Non-Clinical and Clinical Pharmacokinetics

From the early days in 1997 onwards, our early development team have become a preferred provider for many innovative pharmaceutical companies that outsource their pharmacokinetic analysis, including 3 out of the top 10 biggest pharmaceutical companies.

Non-clinical Pharmacokinetics/Toxicokinetics (PK/TK)

Venn’s non-clinical consultants have performed noncompartmental PK/TK analyses (NCA) for all types of non-clinical development studies (GLP & non-GLP), such as toxicology, ADME, bioequivalence and bioavailability studies. Each PK/TK analysis is performed in accordance with the principles of GLP and all our relevant Standard Operating Procedures (SOPs). An in-house validated WinNonlin routine is used for noncompartmental analysis of non-clinical PK/TK (e.g. Cmax, AUC, half-life).

Clinical Pharmacokinetics

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 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.

Venn also performs more advanced PK/PD analysis, modelling, and simulation.