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The Pharmaceutical regulatory process .-2nd ed .-9781420070422 (Record no. 40180)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01621nam a2200133Ia 4500 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781420070422 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 344.7304 Ber/Mar |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Berry, Ira R (ed) & Martin, Robert P (ed) |
| 245 ## - TITLE STATEMENT | |
| Title | The Pharmaceutical regulatory process .-2nd ed .-9781420070422 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Informa Healthcare, New York |
| Date of publication, distribution, etc. | 2008 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | x,469 |
| 505 ## - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug approval- process - before and after 1962 / Michael P. Peskoe -- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA’s antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England.~~2nd ed~~text~~ill.~New York~Informa Healthcare~Hb~9781420070422~Drugs and the pharmaceutical sciences a series of textbooks and monographs~~The Pharmaceutical regulatory process~Rs. 6995~x,469~2008~~~~~~~~~ |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Book |
| Withdrawn status | Lost status | Damaged status | Not for loan | Home library | Current library | Date acquired | Cost, normal purchase price | Total checkouts | Full call number | Barcode | Date last seen | Cost, replacement price | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SNDT Juhu | SNDT Juhu | 17/11/2012 | 6995.00 | 344.7304 Ber/Mar | 065653 | 07/07/2025 | 6995.00 | 19/03/2024 | Book |