What happens after the "delight of discovery" of a new drug?
Is the preclinical safety evaluation adequate?
When is a clinical trial indicated?
What safety factors must be considered?
How are long-term clinical trials conducted?
ANY DRUG, NEW OR OLD, miraculous or mediocre, will affect or appear to affect some patients adversely. Even bed rest has been called the most dangerous of therapeutic procedures. The safety of a drug can be assessed sensibly only in terms of what it is intended to do.
Both modern therapeutics and the safety assessment of these remarkable new drugs have advanced tremendously in our generation of research and practice. Drug research is an exciting, exacting and demanding field wherein one constantly seeks to reach beyond the limits of present knowledge for achievement, knowing full well that an unknown, an unanticipated, or a previously unexamined aspect of a new and
Beyer KH. Introductory Remarks. JAMA. 1964;187(5):340. doi:10.1001/jama.1964.03060180026006
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