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ICH quality guidelinesan implementat...

Elder, David

ICH quality guidelinesan implementation guide /

Record Type:	Electronic resources : Monograph/item
Title/Author:	ICH quality guidelinesedited by Andrew Teasdale, David Elder, Raymond W. Nims.
Reminder of title:	an implementation guide /
remainder title:	International Conference on Harmonization quality guidelines
other author:	Teasdale, Andrew.
Published:	Hoboken, NJ :John Wiley & Sons,2018.
Description:	1 online resource.
Subject:	Drug development.
Online resource:	https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147
ISBN:	9781118971147$q(electronic bk. ;$qoBook)

ICH quality guidelinesan implementation guide /
ICH quality guidelinesan implementation guide /[electronic resource] :International Conference on Harmonization quality guidelinesedited by Andrew Teasdale, David Elder, Raymond W. Nims. - 1st ed. - Hoboken, NJ :John Wiley & Sons,2018. - 1 online resource.

Includes bibliographical references and index.

"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"--Provided by publisher.

ISBN: 9781118971147$q(electronic bk. ;$qoBook)

LCCN: 2017014318Subjects--Topical Terms:

190608
Drug development.

LC Class. No.: RM301.25

Dewey Class. No.: 615.1/9

ICH quality guidelinesan implementation guide /
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245 0 0 $a ICH quality guidelines $h [electronic resource] : $b an implementation guide / $c edited by Andrew Teasdale, David Elder, Raymond W. Nims.
246 3 $a International Conference on Harmonization quality guidelines
250 $a 1st ed.
260 $a Hoboken, NJ : $b John Wiley & Sons, $c 2018.
300 $a 1 online resource.
504 $a Includes bibliographical references and index.
520 $a "Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"--Provided by publisher.
588 0 $a Print version record and CIP data provided by publisher; resource not viewed.
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650 0 $a Drugs $x Quality control. $3 303164
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700 1 $a Nims, Raymond W. $3 813302
856 4 0 $u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147