Clinical & Preclinical Pharmacokinetics
Pharmacokinetic (PK) and toxicokinetic (TK) services to support small and large molecule therapeutic drugs in development from discovery through Phase I-III clinical trials.
Intertek’s offers expert bioanalytical TK/PK support services through dedicated senior dispositional scientists experienced with both large and small molecule drug candidates targeted at a wide range of different therapeutic areas, often with unique drug-specific PK considerations.
- Bioavailability and bioequivalence for generics, biosimilars and drug delivery clients
- Compartmental and non-compartmental pharmacokinetics
- Preclinical toxicokinetic analysis
- Phase I and II/III clinical pharmacokinetic analysis
- Integration of PK and immunogenicity (anti-drug antibody or ADA) data
- Dose escalation and dose proportionality assessments
- Drug-drug interaction kinetics
- Biomarker assessment and PK/PD modeling
- Repeat dose and assessment of steady state kinetics and linearity
- Guidance on preclinical to clinical (allometric) scaling
- Special populations
- PK/TK study design, protocol writing and drug disposition
Intertek functionally links GLP-compliant TK/PK analyses with our world class bioanalytical capabilities in order to provide flexible scheduling and rapid turn-around times for dispositional evaluations. Intertek has a dedicated QAU for clinical and preclinical pharmacokinetics and offers experts with combined pharmacokinetic experience of 40+ years for developing both small molecule and macromolecule therapeutics.
Related PK/TK Services
Request more information to see how Intertek can help your organization with Clinical & Preclinical Pharmacokinetics.