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 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 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 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,

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 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

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

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.

Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology

Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology
  • Author : James A. Kent
  • Publisher : Springer Science & Business Media
  • Release : 27 May 2010
GET THIS BOOKKent and Riegel's Handbook of Industrial Chemistry and Biotechnology

This substantially revised and updated classic reference offers a valuable overview and myriad details on current chemical processes, products, and practices. No other source offers as much data on the chemistry, engineering, economics, and infrastructure of the industry. The two volume Handbook serves a spectrum of individuals, from those who are directly involved in the chemical industry to others in related industries and activities. Industrial processes and products can be much enhanced through observing the tenets and applying the methodologies

Handbook of Industrial Chemistry and Biotechnology

Handbook of Industrial Chemistry and Biotechnology
  • Author : James A. Kent
  • Publisher : Springer Science & Business Media
  • Release : 13 January 2013
GET THIS BOOKHandbook of Industrial Chemistry and Biotechnology

Substantially revising and updating the classic reference in the field, this handbook offers a valuable overview and myriad details on current chemical processes, products, and practices. No other source offers as much data on the chemistry, engineering, economics, and infrastructure of the industry. The Handbook serves a spectrum of individuals, from those who are directly involved in the chemical industry to others in related industries and activities. It provides not only the underlying science and technology for important industry sectors,

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
  • Author : Safaraz K. Niazi
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKHandbook of Pharmaceutical Manufacturing Formulations

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Handbook of Radioactivity Analysis

Handbook of Radioactivity Analysis
  • Author : Michael F. L'Annunziata
  • Publisher : Academic Press
  • Release : 07 March 2020
GET THIS BOOKHandbook of Radioactivity Analysis

Handbook of Radioactivity Analysis: Radiation Physics and Detectors, Volume One, and Radioanalytical Applications, Volume Two, Fourth Edition, constitute an authoritative reference on the principles, practical techniques and procedures for the accurate measurement of radioactivity - everything from the very low levels encountered in the environment, to higher levels measured in radioisotope research, clinical laboratories, biological sciences, radionuclide standardization, nuclear medicine, nuclear power, and fuel cycle facilities, and in the implementation of nuclear forensic analysis and nuclear safeguards. It includes sample

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