Toxicokinetics
Intertek offers rapid, expert GLP toxicokinetic analysis, interpretation and TK reporting of bioanalytical data generated from preclinical toxicology and drug metabolism studies.
Intertek offers extensive bioanalytical and toxicokinetic (TK) expertise through dedicated senior dispositional scientists experienced with both large and small molecule drug candidates targeted at a wide range of different therapeutic areas. Intertek provides seamless integration of GLP-compliant TK analyses with world class bioanalytical capabilities in order to accelerate and shorten drug development time-lines from discovery through preclinical development.
- Compartmental and non-compartmental toxicokinetic analysis
- Integration of TK and immunogenicity (anti-drug antibody or ADA) data
- Dose escalation and dose proportionality assessments
- Drug-drug interaction kinetics
- Repeat dose and assessment of steady state kinetics and linearity
- Guidance on preclinical to clinical (allometric) scaling
- TK study design, protocol writing and drug disposition
GLP-validated state-of-the-art software, Phoenix™ WinNonlin® v. 6.1, with modular architecture adopted for use by the FDA with rapid and secure data transfer from Intertek's bioanalytical laboratories to the TK group using Watson LIMS, v. 7.4.1. TK reports are designed and customized to meet client-specific formats, then reviewed promptly by Intertek’s dedicated QAU. All data archived under secure conditions.
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