Join our mailing list!
(Your shopping cart is empty)
Diane Publishing Books
New Drug Approval: FDA’s Consideration of Evidence from Certain Clinical Trials
Before approving a new drug, the FDA assesses a drug's effectiveness. To do so, it examines info. contained in a new drug application (NDA), including data from clinical trials in humans. Several types of trials may be used to gather this evidence. Non-inferiority trials aim to demonstrate that the difference between the effectiveness of a new drug and an active control is small enough to show that the new drug is also effective. FDA has issued guidance on these trials. This report: (1) identifies NDAs for new molecular entities -- potentially innovative new drugs not FDA-approved in any form -- that included evidence from non-inferiority trials; (2) examines the characteristics of these trials; and (3) describes FDA's guidance on these trials. Illustrations.
Guide to Metal Toys
Southern World: Trade & Travel Routes
Calendars & Constellations of the Ancient World
People’s Charter?: Forty Years of the National Parks & Access to the Countryside Act 1949
American Short Story, 1945-1980: A Critical History
Share your knowledge of this product with other customers...
Be the first to write a review
Diane Publishing Co
PO Box 617
Darby, PA 19023-0617
Become an Affiliate
Send Us Feedback
Copyright ï¿½ 2004 Diane Publishing Company. All Rights Reserved.