Specification of drug substances and products :: development and validation of analytical methods /
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of a...
Gespeichert in:
| Weitere Verfasser: | , , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Amsterdam :
Elsevier,
[2014]
|
| Schriftenreihe: | Progress in pharmaceutical and biomedical analysis.
|
| Schlagworte: | |
| Online-Zugang: | Volltext Volltext |
| Zusammenfassung: | Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity. |
| Beschreibung: | 1 online resource (389 pages) : illustrations |
| Bibliographie: | Includes bibliographical references and index. |
| ISBN: | 9780080983431 008098343X |
Internformat
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| 505 | 0 | |a Part 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids. | |
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| 520 | |a Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity. | ||
| 650 | 0 | |a Drugs |x Analysis |x Methodology. | |
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| author2 | Riley, Christopher M. Rosanske, Thomas W. Riley, Shelley R. Rabel |
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| contents | Part 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids. |
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| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| id | ZDB-4-EBA-ocn861537317 |
| illustrated | Illustrated |
| indexdate | 2024-11-27T13:25:36Z |
| institution | BVB |
| isbn | 9780080983431 008098343X |
| language | English |
| oclc_num | 861537317 |
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| series | Progress in pharmaceutical and biomedical analysis. |
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| spelling | Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA. Amsterdam : Elsevier, [2014] ©2014 1 online resource (389 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier Progress in Pharmaceutical and Biomedical Analysis Includes bibliographical references and index. Part 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids. Online resource; title from PDF title page (ebrary, viewed October 8, 2013). Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity. Drugs Analysis Methodology. Pharmaceutical Preparations methods Pharmaceutical Preparations standards Médicaments Analyse Méthodologie. MEDICAL Pharmacology. bisacsh Drugs Analysis Methodology fast Riley, Christopher M. Rosanske, Thomas W. Riley, Shelley R. Rabel. Print version: Specification of drug substances and products. Amsterdam : Elsevier, 2014 9780080983509 (DLC) 2013444132 Progress in pharmaceutical and biomedical analysis. http://id.loc.gov/authorities/names/n88540690 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=486507 Volltext FWS01 ZDB-4-EBA FWS_PDA_EBA https://www.sciencedirect.com/science/book/9780080983509 Volltext |
| spellingShingle | Specification of drug substances and products : development and validation of analytical methods / Progress in pharmaceutical and biomedical analysis. Part 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids. Drugs Analysis Methodology. Pharmaceutical Preparations methods Pharmaceutical Preparations standards Médicaments Analyse Méthodologie. MEDICAL Pharmacology. bisacsh Drugs Analysis Methodology fast |
| title | Specification of drug substances and products : development and validation of analytical methods / |
| title_auth | Specification of drug substances and products : development and validation of analytical methods / |
| title_exact_search | Specification of drug substances and products : development and validation of analytical methods / |
| title_full | Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA. |
| title_fullStr | Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA. |
| title_full_unstemmed | Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA. |
| title_short | Specification of drug substances and products : |
| title_sort | specification of drug substances and products development and validation of analytical methods |
| title_sub | development and validation of analytical methods / |
| topic | Drugs Analysis Methodology. Pharmaceutical Preparations methods Pharmaceutical Preparations standards Médicaments Analyse Méthodologie. MEDICAL Pharmacology. bisacsh Drugs Analysis Methodology fast |
| topic_facet | Drugs Analysis Methodology. Pharmaceutical Preparations methods Pharmaceutical Preparations standards Médicaments Analyse Méthodologie. MEDICAL Pharmacology. Drugs Analysis Methodology |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=486507 https://www.sciencedirect.com/science/book/9780080983509 |
| work_keys_str_mv | AT rileychristopherm specificationofdrugsubstancesandproductsdevelopmentandvalidationofanalyticalmethods AT rosanskethomasw specificationofdrugsubstancesandproductsdevelopmentandvalidationofanalyticalmethods AT rileyshelleyrrabel specificationofdrugsubstancesandproductsdevelopmentandvalidationofanalyticalmethods |