ICH quality guidelines: an implementation guide
"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 interpr...
Gespeichert in:
| Weitere Verfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, NJ
Wiley
2018
|
| Schlagworte: | |
| Online-Zugang: | FRO01 |
| Zusammenfassung: | "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)"-- |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | xi, 721 Seiten Illustrationen, Diagramme |
| ISBN: | 9781118971116 |
Internformat
MARC
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| 245 | 1 | 0 | |a ICH quality guidelines |b an implementation guide |c edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| 246 | 1 | 3 | |a International Conference on Harmonization quality guidelines |
| 264 | 1 | |a Hoboken, NJ |b Wiley |c 2018 | |
| 300 | |a xi, 721 Seiten |b Illustrationen, Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |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)"-- | ||
| 650 | 4 | |a MEDICAL / Pharmacology / bisacsh | |
| 650 | 4 | |a TECHNOLOGY & ENGINEERING / Quality Control / bisacsh | |
| 650 | 4 | |a SCIENCE / Chemistry / Industrial & Technical / bisacsh | |
| 650 | 4 | |a Drug development / fast / (OCoLC)fst00898670 | |
| 650 | 4 | |a Drugs / Quality control / fast / (OCoLC)fst00898891 | |
| 650 | 4 | |a Drugs / Testing / fast / (OCoLC)fst00898940 | |
| 650 | 4 | |a Drug development | |
| 650 | 4 | |a Drugs / Testing | |
| 650 | 4 | |a Drugs / Quality control | |
| 700 | 1 | |a Teasdale, Anthony |d 1957- |0 (DE-588)170666131 |4 edt | |
| 700 | 1 | |a Elder, David |4 edt | |
| 700 | 1 | |a Nims, Raymond W. |4 edt | |
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Datensatz im Suchindex
| _version_ | 1804178532721491968 |
|---|---|
| any_adam_object | |
| author2 | Teasdale, Anthony 1957- Elder, David Nims, Raymond W. |
| author2_role | edt edt edt |
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| author_GND | (DE-588)170666131 |
| author_facet | Teasdale, Anthony 1957- Elder, David Nims, Raymond W. |
| building | Verbundindex |
| bvnumber | BV044945481 |
| classification_rvk | VX 5500 |
| ctrlnum | (OCoLC)1039776187 (DE-599)BVBBV044945481 |
| dewey-full | 615.1/9 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1/9 |
| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Book |
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| id | DE-604.BV044945481 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T08:05:28Z |
| institution | BVB |
| isbn | 9781118971116 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-030338320 |
| oclc_num | 1039776187 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | xi, 721 Seiten Illustrationen, Diagramme |
| psigel | ZDB-35-WIC FRO_PDA_WIC |
| publishDate | 2018 |
| publishDateSearch | 2018 |
| publishDateSort | 2018 |
| publisher | Wiley |
| record_format | marc |
| spelling | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) International Conference on Harmonization quality guidelines Hoboken, NJ Wiley 2018 xi, 721 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier 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)"-- MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control Teasdale, Anthony 1957- (DE-588)170666131 edt Elder, David edt Nims, Raymond W. edt Erscheint auch als Online-Ausgabe, EPUB 978-1-118-97113-0 Erscheint auch als Online-Ausgabe, PDF 978-1-118-97112-3 |
| spellingShingle | ICH quality guidelines an implementation guide MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
| title | ICH quality guidelines an implementation guide |
| title_alt | International Conference on Harmonization quality guidelines |
| title_auth | ICH quality guidelines an implementation guide |
| title_exact_search | ICH quality guidelines an implementation guide |
| title_full | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_fullStr | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_full_unstemmed | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_short | ICH quality guidelines |
| title_sort | ich quality guidelines an implementation guide |
| title_sub | an implementation guide |
| topic | MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
| topic_facet | MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
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