000 | 02398nam a2200373Ia 4500 | ||
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001 | CRC0KE12014PDF | ||
003 | FlBoTFG | ||
005 | 20171224123444.0 | ||
006 | m|||||o||d|||||||| | ||
007 | cr|||| | ||
008 | 120530s2012 fluad sb 001 0 eng d | ||
020 | _a9781439845684 (ebook : PDF) | ||
040 |
_aFlBoTFG _cFlBoTFG |
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090 |
_aRM301.25 _b.G33 2012 |
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092 |
_a615.704 _bG123 |
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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 |