Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 35
Book Description
International Symposium on Laboratory Automation and Robotics 1992
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 35
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 35
Book Description
Special Issue--International Symposium on Laboratory Automation and Robotics 1992
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 33
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 33
Book Description
Proceedings of the International Symposium on Laboratory Automation and Robotics 1992
Author: James N. Little
Publisher:
ISBN: 9780931565106
Category : Automation
Languages : en
Pages : 791
Book Description
Publisher:
ISBN: 9780931565106
Category : Automation
Languages : en
Pages : 791
Book Description
Automation in the Laboratory
Author: William Jeffrey Hurst
Publisher: John Wiley & Sons
ISBN: 9781560810254
Category : Science
Languages : en
Pages : 282
Book Description
Publisher: John Wiley & Sons
ISBN: 9781560810254
Category : Science
Languages : en
Pages : 282
Book Description
Development and Validation of Analytical Methods
Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 0080530354
Category : Science
Languages : en
Pages : 363
Book Description
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.
Publisher: Elsevier
ISBN: 0080530354
Category : Science
Languages : en
Pages : 363
Book Description
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.
Proceedings of the First International Symposium on Robotics, Automation and Artificial Intelligence Applied to Analytical Chemistry, Montreux, Switzerland, 26-28 February 1992
Author: Jan van der Greef
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Proceedings of the First International Symposium on Robotics, Automation and Artificial Intelligence Applied to Analytical Chemistry
Author: International Symposium on Robotics, Automation and Artificial Intelligence Applied to Analytical Chemistry
Publisher:
ISBN:
Category :
Languages : en
Pages : 162
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 162
Book Description
Proceedings of the First International Symposium on Robotics, Automation and Artificial Intelligence Applied to Analytical Chemistry, Montreux, Switserland, 26-28 February 1992
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Proceedings of the First International Symposium on Automation, Robotics and Artificial Intelligence Applied to Analytical Chemistry
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
High Throughput Screening
Author: John P. Devlin
Publisher: CRC Press
ISBN: 9780824700676
Category : Science
Languages : en
Pages : 704
Book Description
Furnishing the latest interdisciplinary information on the most important and frequently the only investigational system available for discovery programs that address the effects of small molecules on newly discovered enzyme and receptor targets emanating from molecular biology, this timely resource facilitates the transition from classical to high throughput screening (HTS) systems and provides a solid foundation for the implementation and development of HTS in bio-based industries and associated academic environments.
Publisher: CRC Press
ISBN: 9780824700676
Category : Science
Languages : en
Pages : 704
Book Description
Furnishing the latest interdisciplinary information on the most important and frequently the only investigational system available for discovery programs that address the effects of small molecules on newly discovered enzyme and receptor targets emanating from molecular biology, this timely resource facilitates the transition from classical to high throughput screening (HTS) systems and provides a solid foundation for the implementation and development of HTS in bio-based industries and associated academic environments.