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.
Peter Pan: The Original Tale of Neverland
Sale Price: $13.00
Not Fade Away: The On-Line World Remembers Jerry Garcia
Suggestions of Abuse: True & False Memories of Childhood Sexual Trauma
Language Imperative: How Learning Languages Can Enrich Your Life & Expand Your Mind
U.F.O.s: The Sighting of Alien People & Spacecraft From the Earliest Centuries to the Present Day
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.