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Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 0080530354
Category : Science
Languages : en
Pages : 363
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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.
Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 0080530354
Category : Science
Languages : en
Pages : 363
Get Book Here
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.
Author: William Jeffrey Hurst
Publisher: John Wiley & Sons
ISBN: 9781560810254
Category : Science
Languages : en
Pages : 282
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Book Description
Author:
Publisher:
ISBN:
Category : Conference proceedings
Languages : en
Pages : 856
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Book Description
Author: S. Grabley
Publisher: Springer Science & Business Media
ISBN: 9783540648444
Category : Medical
Languages : en
Pages : 380
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Book Description
This book is unique in covering the present status and future potential of natural products in drug discovery. It provides readers with recent information regarding the impact on drug discovery, development and strategies, technical and automation aspects, and methods based on biochemistry as well as molecular biology, highlighting compounds from natural sources. Special emphasis is placed on the various strategies to gain access to natural compounds and combinatorial approaches by making use of both synthetic and biological methods.
Author: Georges Giralt
Publisher: Springer Science & Business Media
ISBN: 1447110218
Category : Technology & Engineering
Languages : en
Pages : 650
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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.
Author: David Allan Bradley
Publisher: CRC Press
ISBN: 9780748754434
Category : Technology & Engineering
Languages : en
Pages : 376
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Book Description
Mechatronics as a discipline has an ever growing impact on engineering and engineering education as a defining approach to the design, development, and operation of an increasingly wide range of engineering systems. The increasing scope and complexity of mechatronic systems means that their design and development now involve not only the technical aspects of its core disciplines, but also aspects of organization, training, and management. Mechatronics and the Design of Intelligent Machines and Systems reflects the significant areas of development in mechatronics and focuses on the higher-level approaches needed to support the design and implementation of mechatronic systems. Throughout the book, the authors emphasize the importance of systems integration. Each chapter deals with a particular aspect of the design and development process, from the specification of the system to software design and from the human-machine interface to the requirements for safe operation and effective manufacture. Notable among this text's many features is the use of a running case study-the autonomous and robotic excavator LUCIE-to illustrate points made in various chapters. This, combined with the authors' clear prose, systematic organization, and generous use of examples and illustrations provides students with a firm understanding of mechatronics as a discipline, some of the problems encountered in its various areas, and the developing techniques used to solve those problems.
Author: Junku Yuh
Publisher: Springer Science & Business Media
ISBN: 1461314194
Category : Computers
Languages : en
Pages : 251
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Book Description
All life came from sea but all robots were born on land. The vast majority of both industrial and mobile robots operate on land, since the technology to allow them to operate in and under the ocean has only become available in recent years. A number of complex issues due to the unstructured, hazardous undersea environment, makes it difficult to travel in the ocean while today's technologies allow humans to land on the moon and robots to travel to Mars . . Clearly, the obstacles to allowing robots to operate in a saline, aqueous, and pressurized environment are formidable. Mobile robots operating on land work under nearly constant atmospheric pressure; their legs (or wheels or tracks) can operate on a firm footing; their bearings are not subjected to moisture and corrosion; they can use simple visual sensing and be observed by their creators working in simple environments. In contrast, consider the environment where undersea robots must operate. The pressure they are subjected to can be enormous, thus requiring extremely rugged designs. The deep oceans range between 19,000 to 36,000 ft. At a mere 33-foot depth, the pressure will be twice the normal one atmosphere pressure of 29. 4 psi. The chemical environment of the sea is highly corrosive, thus requiring the use of special materials. Lubrication of moving parts in water is also difficult, and may require special sealed, waterproof joints.
Author: Mohammad Osman Tokhi
Publisher: World Scientific
ISBN: 9814525545
Category : Technology & Engineering
Languages : en
Pages : 884
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Book Description
The proceedings provide state-of-the-art scientific and engineering research findings and developments in the area of mobile robotics and assistive technologies. The proceedings collected together peer reviewed articles presented at the CLAWAR 2013 conference. It contains a strong showing of articles on legged locomotion with numbers of legs from two onwards. There is also a good collection of articles on systems that walls climbing, poles balancing, and other more complex structures following the traditional of CLAWAR themes. In addition, the proceedings also cover the subject of robot-human interaction, which focus on a more “human” way of communicating with humanoid robots. As for human assistive devices, proceedings also cover exoskeletal and prosthetic devices, robots for personal and nursing cares to address the issues of ageing population in our society. Finally, the issue of the deployment of robots in society, it social and ethically consideration are also addressed in the proceedings.
Author: Gianluca Antonelli
Publisher: Springer
ISBN: 3319778994
Category : Technology & Engineering
Languages : en
Pages : 374
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Book Description
A classic in underwater robotics. One of the first volumes in the “Springer Tracts in Advanced Robotics” series, it has been a bestseller through the previous three editions. Fifteen years after the publication of the first edition, the fourth edition comes to print. The book addresses the main control aspects in underwater manipulation tasks. With respect to the third edition, it has been revised, extended and some concepts better clustered. The mathematical model with significant impact on the control strategy is discussed. The problem of controlling a 6-degrees-of-freedoms autonomous underwater vehicle is investigated and a survey of fault detection/tolerant strategies for unmanned underwater vehicles is provided. Inverse kinematics, dynamic and interaction control for underwater vehicle-manipulator systems are then discussed. The code used to generate most of the numerical simulations is made available and briefly discussed.
Author: Judy A. Franklin
Publisher: Springer Science & Business Media
ISBN: 1461304717
Category : Computers
Languages : en
Pages : 218
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Book Description
Recent Advances in Robot Learning contains seven papers on robot learning written by leading researchers in the field. As the selection of papers illustrates, the field of robot learning is both active and diverse. A variety of machine learning methods, ranging from inductive logic programming to reinforcement learning, is being applied to many subproblems in robot perception and control, often with objectives as diverse as parameter calibration and concept formulation. While no unified robot learning framework has yet emerged to cover the variety of problems and approaches described in these papers and other publications, a clear set of shared issues underlies many robot learning problems. Machine learning, when applied to robotics, is situated: it is embedded into a real-world system that tightly integrates perception, decision making and execution. Since robot learning involves decision making, there is an inherent active learning issue. Robotic domains are usually complex, yet the expense of using actual robotic hardware often prohibits the collection of large amounts of training data. Most robotic systems are real-time systems. Decisions must be made within critical or practical time constraints. These characteristics present challenges and constraints to the learning system. Since these characteristics are shared by other important real-world application domains, robotics is a highly attractive area for research on machine learning. On the other hand, machine learning is also highly attractive to robotics. There is a great variety of open problems in robotics that defy a static, hand-coded solution. Recent Advances in Robot Learning is an edited volume of peer-reviewed original research comprising seven invited contributions by leading researchers. This research work has also been published as a special issue of Machine Learning (Volume 23, Numbers 2 and 3).
