Phase 1 is a drug development stage where you start the clinical evaluation of the drug. You plan Phase 1 study using the information you have at hand, based on the preclinical toxicokinetic studies. Preclinical data are often used for the development of translational models that could support the first-in-human dose selection. Frequent samples collected during Phase 1 studies help to characterize pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles. Pharmacometric analysis of Phase 1 data can help to support following objectives of Phase 1 studies:
Assess Safety & Tolerability
- Exposure-response analysis can help to assess safety profile and determine the maximum tolerated dose (whenever possible)
- Whole-body physiologically based PK (PBPK) model can be used to study the drug disposition in the body including absorption, distribution, metabolism, and excretion
- Population PK model can be used to characterize the source of variability in the drug pharmacokinetic parameters
- Such models can help to evaluate drug-drug interaction, support dose selection in special population (eg, pediatric or renal impairment subjects), study dose linearity, and characterize target tissue concentration-time profile
- PK/PD model can help to characterize the relationship between drug concentration and biomarker or disease endpoint.
- Such model can support early proof of target engagement and evidence based dose selection for future studies.
Yogesh Patel, Associate Director of Quantitative Clinical Pharmacology for Cognigen presented at the 2021 MIDD+ conference. Click here to stream his talk about Application of Pharmacometrics in Phase I studies – the bridge between preclinical and clinical development.
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