ABSTRACT
This chapter explores the last proposition both in terms of the inherent limitations of the methodology and strategies for improving the detectability of adverse drug effects. A principle of teratogenesis is that the ability of a drug to cause harm depends on the timing of use of that drug in relation to the susceptibility of the developing embryo. It aims to present principles for detection of drug effects on human reproduction and to consider methodologic approaches when applying these principles. The discovery of drug-induced interference of normal reproductive events is an epidemiologic challenge. If the effect of a drug that commonly causes an event that is otherwise rare is observable during the pregnancy or within a year of the birth, formal epidemiologic studies to confirm the observations can be conducted to identify the pharmacologic cause. Studies of the etiology of birth defects in relation to maternal drug use, in general, require formal epidemiologic investigations.
