Question

Write in detail about study design and management of Reproductive Toxicity.

Answer 1

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Risk assessment process

•

Hazard identification

–

depends on data quality and

relevance of the animal model

•

Hazard characterisation

–

find sensitive period and relevant dose metric

–

biomarkers

–

mechanistic basis for interspecies extrapolation

•

Dose-response assessment

–

quantitative relationships,

not just administered dose

•

Human exposure assessment

–

subpopulations may differ

•

Risk characterisation- integration of above

Toxicity

•

Repeated

dose

toxicity

To

detect

–

target organ

toxicity

–

at a relevant exposure

(toxicokinetics)

–

histopatholological

screening

of fertility

•

(in the EU and US 14 days is sufficient)

–

local

tolerance

might

be

included