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Clinical challenge is to provide effective treatment for the mother while avoiding harm
to the fetus or nursing infant
A. PHYSIOLOGIC CHANGES DURING PREGNANCY & THEIR IMPACT ON DRUG DISPOSITION & DOSING
- changes in the kidney, liver and GI tract are of particular concern
B. IDENTIFICATION OF TERATOGENS
- human teratogens are extremely difficult to identify:
• incidence of congenital anomalies is generally low
• animal tests may not be applicable
• prolonged exposure may be required
• teratogenic effects may be delayed
• behavioral effects are difficult to document
• controlled experiments can’t be done in humans
Criteria:
- drug must cause a characteristic set of malformations
- it must act only during a specific window of vulnerability
- incidence of malformations should increase with increasing dosage
and duration of exposure