MARC Record from harvard_bibliographic_metadata

LEADER: 02664cam a2200493 a 4500
001 013336565-4
005 20121005190119.0
008 120305s2012 flua b 001 0 eng
010 $a 2012009446
015 $aGBB1D1831$2bnb
016 7 $a101579512$2DNLM
016 7 $a015969770$2Uk
020 $a9781439845677 (hardback : alk. paper)
020 $a1439845670 (hardback : alk. paper)
020 $a9781439845684 (ebook)
020 $a1439845689 (ebook)
035 0 $aocn761380929
040 $aDNLM/DLC$beng$cDLC$dYDX$dNLM$dUKMGB$dYDXCP$dOCLCO$dZWZ$dCDX
042 $apcc
050 4 $aRA1238$b.G333 2012
060 00 $a2012 F-386
060 10 $aQV 771
082 00 $a615.7/04$223
100 1 $aGad, Shayne C.,$d1948-
245 10 $aSafety pharmacology in pharmaceutical development :$bapproval and post marketing surveillance /$cShayne C. Gad.
250 $a2nd ed.
260 $aBoca Raton, FL :$bCRC Press,$cc2012.
300 $axv, 197 p. :$bill. ;$c24 cm.
500 $aRev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.
504 $aIncludes bibliographical references and index.
520 $a"This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs, from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international especially Europe and Japan) and updated test methods, interpretation, and science"--Provided by publisher.
505 0 $aCh. 1. Safety pharmacology : background, history, issues, and concerns -- ch. 2. Regulatory requirements : ICH, FDA, EMA, and Japan -- ch. 3. Principles of screening and study design -- ch. 4. Cardiovascular system -- ch. 5. Central nervous system -- ch. 6. Respiratory system -- ch. 7. Renal function -- ch. 8. The gastrointestinal system -- ch. 9. The immune system.
650 22 $aToxicity Tests.
650 22 $aProduct Surveillance, Postmarketing.
650 22 $aDrug Approval.
650 12 $aDrug Evaluation, Preclinical.
650 0 $aDrugs$xToxicology.
650 0 $aDrugs$xSafety measures.
650 0 $aDrug development$xSafety measures.
650 7 $aMédicaments$xToxicologie.$2ram
650 7 $aMédicaments$xMesures de sécurité.$2ram
700 1 $aGad, Shayne C.,$d1948-$tSafety pharmacology in pharmaceutical development and approval.
988 $a20120824
906 $0OCLC