Module 9 2024

03/09/2024

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

The Organisation for Professionals in Regulatory Affairs

* CHMP/EWP/89249/2004

17

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

The Organisation for Professionals in Regulatory Affairs

18

9