Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updates.

ABSTRACT: Pharmaceutical applicants conduct (Q)SAR assessments on identified and theoretical impurities to predict their mutagenic potential. Two complementary models-one rule-based and one statistical-based-are used, followed by expert review. (Q)SAR models are continuously updated to improve predictions, with new versions typically released on a yearly basis. Numerous releases of (Q)SAR models will occur during the typical 6-7 years of drug development until new drug registration. Therefore, it is important to understand the impact of model updates on impurity mutagenicity predictions over time. Compounds representative of pharmaceutical impurities were analyzed with three rule- and three statistical-based models covering a 4-8 year period, with the individual time frame being dependent on when th

SUBMITTER: Hasselgren C 

PROVIDER: S-EPMC7734868 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature