CRED Understanding Clinical Development 2024

11/10/2024

Physiologically Based Pharmacokinetic Modeling

VOLUME OF DISTRIBUTION

LYMPH NODE

BIOAVAILABILITY

CLEARANCE

Metabolism enzymes

INHIBITORY POTENTIAL

INDUCTION POTENTIAL

The Organisation for Professionals in Regulatory Affairs PREDICT DDI MAGNITUDE EVALUATE RISK OF TOXICITY & LOSS OF EFFICACY

Anatomical barriers

Lymph flow

Blood flow

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Pharmacokinetics in Phase IV

⚫ Life cycle management opportunities ⚫ Additional disease indications ⚫ Combination therapies ⚫ Pediatrics ⚫ Different formulations ⚫ Change in manufacturing processes

⚫ In scenarios where formulations or manufacturing processes change it may be necessary to re-assess bioavailability or bioequivalence i.e. demonstrate that two formulations have the same exposure within stringent limits

The Organisation for Professionals in Regulatory Affairs

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