Drug data to support decision-making
PAREXEL provides expert pharmacokinetic (PK) services to monitor and analyze how the body absorbs – and how long it retains – drugs after they are administered. This data is critical in enabling clients to make decisions on whether or not to continue the study. We work with clients to proactively develop a PK strategy as an integral part of the drug development plan and design clinical studies in order to address specific PK objectives.
PAREXEL employs an experienced and highly knowledgeable pharmacokineticist, and all PK variables are derived utilizing the latest version of WinNonlin, the industry standard in PK and pharmacodynamic (PD) modeling and noncompartmental analysis. WinNonlin is fully validated and also facilitates our ability to perform in vivo/in vitro correlations, as well as multiple-dose modeling from single-dose data.
Among the PK studies we’ve done successfully are:
- Toxicokinetics
- ADME mass balance
- Bioavailability/bioequivalence
- Single ascending dose
- Multiple ascending dose
- Drug-drug interaction
- Food interaction
- Special populations: hepatic/renal impairment; gender effect; age effect
