There are substantial racial differences in the prevalence of overweight for children and adolescents. Health insurance status is associated with the prevalence of overweight among adolescents.

Aim: Bioanalytical methods undergo many revisions and modifications throughout drug development to meet the objectives of the study and development program. Results: Validated LC–MS/MS methodology used to quantify abemaciclib and four metabolites in human plasma is described. The method, initially validated to support the first-in-human study, was successfully modified to include additional metabolites as in vitro and in vivo information about the activity and abundance of human metabolites became available. Consistent performance of the method over time was demonstrated by an incurred sample reanalysis passing rate exceeding 95%, across clinical studies. An overview of the numerous methods involved during the development of abemaciclib, including the quantification of drugs evaluated as combination regimens and used as substrates during drug–drug interaction studies, is presented. Conclusion: Robust bioanalytical methods need to be designed with the flexibility required to support the evolving study objectives associated with registration and post-registration trials.

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Incurred sample reanalysis (ISR) is used to ensure the validity and reliability of bioanalytical data. Additionally, ISR results also help identify issues that could influence or bias the data. Overall, based on a decade of experimental data generated at Eli Lilly and Company, ISR failures are few with less than 5% of ISR samples failing to meet acceptance criteria. In a majority of situations, the cause for ISR failures has been ‘human-error.’ However, there are examples where ISR has helped identify issues related to the stability of the analyte or the ruggedness of the method. As a strategy, it is beneficial to conduct ISR following the completion of a few sample runs, so any potential issues impacting the validity and reliability of the data can be identified and rectified early.

Successful validation of a DBS method and implementation in the clinic enabled pharmacokinetic analysis during the clinical development of a novel oncolytic agent in oncology patients.