Clinical Pharmacology & Phase 1 Clinical Trials

Helping guide the success of your product development

In drug development, a proper clinical development strategy, implemented at an early stage of product development, helps to guide the success (and cost-effectiveness) of the product development. To understand the kinetics of a drug in terms of absorption, distribution, metabolism and elimination (ADME), pharmacokinetic (PK) studies are performed. In addition, often the pharmacodynamics (PD), ie. the biochemical and physiologic effects of the drug, are monitored. To analyse PK and/or PD data, non-compartmental analysis (NCA) and model-based analysis (modelling & simulation) are used. For more than 20 years, (interim) noncompartmental PK and PD analyses have been performed within Venn Life Sciences for many pharmaceutical companies for all types 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.

Offering a broad range of expertise in Clinical PK & Pharmacometrics

Modelling & Simulation (M&S) has been used during early Phase 1 and 2a studies at an exploratory stage to predict PK and/or PD for planned dose groups or for predictions to multiple dosing. To support label claims M&S was applied in cross-study population analyses to model the relationship between PK-PD and certain covariates (e.g. age, weight, genotype and disease state). Within Venn Life Sciences translational M&S was used to extrapolate non-clinical PK-PD data to humans and human adult data to paediatric populations. Each PK/PD 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 independently checked for quality before the report is peer reviewed internally.

Venn Life Sciences can support you in:

Clinical PK & Pharmacometrics

Translation from preclinical to clinical phase (defining a safe starting dose in human by means of modelling and simulation)
Translation from adult to paediatric population (derive dose adjustments resulting in appropriate exposure in children)
Non-compartmental PK and PD analysis and reporting
NONMEM dataset SAS programming
Population PK(/PD) modelling