From the early days in 1997 onwards, Kinesis Pharma has become a preferred provider for many innovative pharmaceutical companies that outsource their pharmacokinetic analysis, including 3 out of the top 10 biggest pharmaceutical companies.
A team of well trained PK data analysts and report writers, supervised by experienced consultants with a solid background in clinical pharmacokinetics, is committed to delivering optimal quality within agreed timeframes for each (interim) PK analysis. Over the last decade large numbers of noncompartmental PK analyses (NCA) have been performed for all type of Phase 1 studies including first-in-man, ADME studies, drug drug interaction studies, bioequivalence and bioavailability studies, studies in special populations and other PK studies during phase 2/3.
In-house validated WinNonlin and SAS routines are among the programs used for noncompartmental analysis of the pharmacokinetic parameters (e.g. Cmax, AUC, half-life) and reporting of the data in tables and graphs, including exploration of PK/PD relationships.
Each pharmacokinetic analysis is performed by competent and qualified staff, according to high quality GCP based standard operating procedures (SOPs) using validated software. Additionally, all data and calculations are checked by an independent reviewer, before the final PK report is peer reviewed internally.
Kinesis Pharma also performs more advanced PK/PD analysis, modeling and simulation.