Abstract：
:Guidelines have been developed by the Bureau of Drugs, FDA, for antinflammatory drug development. They address the problem of efficacy and safety testing but leave the definition of qualified investigators and appropriate subjects unstated. The natural history of rheumatoid arthritis, the most-studied chronic inflammatory disorder, is not sufficiently appreciated, and "controlled" studies are too narrowly structured to give adequate information. By contrast, other countries speed the review process by emphasizing early toxicity studies and letting the market place determine relative efficacy while long-range safety data are carefully monitored.
journal_name
J Clin Pharmacoljournal_title
Journal of clinical pharmacologyauthors
Ehrlich GEdoi
10.1002/j.1552-4604.1977.tb01544.xsubject
Has Abstractpub_date
1977-11-01 00:00:00pages
697-703issue
11-12eissn
0091-2700issn
1552-4604journal_volume
17pub_type
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