000 | nam a22 7a 4500 | ||
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999 |
_c44798 _d44798 |
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001 | 39349 | ||
003 | BD-DhAAL | ||
008 | 220814r20222008nyua b 001 0 eng d | ||
010 | _a 2008042661 | ||
016 | 7 |
_a101485457 _2DNLM |
|
020 | _a9780367202842 | ||
020 | _a9781420070422 (hardcover : alk. paper) | ||
040 |
_aBD-DhAAL _cBD-DhAAL |
||
082 | 0 | 0 |
_a344.7304233 _223 |
245 | 0 | 4 |
_aThe pharmaceutical regulatory process / _cedited by Ira R. Berry, Robert P. Martin. |
260 |
_aNew York : _bInforma Healthcare, _cc2008 [reprinted 2022]. |
||
300 |
_ax, 469 pages : _billustrations ; _c24 cm. |
||
490 | 1 |
_aDrugs and the pharmaceutical sciences ; _v185 |
|
504 | _aIncludes bibliographical references and index. | ||
505 | 0 | _aPharmaceutical 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. | |
505 | 0 | _aActive pharmaceutical ingredients / Max S. Lazar -- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham. | |
526 | _aPHR | ||
650 | 0 |
_aPharmacy _xLaw and legislation _zUnited States. _950825 |
|
650 | 0 |
_aDrugs _xLaw and legislation _zUnited States. _950826 |
|
650 | 1 | 2 |
_aLegislation, Drug _zUnited States. _950827 |
650 | 2 | 2 |
_aGuideline Adherence _xlegislation & jurisprudence _zUnited States. _950828 |
650 | 2 | 2 |
_aPharmaceutical Preparations _xstandards _zUnited States. _950829 |
650 | 2 | 2 |
_aPharmacy. _950830 |
700 | 1 |
_aBerry, Ira R., _d1942- _950831 |
|
700 | 1 |
_aMartin, Robert P. _q(Robert Paul) _950832 |
|
830 | 0 |
_aDrugs and the pharmaceutical sciences ; _vv. 185. _950833 |
|
852 |
_aAyesha Abed Library _cGeneral Stacks |
||
942 |
_2ddc _cBK |