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Panel 2: Phase II investigations
Author(s) -
Hollister Leo E.,
Martz Bill L.,
Carr Edward A.,
Cohn Howard D.,
Crout J. Richard,
Levine Jerome
Publication year - 1975
Publication title -
clinical pharmacology and therapeutics
Language(s) - Uncategorized
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1975185part2647
Subject(s) - drug development , phase (matter) , risk analysis (engineering) , drug , process (computing) , point (geometry) , medicine , computer science , intensive care medicine , business , pharmacology , mathematics , chemistry , geometry , organic chemistry , operating system
At the end of Phase II, a decision must be made as to whether or not the drug should be developed as a therapeutic agent. Such a decision may be based on many criteria in addition to the scientific data derived from the Phase II study. At this point, expert judgment is needed. One should like to assume that if the decision is made to proceed with the increasingly expensive and laborious process of further development, the drug will, barring some completely unforeseen misadventure, ultimately find its way into clinical therapeutics. Phase II studies, therefore, are the most crucial stage in the course of drug development. Planning of these studies requires great care and investigators of the highest caliber should be used for their conduct. The escalating costs of new drug development are resulting in an undesirable imbalance of efforts in the direction of studies characterized more by easily defined end points than by therapeutic needs. Industry, academia, and the FDA must all be concerned with facilitationg studies in areas of most-needed therapeutic advances.