Module 5 Presentations

16/07/2024

REPRODUCTIVE & DEVELOPMENTAL TOXICOLOGY ICH S5 (R3) SIX PHASES OF REPRODUCTIVE PROCESS TO BE STUDIED Three routine screening protocols

• Pre-mating to conception • Conception to implantation

“Fertility & Early Embryonic Development (FEED)”

• Embryo-Fetal development - mid-pregnancy • Fetal development - late pregnancy

“Embryofetal” Development

• Birth to weaning • Weaning to sexual maturity

“Pre/post natal”

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

27

Female Reproductive toxicology – ICH M3 (R2)

Women of Childbearing Potential (WOCBP) with Highly effective contraception

Limited scale trials Generally up to 3 months, 150 subjects total Preliminary Embryofetal Development studies (2 species, 6 litters/group) Female fertility studies not required

Larger scale trials GLP Embryofetal Development studies (2 species, 16-20 litters/group) (US does not require EfD studies until Phase III) Female Fertility study – Prior to Phase 3

For Marketing Applications As above + Pre/post natal study

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

28

14