02312nam a2200373Ia 4500001001500000003000900015005001700024006001900041007000700060008004100067020003200108040002300140090002400163092001800187100002700205245013900232250001200371260004200383300002300425500008800448504005100536505037300587520060000960530003701560538003601597650002201633650001901655650001801674655002801692700009201720776004201812856006701854999001701921CRC0KE12014PDFBD-DhSAU20151012144305.0m|||||o||d||||||||cr||||120530s2012    fluad   sb    001 0 eng d  a9781439845684 (ebook : PDF)  aBD-DhSAUcBD-DhSAU  aRM301.25b.G33 2012  a615.704bG1231 aGad, Shayne C.,d1948-10aSafety pharmacology in pharmaceutical developmenth[electronic resource] :bapproval and post marketing surveillance /cShayne C. Gad.  a2nd ed.  aBoca Raton, Fla. :bCRC Press,c2012.  axv, 197 p. :bill.  aRev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.  aIncludes bibliographical references and index.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.  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.  aAlso available in print edition.  aMode of access: World Wide Web. 0aDrug development. 0aDrug approval. 0aPharmacology. 7aElectronic books.2lcsh1 aGad, Shayne C.,d1948-tSafety pharmacology in pharmaceutical development and approval.1 z9781439845677 (hardback : alk. paper)40uhttp://marc.crcnetbase.com/isbn/9781439845684qapplication/PDF  c11737d11736