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July 27, 1963

Expert Consultants Required For Safety in Drug Evaluation

JAMA. 1963;185(4):35. doi:10.1001/jama.1963.03060040013010

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Expert consultative panels would be "most helpful" in achieving safety during the clinical pharmacological evaluation of new drugs, Dr. Dale G. Friend of Boston told the AMA Annual Meeting in Altantic City.

"In view of the fact that thalidomine slipped through the best screening techniques we knew to date, we have no positive assurance that history won't repeat itself," Friend said. "And since the search for therapeutic agents can't be suspended, we must explore all of the safety factors relating to the prevention and control of adverse reactions."

Friend hailed the investigator as the most important safety factor to be considered when a new agent is evaluated in man for the first time. Human drug evaluation requires "competent individuals with motivation, training and skill working in surroundings that afford the best possible facilities." He recommends that an "adequately trained" clinical pharmacologist have special training in biochemistry, pharmacology, or physiology with

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