Risk Assessment for Pharmaceutical Products
As described in previous talks, pharmaceutical products are tested in a lengthy and highly redundant series of tests to identify whether they produce reproductive toxicity in laboratory animals. Considerable progress has been made in improving the design of these studies, and draft guidelines have been promulgated which reduce the redundancy and increase the flexibility of reproductive toxicity tests for drug safety evaluation (Bass et al. 1991; Lumley and Walker, 1991). With improvement in the design of animal studies, it is now possible to turn our attention to the risk assessment process for Pharmaceuticals, the process in which results from animal studies are used to predict whether adverse effects will occur in humans. The perspective I will take is that of a laboratory investigator who condenses the results from animal studies into the narrowly defined categories for use of a drug in pregnancy. This is only the first step in the risk assessment process, and subsequently clinical, legal and regulatory perspectives must be obtained on the potential uses and abuses of the drug during human pregnancy before the final label is produced.
KeywordsDevelopmental Toxicity Human Pregnancy Pregnancy Category Trimester Exposure Maternal Toxicity
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