Method Validation in Pharmaceutical Analysis PDF Download
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Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
Get Book Here
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: James O. Westgard
Publisher: AACC Press
ISBN: 9781886958197
Category : Business & Economics
Languages : en
Pages : 292
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Book Description
With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.
Author: James O. Westgard
Publisher:
ISBN: 9781886958333
Category :
Languages : en
Pages : 308
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Book Description
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: Mark Stauffer
Publisher: BoD – Books on Demand
ISBN: 1789230845
Category : Science
Languages : en
Pages : 176
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Book Description
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.
Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 047146371X
Category : Science
Languages : en
Pages : 320
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Book Description
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Author: Gale Miller
Publisher: SAGE
ISBN: 9781446225059
Category : Social Science
Languages : en
Pages : 242
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Book Description
A critical examination of the principles and practice of qualitative research is provided in this book which examines the interplay between context and method, making it invaluable for both the experienced and the beginning researcher. A range of methodological and practical issues central to the concerns of qualitative researchers are addressed. These include: the validity and plausibility of qualitative methods; the problems encountered using specific techniques in a range of social settings; and the moral issues raised in qualitative research. These themes are related to practical issues which are illustrated by a breadth of examples and in-depth case studies. The contributors look at the methods and strategies that they have used to study everyday life, and make suggestions to readers on why and how they might conduct their own studies. They raise issues that go beyond `cookbook' discussions of issues such as how to enter social settings, manage the subjects of one's research and ask `good' questions in the process of formulating research strategies. These issues are addressed within the framework of the larger purposes and uses of qualitative research where specific methodological problems are not used as ends in themselves.
Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 1482229773
Category : Science
Languages : en
Pages : 95
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Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Author: Dimiter M. Dimitrov
Publisher: John Wiley & Sons
ISBN: 1119019281
Category : Psychology
Languages : en
Pages : 352
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Book Description
“Dr. Dimitrov has constructed a masterpiece—a classic resource that should adorn the shelf of every counseling researcher and graduate student serious about the construction and validation of high quality research instruments. —Bradley T. Erford, PhD Loyola University Maryland Past President, American Counseling Association “This book offers a comprehensive treatment of the statistical models and methods needed to properly examine the psychometric properties of assessment scale data. It is certain to become a definitive reference for both novice and experienced researchers alike.” —George A. Marcoulides, PhD University of California, Riverside This instructive book presents statistical methods and procedures for the validation of assessment scale data used in counseling, psychology, education, and related fields. In Part I, measurement scales, reliability, and the unified construct-based model of validity are discussed, along with key steps in instrument development. Part II describes factor analyses in construct validation, including exploratory factor analysis, confirmatory factor analysis, and models of multitrait-multimethod data analysis. Traditional and Rasch-based analyses of binary and rating scales are examined in Part III. Dr. Dimitrov offers students, researchers, and clinicians step-by-step guidance on contemporary methodological principles, statistical methods, and psychometric procedures that are useful in the development or validation of assessment scale data. Numerous examples, tables, and figures provided throughout the text illustrate the underlying principles of measurement in a clear and concise manner for practical application. *Requests for digital versions from ACA can be found on www.wiley.com. *To purchase print copies, please visit the ACA website here. *Reproduction requests for material from books published by ACA should be directed to
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Author: Kemper E. Lewis
Publisher: American Society of Mechanical Engineers
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 360
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Book Description
Whether you are an engineer facing decisions in product design, an instructor or student engaged in course work, or a researcher exploring new options and opportunities, you can turn to Decision Making in Engineering Design for: Foundations and fundamentals of making decisions in product design; Clear examples of effective application of Decision-Based Design; State-of-the-art theory and practice in Decision-Based Design; Thoughtful insights on validation, uncertainty, preferences, distributed design, demand modeling, and other issues; End-of-chapter exercise problems to facilitate learning. With this advanced text, you become current with research results on DBD developed since the inception of The Open Workshop on Decision-Based Design, a project funded by the National Science Foundation.
