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Biomedical subjects

C N Christensen

Publications and source records attributed to C N Christensen.

3 recordsLinked to original sources
PubMed1980

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.

Adolescent↗
PubMed1978

Federal regulation: philosophy and practice.

The philosophy of drug regulation as expressed by Congress has progressively embraced concepts of misbranding and adulteration, safety, efficacy, and, most recently, control of the investigational process. The intent of Congress has been implemented by a series of regulations intended to protect the public health and to assure that available drugs are safe and effective. This has resulted in more centralized, standardized, uniform government control, with a slowdown in the development and approval of new drugs, an increase in the cost of developing and marketing new drugs, and costly control procedures. It is time to ask whether the benefit of more centralized government control is being exceeded by its cost.

Clinical Trials as Topic↗