國立虎尾科技大學 |

ICH quality guidelines = an implementation guide /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	ICH quality guidelines/ edited by Andrew Teasdale, David Elder, Raymond W. Nims.
其他題名:	an implementation guide /
其他題名:	International Conference on Harmonization quality guidelines
其他作者:	Teasdale, Andrew.
出版者:	Hoboken, NJ :John Wiley & Sons, : 2018.,
面頁冊數:	1 online resource.
標題:	Drug development. -
電子資源:	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:

581824
Drug development.

LC Class. No.: RM301.25

Dewey Class. No.: 615.1/9

ICH quality guidelines = an implementation guide /
LDR:02162cam a2200325 a 4500 001 907900
005 20180302170833.0
006 m o d
007 cr |||||||||||
008 190510s2018 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 581824
650 0 $a Drugs $x Testing. $3 581825
650 0 $a Drugs $x Quality control. $3 583775
700 1 $a Teasdale, Andrew. $3 1177546
700 1 $a Elder, David $q (David P.) $3 1177547
700 1 $a Nims, Raymond W. $3 1177548
856 4 0 $u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147