Buy a book... 
| New Drug Approval Process. The Global Challenge | Buy a book...
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| Author(s): | R. A. Guarino (Ed.) |
| Publisher: | Marcel Dekker |
| ISBN: | 0 8247 0308 1 |
| Format: | hardback |
| 471pp | |
| Price: | $185.00 |
| Review Date: | 23 May 2000 |
| Review: | This book provides the latest information and methodologies on the mechanics of preparing INDs and NDAs. New ways to expedite the process are detailed. The book is divided into five parts. The first part, Regulatory Aspects of New Drug Development, considers the essential aspects of the clinical and nonclinical development of products along with the regulatory requirements necessary for regulatory agents' approval. The next two parts, Clinical research and Development and Good Clinical Practice, detail the necessary steps in the clinical development process. Part IV, The Orphan Drug and the Rx to OTC Switch, are written by specialists who have had experience of obtaining FDA approval in these areas. The last topic, Effective Methodology in Expediting NDA approval, gives new information that is not included in earlier editions. The authors give combined information with insight on the mechanics of getting new products approved globally. |