東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

ICH quality guidelines = an implemen...

Teasdale, Andrew.

Linked to FindBook

Google Book

Amazon

博客來

ICH quality guidelines = an implementation guide /

Record Type:	Electronic resources : Monograph/item
Title/Author:	ICH quality guidelines/ edited 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

ICH quality guidelines = an 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

LCCN: 2017014318Subjects--Topical Terms:

716904
Drug development.

LC Class. No.: RM301.25

Dewey Class. No.: 615.1/9

ICH quality guidelines = an implementation guide /
LDR:02162cmm a2200325 a 4500 001 2141100
005 20180302170833.0
006 m o d
007 cr |||||||||||
008 181211s2018 nju ob 001 0 eng
010 $a 2017014318
020 $a 9781118971147 $q (electronic bk. ; $q oBook)
020 $a 1118971140 $q (electronic bk. ; $q oBook)
020 $a 9781118971123 $q (pdf)
020 $a 1118971124 $q (pdf)
020 $a 9781118971130 $q (epub)
020 $a 1118971132 $q (epub)
020 $z 9781118971116 $q (hardback)
035 $a 002599284
040 $a DLC $b eng $c DLC $d OCLCO $d OCLCQ $d OCLCF $d UIU $d N $d DG1 $d IDEBK $d MERER $d OCLCQ $d UPM
050 1 0 $a RM301.25
082 0 0 $a 615.1/9 $2 23
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.
650 0 $a Drug development. $3 716904
650 0 $a Drugs $x Testing. $3 646233
650 0 $a Drugs $x Quality control. $3 916808
700 1 $a Teasdale, Andrew. $3 3318905
700 1 $a Elder, David $q (David P.) $3 3318906
700 1 $a Nims, Raymond W. $3 3318907
856 4 0 $u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147