Titlebook: Risk Assessment of Prenatally-Induced Adverse Health Effects; Diether Neubert,Robert J. Kavlock (Director),Jane Conference proceedings 19

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法律的瑕疵

978-3-642-77755-4Springer-Verlag Berlin Heidelberg 1992

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Risk Assessment for Pharmaceutical Productsin 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.

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Assessment of Reproductive Toxicology of Drugs at the Food and Drug Administration after mating in segment I, appropriate dose, recognizing alterations in exposure associated with pregnancy, utility of behavioural studies, and considerations for dosing across segments will be discussed in this presentation.

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