Microsampling in pediatric studies: pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies.

Managing blood volumes in pediatric studies is challenging and should be minimized where possible. A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was validated and implemented across two phase III global pediatric trials. Two 10-μl aliquots of blood were collected at each time point using the Mitra device.

Quantification of abemaciclib and metabolites: evolution of bioanalytical methods supporting a novel oncolytic agent.

Bioanalytical methods undergo many revisions and modifications throughout drug development to meet the objectives of the study and development program. 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 and information about the activity and abundance of human metabolites became available.

A decade of incurred sample reanalysis: failures, investigations and impact.

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.

Incorporating dried blood spot LC-MS/MS analysis for clinical development of a novel oncolytic agent.

Aim: Design and execution of a dried blood spot (DBS-LC-MS/MS) assay for pharmacokinetic analyses in oncology patients.

Results & Discussion: The methodology was validated to collect and store DBS samples from multiple clinical sites, and analyze blood with diverse hematocrit ranges (25-55) to match the potential patient population. Bridging data comparing DBS and plasma showed high degree of concordance with DBS:plasma ratios of 0.

High sensitive assay employing column switching chromatography to enable simultaneous quantification of an amide prodrug of gemcitabine (LY2334737), gemcitabine, and its metabolite dFdU in human plasma by LC-MS/MS.

In this study we report a high sensitive method for the simultaneous analysis of LY2334737 (2'-deoxy-2',2'-difluoro-N-(1-oxo-2-propylpentyl)-cytidine), an amide prodrug of gemcitabine (2', 2'-difluoro-deoxycytidine), along with its active drug gemcitabine and its major metabolite dFdU (2',2'-difluoro-deoxyuridine) by LC-MS/MS. Quantification of all three analytes within a single analysis was challenging because the physio-chemical properties of LY2334737 were significantly different from gemcitabine and dFdU and was accomplished by incorporating column-switching. The assay was fully validated to quantify LY2334737 from 0.

The association of race, socioeconomic status, and health insurance status with the prevalence of overweight among children and adolescents.

Objectives: We examined the effect of race, socioeconomic status, and health insurance status on the prevalence of overweight among children and adolescents.

Methods: We studied an observational cohort from the 1996 Medical Expenditure Panel Survey Household Component.

Results: In the younger group, both Black and Latino children had a greater likelihood of being overweight compared with White children.