Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Produk Detail:

  • Author : Sarwar Beg
  • Publisher : Academic Press
  • Pages : 222 pages
  • ISBN : 0128203331
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKHandbook of Analytical Quality by Design

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release : 09 January 2021
GET THIS BOOKHandbook of Analytical Quality by Design

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : John Wiley & Sons
  • Release : 19 March 2018
GET THIS BOOKPharmaceutical Quality by Design

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that

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

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher : Academic Press
  • Release : 31 August 2018
GET THIS BOOKHandbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling,

Handbook of Analytical Validation

Handbook of Analytical Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher : CRC Press
  • Release : 24 April 2012
GET THIS BOOKHandbook of Analytical Validation

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher : Academic Press
  • Release : 11 November 2010
GET THIS BOOKHandbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation,

Handbook of Near-Infrared Analysis

Handbook of Near-Infrared Analysis
  • Author : Emil W. Ciurczak,Benoît Igne,Jerome Workman, Jr.,Donald A. Burns
  • Publisher : CRC Press
  • Release : 19 May 2021
GET THIS BOOKHandbook of Near-Infrared Analysis

Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control,

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition
  • Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
  • Publisher : CRC Press
  • Release : 28 October 2021
GET THIS BOOKHandbook of Validation in Pharmaceutical Processes, Fourth Edition

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
  • Publisher : John Wiley & Sons
  • Release : 01 September 2017
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by

Ewing's Analytical Instrumentation Handbook, Fourth Edition

Ewing's Analytical Instrumentation Handbook, Fourth Edition
  • Author : Nelu Grinberg,Sonia Rodriguez
  • Publisher : CRC Press
  • Release : 21 February 2019
GET THIS BOOKEwing's Analytical Instrumentation Handbook, Fourth Edition

This handbook is a guide for workers in analytical chemistry who need a starting place for information about a specific instrumental technique. It gives a basic introduction to the techniques and provides leading references on the theory and methodology for an instrumental technique. This edition thoroughly expands and updates the chapters to include concepts, applications, and key references from recent literature. It also contains a new chapter on process analytical technology.

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

Handbook of Statistical Analysis and Data Mining Applications

Handbook of Statistical Analysis and Data Mining Applications
  • Author : Robert Nisbet,Gary Miner,Ken Yale
  • Publisher : Elsevier
  • Release : 09 November 2017
GET THIS BOOKHandbook of Statistical Analysis and Data Mining Applications

Handbook of Statistical Analysis and Data Mining Applications, Second Edition, is a comprehensive professional reference book that guides business analysts, scientists, engineers and researchers, both academic and industrial, through all stages of data analysis, model building and implementation. The handbook helps users discern technical and business problems, understand the strengths and weaknesses of modern data mining algorithms and employ the right statistical methods for practical application. This book is an ideal reference for users who want to address massive and

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher : CRC Press
  • Release : 12 May 2021
GET THIS BOOKHandbook of Pharmaceutical Granulation Technology

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a

Handbook of Process Chromatography

Handbook of Process Chromatography
  • Author : Gunter Jagschies,Gail K. Sofer,Lars Hagel
  • Publisher : Elsevier
  • Release : 08 December 2007
GET THIS BOOKHandbook of Process Chromatography

This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of