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.
Автор: Mario Vanhoucke Название: Integrated Project Management Sourcebook ISBN: 3319801244 ISBN-13(EAN): 9783319801247 Издательство: Springer Рейтинг: Цена: 27950.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This handbook is a unique,comprehensive resource for professional project managers and students inproject management courses that focuses on the integration between baselinescheduling, schedule risk analysis and project control, also known as DynamicScheduling or Integrated Project Management and Control.
Описание: Advance in your product management career and create innovative products that customers love! Regardless of industry or sector, to compete in today's business world, product managers must understand how their customer's preferences change, how technology evolves, and how to anticipate what competitors might do. You need a reliable resource that provides timely guidance and practical tools to help you compete. With new content and expert advice, this updated edition of The Product Manager's Survival Guide brings you fully up to date on what you need to succeed as a product manager. For your professional future, you'll learn it's not the development technique that will help you get ahead, it's how you think like a strategically minded business person. Your continuous learning starts with your product management acumen assessment, and takes root, when you develop your own professional development strategy. As you continue your career journey, you'll be able to become a member of the exclusive product management professional community (for readers of this book) at www.sequentlearning.com/community. The Product Manager's Survival Guide, Second Edition features brand new material, including: - A product management acumen assessment (https: //survey.sequentlearning.com/s3/PMAcumen) - Action planning ideas at the end of each chapter - Techniques to earn empowerment - Tools to develop product strategies and roadmaps - Methods to deploy and release products - Metrics to assess product performance Simple and easy to understand, this invaluable guide will help you bring your company into the digital age and continue to evolve with changing times.
