (AUTHOR)
Zdroj: Journal of Pharmaceutical Sciences. Oct2023, Vol. 112 Issue 10, p2604-2614. 11p.
Databáze: Academic Search Ultimate