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The position of the pharmaceutical industry in the development of drugs for pediatric use.

There is broad agreement that drugs to be used by children should be evaluated in children. Dosage and side effect information, in particular, cannot be reliably extrapolated from data derived from studies in adults. Few problems are encountered in obtaining adequate studies in children of drugs such as antibiotics which have a high potential for use in the pediatric age group. A large number of drugs will have limited use in children. They should be studied in children but the relative scarcity of qualified investigators, the limited patient population available for study, and ethical considerations dictate that the studies will be completed long after studies are completed in adults. These drugs should be allowed on the market before pediatric studies are completed, but there should be a commitment by the sponsor to complete the studies so that all drugs used by children will have adequate directions for use.