Module 9 2021

19/03/2021

Clinical Pharmacology

Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (CHMP; 2007*) ● Highlights specific issues related to the PK of protein products – Long elimination half-life, prolonged PD effects, plasma PK not indicative of PD response ● Provides an awareness of the differences in PK characteristics between

proteins and small molecules that can impact the CDP ● Offers recommendations on the PK CDP for proteins

* CHMP/EWP/89249/2004

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The Organisation for Professionals in Regulatory Affairs

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PK/PD Modelling in Clinical Studies

Population PK/PD analysis continues throughout the CDP to reduce uncertainty ● Monitor effects of covariates – Body weight, body surface area, gender, drug-drug interactions ● Intra and inter-individual variability ● Time-dependency ● Impact of antibody development on the PK/PD profile Population PK/PD modelling can be beneficial for lifecycle management changes ● Comparability to support manufacturing changes ● Development of new formulations, routes of administration

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The Organisation for Professionals in Regulatory Affairs

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