Rubrik: GMP / GLP / GCP
(Treffer aus pharmind, Nr. 11, Seite 1481 (2019))
Buschmann H | Handler N
How to conduct successful forced degradation studies – Scope and regulatory requirements / Part II*Part I of this article see Pharm. Ind. 2019;81(9):1192–1196. · Buschmann H, Handler N · RD&C Research, Development & Consulting GmbH, Vienna und , Austria
Forced degradation conditions represent the exposure of a drug substance (DS) or drug product (DP) to stress conditions more severe than accelerated conditions which result in relevant degradation products. Well-designed and -applied forced degradation is a useful tool in predicting drug stability, which is an essential critical parameter and has an impact on purity, potency, and safety of the DP. For instance, changes in drug stability may result in a decrease of the active substance or the formation of toxic degradation products. Currently, several guidelines provide general recommendations and guidance on forced degradation studies, but none of the guidelines gives ...