Author: William Jeffrey Hurst
Publisher: John Wiley & Sons
ISBN: 9781560810254
Category : Science
Languages : en
Pages : 282
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.
Index of Conference Proceedings
Author: British Library. Document Supply Centre
Publisher:
ISBN:
Category : Congresses and conventions
Languages : en
Pages : 860
Book Description
Publisher:
ISBN:
Category : Congresses and conventions
Languages : en
Pages : 860
Book Description
Polyurethanes Conference 2000
Author: Api
Publisher: CRC Press
ISBN: 9781587160387
Category : Technology & Engineering
Languages : en
Pages : 642
Book Description
Conference proceedings from 'Defining the Future Through Technology- Polyurethanes', held in Westin Copley Place, Boston, Massachusetts, on October 8-11 2000. Sponsored by the Alliance for the Polyurethanes Industry.
Publisher: CRC Press
ISBN: 9781587160387
Category : Technology & Engineering
Languages : en
Pages : 642
Book Description
Conference proceedings from 'Defining the Future Through Technology- Polyurethanes', held in Westin Copley Place, Boston, Massachusetts, on October 8-11 2000. Sponsored by the Alliance for the Polyurethanes Industry.
High Throughput Screening
Author: John P. Devlin
Publisher: CRC Press
ISBN: 1482269805
Category : Medical
Languages : en
Pages : 700
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
Publisher: CRC Press
ISBN: 1482269805
Category : Medical
Languages : en
Pages : 700
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
Robotics Research
Author: Georges Giralt
Publisher: Springer Science & Business Media
ISBN: 1447110218
Category : Technology & Engineering
Languages : en
Pages : 650
Book Description
This publication covers all the topics which are relevant to Advanced Robotics today, ranging from Systems Design to Reasoning and Planning. It is based on the Seventh International Symposium on Robotics Research held in Germany on October, 21 - 24th, 1995. The papers were written by specialists in the field from the United States, Europe, Japan, Australia and Canada. The editors, who also chaired this symposium, present the latest research results as well as new approaches to long standing problems. Robotics Research is a contribution to the emerging concepts, methods and tools that shape Robotics. The papers range from pure research reports to application-oriented studies. The topics covered include: manipulation, control, virtual reality, motion planning, 3D vision and industrial systems' issues.
Publisher: Springer Science & Business Media
ISBN: 1447110218
Category : Technology & Engineering
Languages : en
Pages : 650
Book Description
This publication covers all the topics which are relevant to Advanced Robotics today, ranging from Systems Design to Reasoning and Planning. It is based on the Seventh International Symposium on Robotics Research held in Germany on October, 21 - 24th, 1995. The papers were written by specialists in the field from the United States, Europe, Japan, Australia and Canada. The editors, who also chaired this symposium, present the latest research results as well as new approaches to long standing problems. Robotics Research is a contribution to the emerging concepts, methods and tools that shape Robotics. The papers range from pure research reports to application-oriented studies. The topics covered include: manipulation, control, virtual reality, motion planning, 3D vision and industrial systems' issues.
Annual Reports in Combinatorial Chemistry and Molecular Diversity
Author: W.H. Moos
Publisher: Springer Science & Business Media
ISBN: 9789072199232
Category : Medical
Languages : en
Pages : 376
Book Description
Combinatorial chemistry and molecular diversity approaches to scientific inquiry and novel product R&D have exploded in the 1990s! For example, in the preparation of drug candidates, the automated, permutational, and combinatorial use of chemical building blocks now allows the generation and screening of unprecedented numbers of compounds. Drug discovery - better, faster, cheaper? Indeed, more compounds have been made and screened in the 1990s than in the last hundred years of pharmaceutical research. This first volume covers: (i) combinatorial chemistry, (ii) combinatorial biology and evolution, and (iii) informatics and related topics. Within each section chapters are prepared by experts in the field, including, for example, in Section I: Coverage of mixture pools vs. parallel individual compound synthesis, solution vs. solid-phase synthesis, analytical tools, and automation. Section II highlights selection strategies and library-based evolution, phage display, peptide and nucleic acid libraries. Section III covers databases and library design, high through-put screening, coding strategies vs. deconvolutions, intellectual property issues, deals and collaborations, and successes to date.
Publisher: Springer Science & Business Media
ISBN: 9789072199232
Category : Medical
Languages : en
Pages : 376
Book Description
Combinatorial chemistry and molecular diversity approaches to scientific inquiry and novel product R&D have exploded in the 1990s! For example, in the preparation of drug candidates, the automated, permutational, and combinatorial use of chemical building blocks now allows the generation and screening of unprecedented numbers of compounds. Drug discovery - better, faster, cheaper? Indeed, more compounds have been made and screened in the 1990s than in the last hundred years of pharmaceutical research. This first volume covers: (i) combinatorial chemistry, (ii) combinatorial biology and evolution, and (iii) informatics and related topics. Within each section chapters are prepared by experts in the field, including, for example, in Section I: Coverage of mixture pools vs. parallel individual compound synthesis, solution vs. solid-phase synthesis, analytical tools, and automation. Section II highlights selection strategies and library-based evolution, phage display, peptide and nucleic acid libraries. Section III covers databases and library design, high through-put screening, coding strategies vs. deconvolutions, intellectual property issues, deals and collaborations, and successes to date.
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
Laboratory and Scientific Computing
Author: Joseph G. Liscouski
Publisher: Wiley-Interscience
ISBN:
Category : Science
Languages : en
Pages : 232
Book Description
Packed with timely and practical information on laboratory automation, this book surveys the current generation of lab computing technology, explores the diverse computing needs and opportunities in the modern lab, and outlines strategic considerations for selecting and implementing computer capabilities.
Publisher: Wiley-Interscience
ISBN:
Category : Science
Languages : en
Pages : 232
Book Description
Packed with timely and practical information on laboratory automation, this book surveys the current generation of lab computing technology, explores the diverse computing needs and opportunities in the modern lab, and outlines strategic considerations for selecting and implementing computer capabilities.
Scientific and Technical Aerospace Reports
Author:
Publisher:
ISBN:
Category : Aeronautics
Languages : en
Pages : 556
Book Description
Publisher:
ISBN:
Category : Aeronautics
Languages : en
Pages : 556
Book Description