CRED Understanding Clinical Development 2024

08/10/2024

Legal basis difficulties (I)

New MAA – Article 8.3 – Full application

PK

Dose-response studies

•

PK modeling

•

Efficacy

• Randomized, double-blind, placebo/active controlled study

• Clinically relevant and statistically significant benefit

Safety

Lack of long-term safety data

•

The Organisation for Professionals in Regulatory Affairs

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Legal basis difficulties (II)

Generic – Article 10.1

• Bio-equivalence study/BCS biowaiver –

Bioequivalence study: Randomized, two period, two-sequence, cross-over study in healthy volunteers

Hybrid – Article 10.3

• Comparative quality, in-vitro, in-vivo, PK, PD, efficacy and safety (Therapeutic equivalence study) – Therapeutic equivalence study: Randomized, double-blind, placebo and active controlled study

The Organisation for Professionals in Regulatory Affairs

6