Pharmaceutical 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 testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Produk Detail:

  • Author : Sarwar Beg
  • Publisher : Academic Press
  • Pages : 448 pages
  • ISBN : 0128163720
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKPharmaceutical Quality by Design

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

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

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis
  • Publisher : John Wiley & Sons
  • Release : 09 October 2017
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is

Pharmaceutical Quality by Design Using JMP

Pharmaceutical Quality by Design Using JMP
  • Author : Rob Lievense
  • Publisher : SAS Institute
  • Release : 03 October 2018
GET THIS BOOKPharmaceutical Quality by Design Using JMP

Solve your pharmaceutical product development and manufacturing problems using JMP . Pharmaceutical Quality by Design Using JMP : Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand

Pharmaceutical Drug Product Development and Process Optimization

Pharmaceutical Drug Product Development and Process Optimization
  • Author : Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
  • Publisher : CRC Press
  • Release : 01 May 2020
GET THIS BOOKPharmaceutical Drug Product Development and Process Optimization

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher : Springer
  • Release : 01 April 2015
GET THIS BOOKQuality by Design for Biopharmaceutical Drug Product Development

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability

How to Integrate Quality by Efficient Design (QbED) in Product Development

How to Integrate Quality by Efficient Design (QbED) in Product Development
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release : 24 August 2019
GET THIS BOOKHow to Integrate Quality by Efficient Design (QbED) in Product Development

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for

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

Computer-aided applications in pharmaceutical technology

Computer-aided applications in pharmaceutical technology
  • Author : Jelena Djuris,Svetlana Ibric,Zorica Djuric
  • Publisher : Elsevier Inc. Chapters
  • Release : 10 April 2013
GET THIS BOOKComputer-aided applications in pharmaceutical technology

This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals
  • Author : Anurag S. Rathore,Rohin Mhatre
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKQuality by Design for Biopharmaceuticals

The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : Unknown Publisher
  • Release : 17 September 2021
GET THIS BOOKPharmaceutical Quality by Design

Includes several illustrative examples of applications, this book outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. --

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients
  • Author : David J. am Ende,Mary T. am Ende
  • Publisher : Wiley
  • Release : 23 April 2019
GET THIS BOOKChemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : Mary T. am Ende,David J. am Ende
  • Publisher : John Wiley & Sons
  • Release : 08 April 2019
GET THIS BOOKChemical Engineering in the Pharmaceutical Industry

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality