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Safety pharmacology in pharmaceutical development = approval and post marketing surveillance /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Safety pharmacology in pharmaceutical development/ Shayne C. Gad.
其他題名:	approval and post marketing surveillance /
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:	Toxicity Tests. -
電子資源:	https://www.taylorfrancis.com/books/9780429107634
ISBN:	9781439845684 (electronic bk.)

Safety pharmacology in pharmaceutical development = 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:

582262
Toxicity Tests.

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 = approval and post marketing surveillance /
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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 2 2 $a Toxicity Tests. $3 582262
650 2 2 $a Product Surveillance, Postmarketing. $3 966134
650 2 2 $a Drug Approval. $3 582925
650 1 2 $a Drug Evaluation, Preclinical. $3 581967
650 0 $a Drug development $x Safety measures. $3 1029736
650 0 $a Drugs $x Safety measures. $3 582795
650 0 $a Drugs $x Toxicology. $3 582924
700 1 $a Gad, Shayne C., $d 1948- $3 582254
856 4 0 $u https://www.taylorfrancis.com/books/9780429107634