MARC Record from Scriblio

LEADER: 02358cam 22003858a 4500
001 2005019187
003 DLC
005 20050919074542.0
008 050706s2006 ctu b 001 0 eng
010 $a 2005019187
020 $a027598141X (alk. paper)
035 $a(DNLM)101251830
040 $aDNLM/DLC$cDLC$dDLC
042 $apcc
050 00 $aRM301.25$b.S34 2006
060 10 $aQV 736$bS291n 2006
082 00 $a615/.19$222
100 1 $aSchacter, Bernice Zeldin,$d1943-
245 14 $aThe new medicines :$bhow drugs are created, approved, marketed, and sold /$cBernice Schacter.
260 $aWestport, Conn. :$bPraeger Publishers,$c2006.
263 $a0512
300 $ap. ;$ccm.
504 $aIncludes bibliographical references and index.
505 0 $aThe path from bench to bedside -- How did the FDA get to be in charge? The history of regulation of human drugs -- The eureka moment: how new medicines are discovered -- Test tube results are not enough: animal tests for a drug's utility -- The business decisions: committing to development -- Production of the new drug -- Laboratory and animal safety testing -- Getting set for clinical trials -- Phase 1 clinical trials -- Phase 2 clinical testing -- Phase 3 testing -- Putting together the application for approval: the new drug application (NDA) -- Now everybody holds their breath (and some people may brush up on the rules for insider trading), will the FDA file the NDA? -- The FDA review -- What do outside experts think? The advisory committee meeting and FDA approval -- The launch-marketing the drug -- It's not over till it's over: post approval studies -- Are we (well) served? Do we have the system of industry and regulations we need want and may deserve.
650 0 $aDrug development$vPopular works.
650 0 $aClinical trials$vPopular works.
650 0 $aPharmaceutical industry$vPopular works.
650 0 $aConsumer education.
650 12 $aDrug Industry$xorganization & administration$zUnited States.
650 12 $aPharmaceutical Preparations$xeconomics$zUnited States.
650 22 $aClinical Trials$zUnited States.
650 22 $aDrug Design$zUnited States.
650 22 $aDrugs, Investigational$xeconomics$zUnited States.
650 22 $aLegislation, Drug$zUnited States.
856 41 $3Table of contents$uhttp://www.loc.gov/catdir/toc/ecip0515/2005019187.html