Module 18 2021

08/02/2021

Guidelines – Drug formulation

G UIDANCE ON NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTHORIZATION FOR PHARMACEUTICALS M3(R2)

• Provides guidance on toxicology studies required to support clinical development/product registration

The Organisation for Professionals in Regulatory Affairs

5

Guidelines – Drug formulation

Guidance for Industry and FDA Staff

Early Development Considerations for Innovative Combination Products

The Organisation for Professionals in Regulatory Affairs

6

3