title: The role of degradant profiling in active pharmaceutical ingredients and drug products.
abstract: Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. In order to fulfill development and regulatory needs, this publication provides a roadmap for when and how to perform studies, helpful tools in designing rugged scientific studies, and guidance on how to record and communicate results.
authors.affiliation: Pfizer Global Research and Development, Analytical Research and Development, Eastern Point Road, Groton, CT 06340, USA. karen.m.alsante@pfizer.com
authors.forename: Karen M
authors.initials: KM
authors.lastname: Alsante
authors.forename: Akemi
authors.initials: A
authors.lastname: Ando
authors.forename: Roland
authors.initials: R
authors.lastname: Brown
authors.forename: Janice
authors.initials: J
authors.lastname: Ensing
authors.forename: Todd D
authors.initials: TD
authors.lastname: Hatajik
authors.forename: Wei
authors.initials: W
authors.lastname: Kong
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Tsuda
mesh_terms: D000465:Algorithms; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D004355:Drug Stability; D005544:Forecasting; D004364:Pharmaceutical Preparations / Q000032:analysis
chemical_list: D004364:Pharmaceutical Preparations