Developing Drug Products in an Aging Society

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key aging markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Focuses on drug product development and prescribing for older patients from a multidisciplinary and global perspective Provides practical guidelines for developing drugs for this population Discusses regulatory pathways for medicines for older patients Includes supplementary material: sn.pub/extras

Autorentext
Sven Stegemann is the endowed professor for Patient-Centric Drug Product Design and Manufacturing at the Graz University of Technology and Director of Pharmaceutical Business Development at Capsugel. He is scientist, professor and advocate for multidisciplinary research on patient-centric drug products and affordable medicines. Prof. Stegemann trains the next generation of pharmaceutical scientists. His professional experience spans all stages of drug development and manufacturing--from early development through commercial manufacturing.His passion and research led him to found the Geriatric Medicine Society e.V. in 2009, a multidisciplinary network that aims to facilitate the development of age-appropriate medicines that older patients can easily and safely take. He also serves in various organizations as chairman or committee member to progress pharmaceutical sciences.He has established a focus group on patient-centric drug development through the American Association of Pharmaceutical Scientists (AAPS).As This is integral to improving the quality of life of patients in the future.He has spoken at innumerable conferences around the world on patient-centric drug delivery, pharmaceutical product development for special patient populations, multiparticulate technologies, adherence, geriatric drug delivery, quality by design and added value generics.

Inhalt
Healthcare provision in an aging society: US perspective.- Healthcare provision in an aging society: European perspective.- Healthcare provision in an aging society: Japanese perspective.- Old, Very Old, and Frail.- Age and the process of aging.- Comprehensive Geriatric Assessment.- Patients' clinical characteristics, disease, experience, and perception.- Ethical considerations in performing clinical trials in and for older people.- Patient reported outcomes from a clinical to a therapeutic tool.- Pharmacokinetic and Pharmacodynamic Considerations in the Elderly Population.- The Expectation of a Treatment Model: A framework for adherence and Effectiveness.- Pharmacoepidemiology and pharmacovigilance for safety and efficacy in older people.- Defining patient centric drug product design and its impact on improving safety and effectiveness.- Dosing considerations in older adults.- Oral Drug Product Use in the Elderly Patient Population.- Drug product development for older adults multiparticulate formulations.- Considerations for topical and transdermal drug delivery in older adults.- Injectable drug delivery for older patients.- Inhalation and Nasal Formulations.- Ophthalmic drug development and the elderly.- Developing drug administration devices for use by older patients.- Manufacturing Platforms for Patient-Centric Drug Products.- Novel Manufacturing Technologies for the Production of Patient-Centric Drug Products.- Prescribing to Older Adults.- Multimorbidity and Polypharmacy.- Vaccination in Older Adults.- Medication Reviews in Older Adults.- The Personalization of Drug therapy for Elderly patients.- Importance of Clinical Nutrition in Therapy to Older Adults.- Managing drug therapy of older patients in primary and secondary care.- Medication adherence and monitoring.- Medication compounding in the provision of drug therapy.- Geriatric Pharmacotherapy: Optimisation through integrated approach in the hospital setting.- European Medicines Agency (EMA): Regulatory perspectives on geriatric medicines.- Views on the Therapeutic Needs of Older Adults.- Future Perspectives in drug therapy of older people.- Opportunities in drug product development in an aging population.