ABT Reproductive and Developmental Toxicology 2

Question 1

ICH S5(R3) guidelines govern which aspect of pharmaceutical development?

Accepted Answer

Detection of reproductive and developmental toxicity for human pharmaceuticals

Answer

Genotoxicity testing

Answer

Carcinogenicity studies

Answer

Acute toxicity study design

Question 2

A 'developmental NOAEL' is used in risk assessment to protect against which type of toxic effect?

Accepted Answer

Adverse effects on the developing organism (structural, functional, or growth-related)

Answer

Maternal mortality from high-dose exposure

Answer

Carcinogenicity in offspring

Answer

Mutagenicity in germline cells

Question 3

Alcohol is a well-established human teratogen. The most severe outcome of prenatal alcohol exposure is:

Accepted Answer

Fetal alcohol syndrome (FAS) — growth restriction, CNS abnormalities, and facial dysmorphology

Answer

Fetal alcohol spectrum disorder (FASD) — neurobehavioral effects only

Answer

Neonatal abstinence syndrome

Answer

Neural tube defects only

Question 4

Which test in the developmental toxicity battery specifically evaluates learning and memory deficits caused by in utero chemical exposure?

Accepted Answer

Developmental neurotoxicity (DNT) study

Answer

Teratology study (Segment II)

Answer

Two-generation reproductive study

Answer

Epigenetic methylation assay

Question 5

Which male reproductive toxicant causes depletion of spermatogonia by alkylating DNA in the seminiferous epithelium?

Accepted Answer

Dibromochloropropane (DBCP)

Answer

Bisphenol A (BPA)

Answer

Phthalates (DEHP)

Answer

Vinclozolin

Question 6

Valproic acid is a potent human teratogen that primarily causes which neural tube defect when taken in the first trimester?

Accepted Answer

Spina bifida (myelomeningocele)

Answer

Anencephaly

Answer

Holoprosencephaly

Answer

Dandy-Walker malformation