Spring Intro 2023

03/03/2023

The Nonclinical Overview

Pharmacodynamics - Rational for development; primary screening methods and validation; mechanism of action; receptor occupancy, secondary and/or safety pharmacology; chirality; drug interactions – less important as more clinical efficacy data generated but crucial at early clinical trial stage!!

Pharmacokinetics -

ADME; validation and sensitivity of assays; demonstration of suitability of animal models; comparative exposure .

Often see Toxicokinetics here.

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Drug:Drug Interactions VERY IMPORTANT!

Is the PK and/or PD of one drug influenced by another or something else? Generally evaluated initially in vitro and definitive studies in humans. European and USA guidelines available.

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