Development and Validation of Analytical Methods

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.

Produk Detail:

  • Author : Christopher M. Riley
  • Publisher : Elsevier
  • Pages : 349 pages
  • ISBN : 9780080530352
  • Rating : 1/5 from 1 reviews
CLICK HERE TO GET THIS BOOKDevelopment and Validation of Analytical Methods

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods
  • Author : Christopher M. Riley,Thomas W. Rosanske
  • Publisher : Elsevier
  • Release : 29 May 1996
GET THIS BOOKDevelopment and Validation of Analytical Methods

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

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
  • Publisher : Elsevier
  • Release : 23 July 2020
GET THIS BOOKSpecification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life

ICH Quality Guidelines

ICH Quality Guidelines
  • Author : Andrew Teasdale,David Elder,Raymond W. Nims
  • Publisher : John Wiley & Sons
  • Release : 29 September 2017
GET THIS BOOKICH Quality Guidelines

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release : 01 August 2017
GET THIS BOOKPharmaceutical Analysis for Small Molecules

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis

Frontiers in Statistical Quality Control 8

Frontiers in Statistical Quality Control 8
  • Author : Hans-Joachim Lenz,Peter-Theodor Wilrich
  • Publisher : Physica
  • Release : 01 July 2022
GET THIS BOOKFrontiers in Statistical Quality Control 8

This volume treats the three main categories of Statistical Quality Control: General Aspects of SQC Methodology, On-line Control including Sampling Plans, Control Charts and Monitoring, and Off-line Control including Data Analysis, Calibration and Experimental Design. Experts with international reputation present their newest contributions.

Mutagenic Impurities

Mutagenic Impurities
  • Author : Andrew Teasdale
  • Publisher : John Wiley & Sons
  • Release : 02 March 2022
GET THIS BOOKMutagenic Impurities

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher : Academic Press
  • Release : 27 March 2019
GET THIS BOOKPharmaceutical Quality by Design

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici,Susan Bain
  • Publisher : Academic Press
  • Release : 13 June 2018
GET THIS BOOKAn Overview of FDA Regulated Products

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key

The International Pharmacopoeia

The International Pharmacopoeia
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 01 July 2022
GET THIS BOOKThe International Pharmacopoeia

A collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients and dosage forms intended to serve as source material for reference by any WHO member state.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
  • Publisher : National Academies Press
  • Release : 25 April 2020
GET THIS BOOKRegulating Medicines in a Globalized World

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators

International Pharmaceutical Product Registration, Second Edition

International Pharmaceutical Product Registration, Second Edition
  • Author : Anthony C. Cartwright,Brian R. Matthews
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKInternational Pharmaceutical Product Registration, Second Edition

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release : 16 December 2019
GET THIS BOOKHandbook of Pharmaceutical Manufacturing Formulations, Third Edition

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using