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| Available: 0 |
| List Price:$137.25 |
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| Edition: | 1st |
| Publisher: | Wiley-Blackwell |
| ISBN: | 3-527-31877-1 (3527318771) |
| ISBN-13: | 978-3-527-31877-3 (9783527318773) |
| New Edition: | 3-527-33326-6 |
| Binding: | Hardcover |
| Copyright: | 2008 |
| Publish Date: | 08/08 |
| Weight: | 1.50 Lbs. |
| Pages: | 297 |
| Carton Quantity: | 20 |
| Subject Class: | PHM (Pharmacy and Pharmaceutical Industry) |
| Remarks: | A New Edition of this Title is Available |
| Return Policy: | Returns accepted up to 12 months provided no other recalls or return restrictions apply. |
| Table Of Contents: |
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| Contributing Authors: |
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| ProQuest Ebook Central: |
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| Discipline: | Pharmacology | | Subject Definition: | Pharmaceutical Prep-Stand; Legilation, Drug; Device Approval | | NLM Class: | QV 771 | | LC Class: | K3636 | | Abstract: | Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs. |
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