Case Studies

The following case studies are available for download without charge or obligation:

• Application Note #2008-BM-001 Genotyping
  This Application Note describes how SNP genotyping of CP450 drug metabolism enzymes and ApoE data can be used for patient stratification in clinical trials.

• Application Note #2008-DMPK-001 QWBA and Metabolite Profiling
  This Application Note demonstrates how the combination approach of QWBA, MARG and tissue metabolite profiling using radio-HPLC and/or LC-MS/MS can reveal specific localization of the dosed compound and metabolites at both the whole-body and cellular level.

• Application Note #2008-DMPK-002 Clinical Plasma Protein Binding
  This Application Note shows the type of ex vivo protein binding data that can be generated, and the value of knowing the extent of plasma protein binding in guiding the design and execution of the clinical development plan for a drug.

• Application Note #2008-DMPK-003 Oral Formulation Optimization
  This Application Note describes a tiered approach that includes in vitro solubility assays with minimum compound requirements to identify dosing vehicles that might be most useful for oral delivery for preclinical pharmacokinetic studies. We also provide examples of the application of this tiered approach for two poorly water soluble compounds already available as marketed drugs.

• Application Note #2009-LC-MSMS-001 Incurred Sample Reanalysis
  This Application Note examines Incurred Sample Reanalysis (ISR) as a metric of improved quality control and presents statistics from the first 14 months of a company-wide SOP using ISR at QPS. The publication also takes a look at two case histories and illustrates the inferences that can be made from a careful reanalysis of study samples.