Accelerated predictive stability (APS): fundamentals and pharmaceutical industry practices
"Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study...
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| Weitere Verfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
London, United Kingdom
Academic Press, an imprint of Elsevier
2018
|
| Schlagworte: | |
| Online-Zugang: | FAW01 Volltext |
| Zusammenfassung: | "Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly.Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS)Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studiesCovers up-to-date regulatory experience"-- |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | 1 online resource |
| ISBN: | 9780128027851 0128027851 |
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| 245 | 1 | 0 | |a Accelerated predictive stability (APS) |b fundamentals and pharmaceutical industry practices |c edited by Fenghe Qiu, Garry Scrivens |
| 264 | 1 | |a London, United Kingdom |b Academic Press, an imprint of Elsevier |c 2018 | |
| 300 | |a 1 online resource | ||
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| 500 | |a Includes bibliographical references and index | ||
| 520 | |a "Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly.Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS)Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studiesCovers up-to-date regulatory experience"-- | ||
| 650 | 7 | |a MEDICAL / Pharmacology |2 bisacsh | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 650 | 7 | |a Prediction theory |2 fast | |
| 650 | 4 | |a Drug Industry / standards | |
| 650 | 4 | |a Drug Stability | |
| 650 | 4 | |a Drug stability |x Statistical methods | |
| 650 | 4 | |a Pharmaceutical industry | |
| 650 | 4 | |a Prediction theory | |
| 700 | 1 | |a Qiu, Fenghe |4 edt | |
| 700 | 1 | |a Scrivens, Garry |4 edt | |
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Datensatz im Suchindex
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| any_adam_object | |
| author2 | Qiu, Fenghe Scrivens, Garry |
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| building | Verbundindex |
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| dewey-full | 615.1 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1 |
| dewey-search | 615.1 |
| dewey-sort | 3615.1 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Electronic eBook |
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| id | DE-604.BV045383112 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:16:39Z |
| institution | BVB |
| isbn | 9780128027851 0128027851 |
| language | English |
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| publishDate | 2018 |
| publishDateSearch | 2018 |
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| publisher | Academic Press, an imprint of Elsevier |
| record_format | marc |
| spelling | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices edited by Fenghe Qiu, Garry Scrivens London, United Kingdom Academic Press, an imprint of Elsevier 2018 1 online resource txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index "Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly.Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS)Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studiesCovers up-to-date regulatory experience"-- MEDICAL / Pharmacology bisacsh Pharmaceutical industry fast Prediction theory fast Drug Industry / standards Drug Stability Drug stability Statistical methods Pharmaceutical industry Prediction theory Qiu, Fenghe edt Scrivens, Garry edt Erscheint auch als Druck-Ausgabe 9780128027868 Erscheint auch als Druck-Ausgabe 012802786X https://www.sciencedirect.com/science/book/9780128027868 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices MEDICAL / Pharmacology bisacsh Pharmaceutical industry fast Prediction theory fast Drug Industry / standards Drug Stability Drug stability Statistical methods Pharmaceutical industry Prediction theory |
| title | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices |
| title_auth | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices |
| title_exact_search | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices |
| title_full | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices edited by Fenghe Qiu, Garry Scrivens |
| title_fullStr | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices edited by Fenghe Qiu, Garry Scrivens |
| title_full_unstemmed | Accelerated predictive stability (APS) fundamentals and pharmaceutical industry practices edited by Fenghe Qiu, Garry Scrivens |
| title_short | Accelerated predictive stability (APS) |
| title_sort | accelerated predictive stability aps fundamentals and pharmaceutical industry practices |
| title_sub | fundamentals and pharmaceutical industry practices |
| topic | MEDICAL / Pharmacology bisacsh Pharmaceutical industry fast Prediction theory fast Drug Industry / standards Drug Stability Drug stability Statistical methods Pharmaceutical industry Prediction theory |
| topic_facet | MEDICAL / Pharmacology Pharmaceutical industry Prediction theory Drug Industry / standards Drug Stability Drug stability Statistical methods |
| url | https://www.sciencedirect.com/science/book/9780128027868 |
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