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100%: Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley: Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods (ISBN: 9780081013137) Elsevier Health Sciences, in Englisch.Nur diese Ausgabe anzeigen…
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57%: Van, Hanneke. Riley, Chirstopher M. Rosanke, Thomas W.: Development and Validation of Analytical Methods (Progress in Pharmaceutical and Biomedical Analysis) (Progress in Pharmaceutical and Biomedical Analysis) (ISBN: 9780080427928) in Englisch, Band: 3, Broschiert.Nur diese Ausgabe anzeigen…
Specification of Drug Substances and Products: Development and Validation of Analytical Methods
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Specification of Drug Substances and Products, Development and Validation of Analytical Methods (2013)
EN NW EBISBN: 9780080983431 bzw. 008098343X, in Englisch, Pergamon, neu, E-Book.
Lieferung aus: Niederlande, Direct beschikbaar.
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The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must ... The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6-12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.Soort: Met illustraties;Taal: Engels;Vertaald uit het: Engels;Formaat: ePub met kopieerbeveiliging (DRM) van Adobe;Kopieerrechten: Het kopiëren van (delen van) de pagina's is niet toegestaan ;Geschikt voor: Alle e-readers te koop bij bol.com (of compatible voor PDF of ePub). Telefoons en tablets met Google Android (1.6 of hoger) voorzien van bol.com boekenbol app. PC en Mac;Verschijningsdatum: augustus 2013;ISBN10: 008098343X;ISBN13: 9780080983431; Engelstalig | Ebook | 2013.
bol.com.
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must ... The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6-12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.Soort: Met illustraties;Taal: Engels;Vertaald uit het: Engels;Formaat: ePub met kopieerbeveiliging (DRM) van Adobe;Kopieerrechten: Het kopiëren van (delen van) de pagina's is niet toegestaan ;Geschikt voor: Alle e-readers te koop bij bol.com (of compatible voor PDF of ePub). Telefoons en tablets met Google Android (1.6 of hoger) voorzien van bol.com boekenbol app. PC en Mac;Verschijningsdatum: augustus 2013;ISBN10: 008098343X;ISBN13: 9780080983431; Engelstalig | Ebook | 2013.
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Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods
EN NWISBN: 9780081013137 bzw. 0081013132, in Englisch, Elsevier Science & Tech, neu.
Lieferung aus: Kanada, In Stock, plus shipping.
Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley, Books, Health and Well Being, 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 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 authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity.
Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley, Books, Health and Well Being, 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 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 authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity.
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Specification of Drug Substances and Products
EN NWISBN: 9780081013137 bzw. 0081013132, in Englisch, Elsevier Health Sciences, neu.
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Specification of Drug Substances and Products
EN NWISBN: 9780080983431 bzw. 008098343X, in Englisch, Elsevier, neu.
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Specification of Drug Substances and Products (2013)
EN NW EB DLISBN: 9780080983431 bzw. 008098343X, in Englisch, Pergamon; Pergamon Press, Vereinigte Staaten von Amerika, neu, E-Book, elektronischer Download.
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Specification of Drug Substances and Products, Development and Validation of Analytical Methods (2013)
EN HC NWISBN: 9780080983509 bzw. 0080983502, in Englisch, Elsevier Science &Amp; Technology, gebundenes Buch, neu.
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Gebr. - Specification of Drug Substances and Products: Development and Validation of Analytical Methods (2013)
EN NWISBN: 9780080983509 bzw. 0080983502, in Englisch, Pergamon; Pergamon Press, Vereinigte Staaten von Amerika, neu.
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Specification of Drug Substances and Products: Development and Validation of Analytical Methods (2013)
EN NW FE EB DLISBN: 9780080983431 bzw. 008098343X, in Englisch, 390 Seiten, Elsevier, neu, Erstausgabe, E-Book, elektronischer Download.
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Specification of Drug Substances and Products: Development and Validation of Analytical Methods (2013)
EN NW FE EB DLISBN: 9780080983431 bzw. 008098343X, in Englisch, 390 Seiten, Elsevier, neu, Erstausgabe, E-Book, elektronischer Download.
Lieferung aus: Vereinigtes Königreich Großbritannien und Nordirland, ebook for download, Free shipping.
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