Module 5 Presentations

16/07/2024

Female Reproductive toxicology – ICH M3 (R2)

WOCBP without Highly effective contraception or unknown pregnancy status

For any clinical investigation…… Complete all female reproduction studies Standard genetic toxicology tests

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

29

Male Reproductive Toxicology – ICH M3 (R2)

• Men can be included in Phase I and II trials • Before the conduct of the rodent male fertility study • Evaluation of the male reproductive organs is performed in the repeated-dose toxicity studies ≥2 weeks • High quality histopathology material • Assess spermatogenesis process • Mature animals • Before initiation of large scale or long duration trials • Usually Phase 3 trials (not always) • A male fertility study (Ref. 3) should be completed

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

30

15