FDA regulatory affairs a guide for prescription drugs, medical devices, and biologics için kapak resmi
Başlık:
FDA regulatory affairs a guide for prescription drugs, medical devices, and biologics
Yazar:
Pisano, Douglas J.
ISBN:
9781420073553
Basım Bilgisi:
2nd ed.
Yayın Bilgileri:
New York : Informa Healthcare USA, c2008.
Fiziksel Tanımlama:
viii, 448 p. : ill.
İçerik:
1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- 2. What is an IND / Michael R. Hamrell -- 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- 4. Meeting with the FDA / Alberto Grignolo -- 5. FDA medical device regulation / Barry Sall -- 6. The development of orphan drugs / Tan T. Nguyen -- 7. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- 8. Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- 10. Electronic submissions : a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vah ̌Ghahraman -- 11. The practice of regulatory affairs / David S. Mantus -- 12. A primer of drug/device law : what's the law and how do I find it? / Josephine C. Babiarz -- 13. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- 14. Biologics / Timothy A. Keutzer.
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