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ICH quality guidelinesan implementat...

Elder, David

ICH quality guidelinesan implementation guide /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	ICH quality guidelinesedited 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$q(electronic bk. ;$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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