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

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.

General

Imprint:	Academic Press Inc
Country of origin:	United States
Series:	Expertise in Pharmaceutical Process Technology
Release date:	August 2019
First published:	2020
Authors:	Bhavishya Mittal
Dimensions:	229 x 152mm (L x W)
Format:	Paperback
Pages:	274
ISBN-13:	978-0-12-816813-4
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Business & Economics > Business & management > Management of specific areas > Production & quality control management Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries Books > Medicine > Other branches of medicine > Pharmacology > General Promotions
LSN:	0-12-816813-7
Barcode:	9780128168134

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