MARC Record from Library of Congress

LEADER: 03555cam a22004214a 4500
001 2008042661
003 DLC
005 20090106105846.0
008 080926s2008 nyua b 001 0 eng
010 $a 2008042661
016 7 $a101485457$2DNLM
020 $a9781420070422 (hardcover : alk. paper)
020 $a1420070428 (hardcover : alk. paper)
035 $a(OCoLC)ocn259902129
035 $a(OCoLC)259902129$z(OCoLC)166379234
040 $aDNLM/DLC$cDLC$dBTCTA$dBAKER$dYDXCP$dNLM$dC#P$dBWX$dDLC
042 $apcc
043 $an-us---
050 00 $aKF2036.D7$bP47 2008
060 00 $aW1$bDR893B v.185 2008
060 10 $aQV 33 AA1$bP5365 2008
082 00 $a344.7304/233$222
245 04 $aThe pharmaceutical regulatory process /$cedited by Ira R. Berry, Robert P. Martin.
250 $a2nd ed.
260 $aNew York :$bInforma Healthcare,$cc2008.
300 $ax, 469 p. :$bill. ;$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.
650 0 $aPharmacy$xLaw and legislation$zUnited States.
650 0 $aDrugs$xLaw and legislation$zUnited States.
650 12 $aLegislation, Drug$zUnited States.
650 22 $aGuideline Adherence$xlegislation & jurisprudence$zUnited States.
650 22 $aPharmaceutical Preparations$xstandards$zUnited States.
700 1 $aBerry, Ira R.,$d1942-
700 1 $aMartin, Robert P.$q(Robert Paul)
830 0 $aDrugs and the pharmaceutical sciences ;$vv. 185.