Method validation in pharmaceutical analysis: a guide to best practice
Saved in:
| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
Weinheim
Wiley-VCH
[2014]
|
| Edition: | Second, completely revised and updated edition |
| Subjects: | |
| Online Access: | FRO01 UBG01 Volltext |
| Item Description: | Includes bibliographical references and index This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regul |
| Physical Description: | 1 Online-Ressource |
| ISBN: | 9783527672196 3527672192 9783527672202 3527672206 9783527335633 3527335633 |
Staff View
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| dewey-full | 615.1901 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | Second, completely revised and updated edition |
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| language | English |
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| spelling | Method validation in pharmaceutical analysis a guide to best practice edited by Joachim Ermer and Phil Nethercote Second, completely revised and updated edition Weinheim Wiley-VCH [2014] 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regul Drugs / Analysis Methodology / Validity Pharmacology MEDICAL / Pharmacology bisacsh Medizin Validität (DE-588)4062305-1 gnd rswk-swf Pharmazeutische Analyse (DE-588)4174139-0 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Pharmazeutische Analyse (DE-588)4174139-0 s Validität (DE-588)4062305-1 s 2\p DE-604 Ermer, Joachim Sonstige oth Nethercote, Phil Sonstige oth https://onlinelibrary.wiley.com/doi/book/10.1002/9783527672202 Verlag URL des Erstveröffentlichers Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Method validation in pharmaceutical analysis a guide to best practice Drugs / Analysis Methodology / Validity Pharmacology MEDICAL / Pharmacology bisacsh Medizin Validität (DE-588)4062305-1 gnd Pharmazeutische Analyse (DE-588)4174139-0 gnd |
| subject_GND | (DE-588)4062305-1 (DE-588)4174139-0 (DE-588)4143413-4 |
| title | Method validation in pharmaceutical analysis a guide to best practice |
| title_auth | Method validation in pharmaceutical analysis a guide to best practice |
| title_exact_search | Method validation in pharmaceutical analysis a guide to best practice |
| title_full | Method validation in pharmaceutical analysis a guide to best practice edited by Joachim Ermer and Phil Nethercote |
| title_fullStr | Method validation in pharmaceutical analysis a guide to best practice edited by Joachim Ermer and Phil Nethercote |
| title_full_unstemmed | Method validation in pharmaceutical analysis a guide to best practice edited by Joachim Ermer and Phil Nethercote |
| title_short | Method validation in pharmaceutical analysis |
| title_sort | method validation in pharmaceutical analysis a guide to best practice |
| title_sub | a guide to best practice |
| topic | Drugs / Analysis Methodology / Validity Pharmacology MEDICAL / Pharmacology bisacsh Medizin Validität (DE-588)4062305-1 gnd Pharmazeutische Analyse (DE-588)4174139-0 gnd |
| topic_facet | Drugs / Analysis Methodology / Validity Pharmacology MEDICAL / Pharmacology Medizin Validität Pharmazeutische Analyse Aufsatzsammlung |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9783527672202 |
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