Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective.
Zelesky T, Baertschi SW, Foti C, Allain LR, Hostyn S, Franca JR, Li Y, Marden S, Mohan S, Ultramari M, Huang Z, Adams N, Campbell JM, Jansen PJ, Kotoni D, Laue C.
Zelesky T, et al.
J Pharm Sci. 2023 Dec;112(12):2948-2964. doi: 10.1016/j.xphs.2023.09.003. Epub 2023 Sep 9.
J Pharm Sci. 2023.
PMID: 37690775
Review.
These two endpoints are 1) a % total degradation target outcome (e.g., for "reactive" drugs) or, 2) a specified amount of stress, even in the absence of any degradation (e.g., for "stable" drugs). ...The experimental data set, derived from the Campbell et al. (20 …
These two endpoints are 1) a % total degradation target outcome (e.g., for "reactive" drugs) or, 2) a specified amount of stress, eve …