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Development and Approval of Combination Products: A Regulatory Perspective
Evan B. Siegel
€ 119.14
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Description for Development and Approval of Combination Products: A Regulatory Perspective
Hardcover. A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Editor(s): Siegel, Evan B. Num Pages: 216 pages, Illustrations. BIC Classification: MMG; TCB; TDCW. Category: (P) Professional & Vocational. Dimension: 239 x 161 x 19. Weight in Grams: 514.
A step-by-step, integrated approach for successful, FDA-approved combination drug products
Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.
The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, ... Read more
A step-by-step, integrated approach for successful, FDA-approved combination drug products
Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.
The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, ... Read more
Product Details
Format
Hardback
Publication date
2008
Publisher
John Wiley & Sons Inc United Kingdom
Number of pages
216
Condition
New
Number of Pages
240
Place of Publication
, United States
ISBN
9780470050941
SKU
V9780470050941
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
About Evan B. Siegel
Evan B. Siegel, PhD, is President and CEO of Ground Zero Pharmaceuticals, Inc., and an Adjunct Professor at the University of Queensland in Australia. Dr. Siegel has held positions as a Toxicology Reviewer at the U.S. Food and Drug Administration and Supervising Toxicologist in the California Department of Health Services. He has also served in regulatory affairs and executive positions ... Read more
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