Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (Record no. 15799)
[ view plain ]
| 000 -LEADER | |
|---|---|
| fixed length control field | 01440nam a2200169Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b2008 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783527318773 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.7 |
| Item number | TOB |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Tobin, John J. |
| 9 (RLIN) | 19337 |
| 245 ## - TITLE STATEMENT | |
| Title | Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | New York |
| Name of publisher, distributor, etc | Wiley-VCH |
| Date of publication, distribution, etc | 2008 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 283p |
| 500 ## - GENERAL NOTE | |
| General note | "This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing.-"Microbiology Today, May 2009.Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs. |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Walsh, Gary |
| 9 (RLIN) | 16733 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Item type | Book |
| Call number prefix | 615.7 |
| Call number suffix | TOB |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
| Origin of item (home branch) (free text) | Pharmacy Reference |
| Genre | P0006149 |
| Section | 615.7 |
| Recipient parent organisation code | P0006149 |
No items available.