CRED Understanding Clinical Development 2024

11/10/2024

Phase III Studies

Large patient studies primarily to assess safety and efficacy

Pharmacokinetics

Compliance assessment Population pharmacokinetics (PopPK) to identify subgroups or characteristics influencing PK and PD Therapeutic drug monitoring Fewer observations in more patients (Sparse PK data modeling) Pharmacodynamics Usually ‘macro - scale’ Based on therapeutic outcome

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Population Pharmacokinetic Modelling

COMPARTIMENTAL MODEL

Clearance

V ss

Rate of absorption

IDENTIFICATION and MATHEMATICAL DESCRIPTION OF PREDICTORS

CHARACTERISATION of KEY PK VARIABLES

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