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

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 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,

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,Phil W. Nethercote
  • Publisher : John Wiley & Sons
  • Release : 27 October 2014
GET THIS BOOKMethod Validation in Pharmaceutical Analysis

This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the

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

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

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,John H. McB. Miller
  • Publisher : John Wiley & Sons
  • Release : 06 March 2006
GET THIS BOOKMethod Validation in Pharmaceutical Analysis

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

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKHandbook of Pharmaceutical Granulation Technology

The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

Handbook of Food Process Modeling and Statistical Quality Control

Handbook of Food Process Modeling and Statistical Quality Control
  • Author : Mustafa Ozilgen
  • Publisher : CRC Press
  • Release : 01 March 2011
GET THIS BOOKHandbook of Food Process Modeling and Statistical Quality Control

Presenting mathematical prerequisites in summary tables, this book explains fundamental techniques of mathematical modeling processes essential to the food industry. The author focuses on providing an in-depth understanding of modeling techniques, rather than the finer mathematical points. Topics covered include modeling of transport phenomena, kin

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKHandbook of Pharmaceutical Granulation Technology

The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

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

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 Nanomaterials in Analytical Chemistry

Handbook of Nanomaterials in Analytical Chemistry
  • Author : Chaudhery Mustansar Hussain
  • Publisher : Elsevier
  • Release : 22 October 2019
GET THIS BOOKHandbook of Nanomaterials in Analytical Chemistry

Handbook of Nanomaterials in Analytical Chemistry: Modern Trends in Analysis explores the recent advancements in a variety of analytical chemistry techniques due to nanotechnology. It also devotes several chapters to the analytical techniques that have proven useful for the analysis of nanomaterials. As conventional analytical chemistry methods become insufficient in terms of accuracy, selectivity, sensitivity, reproducibility, and speed, recent advances have opened up new horizons for chemical analysis and detection methods. Chapters are authored by experts in their respective fields

Swainson’s Handbook of Technical and Quality Management for the Food Manufacturing Sector

Swainson’s Handbook of Technical and Quality Management for the Food Manufacturing Sector
  • Author : M Swainson
  • Publisher : Woodhead Publishing
  • Release : 15 November 2018
GET THIS BOOKSwainson’s Handbook of Technical and Quality Management for the Food Manufacturing Sector

This book is focused on the expansive and highly demanding subject of Food Industry "Technical & Quality Management". As the world’s most vital industry "Food Production" is complex, multifaceted and continuously scrutinised. Food scares and product recalls, on national and international scales, demonstrate the persistent challenge to identify, monitor and control all hazards, and also address the increasing criminal threats of Food Fraud, Adulteration & Intentional Contamination. With the benefit of unique perspectives gained by working across Quality, Technical and Operations