Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture - Image 1

£109.60

Wiley Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Name: Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Brand: Wiley
Price: 121.06 GBP
Availability: InStock

Pharmacy - Dispensing

Price History & Forecast

Last 85 days • 85 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 85 days • 3 price levels

Days at Price

Current Price

Price Analysis

Most common price: £121 (42 days, 49.4%)

Price range: £110 - £121

Price levels: 3 different prices over 85 days

Description

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 the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors―drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Product Specifications

Brand: Wiley
Format: hardcover
ASIN: 0470942371
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 23 March 2016
Listed Since: 02 August 2010

Barcode

No barcode data available

Wiley Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Pharmaceutical Quality by Design: A Practical Approach (Advances in Pharmaceutical Technology)

Pharmaceutical Quality by Design: Principles and Applications

Quality by Design for Biopharmaceuticals: Principles and Case Studies (Wiley Series in Biotechnology and Bioengineering)

Quality by Design for Biopharmaceutical Drug Product Development: 18 (AAPS Advances in the Pharmaceutical Sciences Series, 18)

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development: 10 (AAPS Introductions in the Pharmaceutical Sciences, 10)

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development: 10 (AAPS Introductions in the Pharmaceutical Sciences, 10)

Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design

How to Integrate Quality by Efficient Design (QbED) in Product Development (Expertise in Pharmaceutical Process Technology)

Quality by Design for Biopharmaceutical Drug Product Development: 18 (AAPS Advances in the Pharmaceutical Sciences Series, 18)

Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide

Wiley - Continuous Manufacturing of Pharmaceuticals Book

Springer - Introduction to Quality by Design (QbD) Book

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)

Butterworth-Heinemann Quality, Second Edition - Pharma Book

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: 129 (Drugs and the Pharmaceutical Sciences)

Wiley - Biological Drug Products: Development and Strategies

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems

The Future of Pharmaceutical Product Development and Research

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems (Expertise in Pharmaceutical Process Technology)

Chemical Engineering in the Pharmaceutical Industry: Active Pharmaceutical Ingredients

Wiley Analytical Testing for the Pharmaceutical GMP Laboratory