Module 3 2019

How are specifications set

Considering the safety of volunteers and patients

Tests and Acceptance Criteria set considering: ● Pre-clinical safety (Tox) data [Impurities] ● Bioavailability data [Pharmacokinetics, Dissolution, Particle Size] ● Stability data ● Other information (e.g. clinical info, process understanding, design space, statistics) Considering the principles in guidance: ● ICH (Q6A [Q6B], Q3A, Q3B, Q3C, Q3D) [Q5A, Q5B, Q5C, Q5D, Q5E] ● Internal guidances ● Guidance for Industry (e.g. Biowaiver guidance)

The Organisation for Professionals in Regulatory Affairs