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008 120530s2012 fluad sb 001 0 eng d
020 _a9781439845684 (ebook : PDF)
040 _aFlBoTFG
_cFlBoTFG
090 _aRM301.25
_b.G33 2012
092 _a615.704
_bG123
100 1 _aGad, Shayne C.,
_d1948-
245 1 0 _aSafety pharmacology in pharmaceutical development
_h[electronic resource] :
_bapproval and post marketing surveillance /
_cShayne C. Gad.
250 _a2nd ed.
260 _aBoca Raton, Fla. :
_bCRC Press,
_c2012.
300 _axv, 197 p. :
_bill.
500 _aRev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.
504 _aIncludes bibliographical references and index.
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.
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.
530 _aAlso available in print edition.
538 _aMode of access: World Wide Web.
650 0 _aDrug development.
650 0 _aDrug approval.
650 0 _aPharmacology.
655 7 _aElectronic books.
_2lcsh
700 1 _aGad, Shayne C.,
_d1948-
_tSafety pharmacology in pharmaceutical development and approval.
776 1 _z9781439845677 (hardback : alk. paper)
856 4 0 _uhttp://marc.crcnetbase.com/isbn/9781439845684
_qapplication/PDF
_zDistributed by publisher. Purchase or institutional license may be required for access.
999 _c15015
_d15015