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Title:
New drug approval process
Author:
Guarino, Richard A., 1935-
ISBN:
9781420088502
Edition:
5th ed.
Publication Information:
New York : Informa Healthcare, c2009.
Physical Description:
xviii, 529 p. : ill.
Series:
Drugs and the pharmaceutical sciences ; v. 190
Series Title:
Drugs and the pharmaceutical sciences ; v. 190
Contents:
pt. 1. Administrative guidelines for new product development -- pt. 2. Global regulatory submission of drugs, biologics and devices for new product approval -- pt. 3. Developing clinical research trials -- pt. 4. Global regulations for good clinical practices (GCP) -- pt. 5. Specific areas of new product submissions.
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