Our consultant pharmacokineticists provide the following services:
- Strategic support for regulatory approaches to clinical programs.
- Design of clinical pharmacology studies including first in human, drug interaction (DDI), bioavailability and special populations.
- Pharmacokinetic and statistical analysis of drug concentrations in plasma, serum, whole blood, urine and other matrices using the industry standard software Phoenix WinNonLin™.
- Population pharmacokinetics, statistics, kinetics and data analysis, and non-linear mixed effects modeling with Phoenix NLME™.
- Support of clinical programs through in vitro characterization and animal studies, gap analysis for regulatory requirements, in vitro drug-drug interaction, cardiac effect, genotoxicity/carcinogenicity, toxicology in multiple species, toxicokinetic, statistical modeling of safety events to support NOAEL.
- Selection of biomarkers, support of assay development for PK and biomarkers, review of bioanalytical validation plans and reports; help in selection of bioanalytical methods, laboratories and vendors.