Patient-focused Development of Biopharmaceutical Products

This open access book builds the case for the business motivation, techniques, and approaches to use in development of a medicinal product for human therapy, whether delivered via an oral dose form ("pill" or solution) or a delivery system (device). It shares the growing demands by patients and caregivers, as well as regulators, for designs which are most easily understood and usable, and which can ensure the medication can be consistently delivered and will, therefore, allow best outcomes. The book weaves skills in "human-centered design" into the design of medicinal delivery systems. It would be a reference for those in academia studying pharmacokinetics, formulation or product design and development, as well as those in the development of biopharmaceutical therapies.
This is an open access book.

List of contents

Preface.- Leveraging discovery research to inform product design.- The User's Eco-System.- User Needs in Drug Delivery - Unique Challenges with Combination Products.- Patient Focus in Drug Delivery Under Real World Constraints.- The Commercial Viewpoint.- Expectations from Regulators.- Diabetes Care Case Study.- Now what?.- Glossary.

Product details

• Assisted by: Wolfgang Fraunhofer (Editor), Robert R. Nesbitt (Editor), Ramakrishna Venugopalan (Editor)
• Publisher: Springer, Berlin
• Languages: English
• Product format: Hardback
• Release: 21.09.2025
• EAN: 9783031982521
• ISBN: 978-3-0-3198252-1
• No. of pages: 115
• Illustrations: III, 115 p. 32 illus., 29 illus. in color.
• Series: AAPS Advances in the Pharmaceutical Sciences Series
• Subjects: Natural sciences, medicine, IT, technology > Biology > Genetics, genetic engineering; Medizinische Chemie, Pharmazeutische Chemie, Pharmakologie, Technische Anwendung von Biomaterialien, Open Access, Quanten- und theoretische Chemie, Pharmacology, Pharmaceutics, Biomaterials-Vaccines, BIOLOGICS, drug delivery, Structure-Based Drug Design, patient-focused drug design, combination drug products, drug dose flexibility, FDA drug requirements