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Safety pharmacology in pharmaceutica...

Gad, Shayne C., (1948-)

Safety pharmacology in pharmaceutical development[electronic resource] :approval and post marketing surveillance /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615.7/04
書名/作者:	Safety pharmacology in pharmaceutical development : approval and post marketing surveillance // Shayne C. Gad.
作者:	Gad, Shayne C.,
其他作者:	Gad, Shayne C.,
出版者:	Boca Raton, FL : : CRC Press,, c2012.
面頁冊數:	1 online resource (xv, 197 p.) : : ill.
附註:	Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.
標題:	Drugs - Toxicology.
標題:	Drugs - Safety measures.
標題:	Drug development - Safety measures.
標題:	Drug Evaluation, Preclinical.
標題:	Drug Approval.
標題:	Product Surveillance, Postmarketing.
標題:	Toxicity Tests.
ISBN:	9781439845684 (electronic bk.)
書目註:	Includes bibliographical references and index.
內容註:	Safety pharmacology: background, history, issues and concerns -- Regulatory requirements: ICH, FDA, EMA, and Japan -- Principles of screening and study design -- Cardiovascular system -- Central nervous system -- Respiratory system -- Renal function -- Gastrointestinal system -- Immune system.
摘要、提要註:	"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.
電子資源:	http://www.crcnetbase.com/isbn/9781439845684

Safety pharmacology in pharmaceutical development[electronic resource] :approval and post marketing surveillance /
Gad, Shayne C.,1948-

Safety pharmacology in pharmaceutical developmentapproval and post marketing surveillance /[electronic resource] :Shayne C. Gad. - 2nd ed. - Boca Raton, FL :CRC Press,c2012. - 1 online resource (xv, 197 p.) :ill.

Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.

Includes bibliographical references and index.

Safety pharmacology: background, history, issues and concerns -- Regulatory requirements: ICH, FDA, EMA, and Japan -- Principles of screening and study design -- Cardiovascular system -- Central nervous system -- Respiratory system -- Renal function -- Gastrointestinal system -- Immune system.

"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.

ISBN: 9781439845684 (electronic bk.)

LCCN: 2012009446Subjects--Topical Terms:

431493
Drugs
--Toxicology.

LC Class. No.: RA1238 / .G333 2012

Dewey Class. No.: 615.7/04

National Library of Medicine Call No.: 2012 F-386

Safety pharmacology in pharmaceutical development[electronic resource] :approval and post marketing surveillance /
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100 1 $a Gad, Shayne C., $d 1948- $t Safety evaluation of medical devices. $3 438445
245 1 0 $a Safety pharmacology in pharmaceutical development $h [electronic resource] : $b approval and post marketing surveillance / $c Shayne C. Gad.
250 $a 2nd ed.
260 $a Boca Raton, FL : $b CRC Press, $c c2012.
300 $a 1 online resource (xv, 197 p.) : $b ill.
500 $a Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.
504 $a Includes bibliographical references and index.
505 0 $a Safety pharmacology: background, history, issues and concerns -- Regulatory requirements: ICH, FDA, EMA, and Japan -- Principles of screening and study design -- Cardiovascular system -- Central nervous system -- Respiratory system -- Renal function -- Gastrointestinal system -- 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.
588 $a Description based on print version record.
650 0 $a Drugs $x Toxicology. $3 431493
650 0 $a Drugs $x Safety measures. $3 519074
650 0 $a Drug development $x Safety measures. $3 657343
650 1 2 $a Drug Evaluation, Preclinical. $3 431418
650 2 2 $a Drug Approval. $3 553525
650 2 2 $a Product Surveillance, Postmarketing. $3 520490
650 2 2 $a Toxicity Tests. $3 437991
700 1 $a Gad, Shayne C., $d 1948- $t Safety evaluation of medical devices. $3 438445
856 4 0 $u http://www.crcnetbase.com/isbn/9781439845684

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