CRED Understanding Clinical Development 2024

11/10/2024

Bioanalytical method

Robust quantification method are essential Full validation includes: precision, accuracy, recovery, selectivity, sensitivity, reproducibility, long term stability testing Regulatory guidance documents Regulatory bodies will perform a thorough review of the bioanalytical method validation at final submission

The Organisation for Professionals in Regulatory Affairs

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Clinical Application of Pharmacokinetics and Pharmacodynamics

Clinical Phase

Pharmacodynamics Pharmacokinetics

Phase 1 Safety

Yes

Yes

Tolerance

Yes

Yes

Phase II

Proof of concept

Yes

Yes

Dose finding

Yes

Yes

Phase III Pivotal trials

Efficacy/safety

Population PK

Phase IV Generic drugs

Possible

Yes

Biosimilars

Yes

Yes

Line extensions

Possible

Yes

The Organisation for Professionals in Regulatory Affairs

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