Pharmaceutical 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 quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Produk Detail:

  • Author : Walkiria S. Schlindwein
  • Publisher : John Wiley & Sons
  • Pages : 368 pages
  • ISBN : 1118895207
  • Rating : 3/5 from 1 reviews
CLICK HERE TO GET THIS BOOKPharmaceutical Quality by Design

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

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 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

Pharmaceutical Quality by Design Using JMP

Pharmaceutical Quality by Design Using JMP
  • Author : Rob Lievense
  • Publisher : Unknown Publisher
  • Release : 01 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

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

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 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

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

Computer Applications in Drug Discovery and Development

Computer Applications in Drug Discovery and Development
  • Author : Puratchikody, A.,Prabu, S. Lakshmana,Umamaheswari, A.
  • Publisher : IGI Global
  • Release : 23 November 2018
GET THIS BOOKComputer Applications in Drug Discovery and Development

With more restrictions upon animal experimentations, pharmaceutical industries are currently focusing on a new generation of experiments and technologies that are considerably more efficient and less controversial. The integration of computational and experimental strategies has led to the identification and development of promising compounds. Computer Applications in Drug Discovery and Development is a pivotal reference source that provides innovative research on the application of computers for discovering and designing new drugs in modern molecular biology and medicinal chemistry. While highlighting

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,

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
  • Author : Hamid Mollah,Mike Long,Harold Baseman
  • Publisher : John Wiley & Sons
  • Release : 18 March 2013
GET THIS BOOKRisk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release : 02 January 2020
GET THIS BOOKPharmaceutical Microbiological Quality Assurance and Control

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a