Special Populations

One of the goals of drug development is to provide sufficient data to permit the safe and effective use of the drug.

Therefore, the patient population that participates in clinical trials should be representative of the patient population that will receive the drug when it is marketed. To a varying extent, however, women, children, and patients over 65 years of age have been underrepresented in clinical trials of new drugs. The reasons for exclusion vary, but the consequence is that prescribing information for these patient populations is often deficient.

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