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 many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

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

Product design is a comprehensive process related to the creation of new products, and the ability to design and develop efficient products are key to success in today’s dynamic global market. Written by experts in the field, this book provides a comprehensive overview of the product design process and its applications in various fields, particularly engineering. Over seven chapters, the authors explore such topics as development of new product design methodologies, implementation of effective methods for integrated products, development of more visualized environments for task-based conceptual design methods, and development of engineering design tools based on 3D photogrammetry, among others.

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

The second edition of a bestseller, this book discusses an integrated product and process design that has been successfully used to conceptualize, design, and rapidly product competitively-priced quality products. It examines the overlapping, interacting, and iterative nature of the engineering aspects that impact the product realization process. A detailed introduction to the creation of high quality products, the new edition explores the role of innovation, requirements engineering, smart materials, different rapid prototyping methods, and life-cycle cost determination, to name just a few. The book delineates proven methods that have been used successfully to create products.

Based on methods of actual product developments from Goodyear Aerospace and Hewlett-Packard, this engrossing book provides specific guidelines plus a wealth of data for rapid and efficient development of new products using a systems theory which works vertically through an industry's management structure and horizontally across functions that contribute to new product development. Demonstrates how to integrate the best available tools with appropriate techniques and how to deliver new products within performance objectives and budget. An abundance of checklists, data and reference material enable readers to implement the methods presented.