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A history of a cGMP medical event investigation[electronic resource] /

Record Type:	Language materials, printed : Monograph/item
[NT 15000414]:	615.58
Title/Author:	A history of a cGMP medical event investigation/ Michael A. Brown.
Author:	Brown, Michael A.,
Published:	Hoboken, N.J. : : John Wiley & Sons,, c2013.
Description:	1 online resource (253 p.)
Subject:	Adverse Drug Reaction Reporting Systems - United States.
Subject:	Drug Therapy - adverse effects - United States.
Subject:	Investigational New Drug Application - United States.
Subject:	Drugs - Side effects.
ISBN:	9781118494943 (electronic bk.)
ISBN:	1118494946 (electronic bk.)
ISBN:	9781118494936 (electronic bk.)
ISBN:	1118494938 (electronic bk.)
ISBN:	9781118494882 (electronic bk.)
ISBN:	1118494881 (electronic bk.)
[NT 15000227]:	Includes bibliographical references and index.
[NT 15000229]:	Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: [1] FDA Investigational and New Drug Application Processes, [2] FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP), [3] ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.
Online resource:	http://onlinelibrary.wiley.com/book/10.1002/9781118494943

A history of a cGMP medical event investigation[electronic resource] /
Brown, Michael A.,1945-

A history of a cGMP medical event investigation[electronic resource] /Michael A. Brown. - Hoboken, N.J. :John Wiley & Sons,c2013. - 1 online resource (253 p.)

Includes bibliographical references and index.

Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: [1] FDA Investigational and New Drug Application Processes, [2] FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP), [3] ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.

ISBN: 9781118494943 (electronic bk.)Subjects--Corporate Names:

448067
United States.
Food and Drug Administration.Subjects--Topical Terms:

622945
Adverse Drug Reaction Reporting Systems
--United States.

LC Class. No.: RM302.5 / .B76 2013

Dewey Class. No.: 615.58

National Library of Medicine Call No.: QV 26.5 / B76 2013

A history of a cGMP medical event investigation[electronic resource] /
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020 $a 1118494938 (electronic bk.)
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020 $z 1118396618 (paper)
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245 1 2 $a A history of a cGMP medical event investigation $h [electronic resource] / $c Michael A. Brown.
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300 $a 1 online resource (253 p.)
504 $a Includes bibliographical references and index.
520 $a Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: [1] FDA Investigational and New Drug Application Processes, [2] FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP), [3] ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.
588 $a Description based on print version record.
610 1 2 $a United States. $b Food and Drug Administration. $3 448067
650 1 2 $a Adverse Drug Reaction Reporting Systems $z United States. $3 622945
650 2 2 $a Drug Therapy $x adverse effects $z United States. $3 622946
650 2 2 $a Investigational New Drug Application $z United States. $3 622947
650 0 $a Drugs $x Side effects. $3 489494
856 4 0 $u http://onlinelibrary.wiley.com/book/10.1002/9781118494943