4.2.3.5 — Reproductive and Developmental Toxicity
Reproductive and developmental toxicity studies: fertility, EFD, pre/postnatal, juvenile
Requirements by Phase
Reproductive and developmental toxicity studies: fertility, EFD, pre/postnatal, juvenile
Requirements by Phase
IND Phase 1: optional IND Phase 2: required IND Phase 3: required NDA: required
Source: ICH S5(R3)
Cross-References: Study duration relates to Repeat-Dose Toxicity program length. Summarized in the Toxicology Written Summary.
References
Sections
Fertility and early embryonic development study (Segment I) evaluating effects on male/female fertility
Embryo-fetal development study (Segment II) in 2 species (rodent + rabbit) evaluating teratogenic potential
Pre- and postnatal development study (Segment III) evaluating effects on offspring development
Juvenile animal toxicity studies for drugs intended for pediatric use
Related Articles
Related Sections
Up toModule 4: Nonclinical Study ReportsPharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions
Pharmacokinetics studies: analytical methods, ADME, PK drug interactions
Acute toxicity studies in 2 species (rodent and non-rodent) to determine lethal dose and target organ toxicity
Repeat-dose toxicity studies with duration matching or exceeding planned clinical exposure. ICH M3(R2) Table 1 defines minimum durations.
Genotoxicity studies: in vitro (Ames, chromosomal aberration) and in vivo (micronucleus)
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