Developing Drug Products in an Aging Society

1. Front Matter

   Pages i-xviii

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2. Introduction

   1. Front Matter

      Pages 1-1

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   2. Healthcare Provisions in an Aging Society: U.S. Perspective

      • Ajoy C. Karikkineth

      Pages 3-21

   3. Healthcare Provision in an Aging Society—The European Perspective

      • Peter Crome, Joanna Pleming

      Pages 23-44

   4. Healthcare Provisions in the Aging Society: Japanese Perspectives

      • Naoko Muramatsu

      Pages 45-57

3. The Patient(s)

   1. Front Matter

      Pages 59-59

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   2. Old, Very Old and Frail

      • Jean-Pierre Baeyens

      Pages 61-66

   3. Age and the Process of Aging

      • Paul A. F. Jansen

      Pages 67-86

   4. Comprehensive Geriatric Assessment

      • Jacob Blumenthal, Steven R. Gambert

      Pages 87-101

   5. Patients’ Clinical Characteristics, Disease Experience, and Perception

      • Sven Stegemann

      Pages 103-113

4. Clinical Development of Drug Products for Older Adults

   1. Front Matter

      Pages 115-115

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   2. Ethical Considerations in Performing Clinical Trials in and for Older People

      • Florian von Raison and Laurence Hugonot-Diener on behalf of the Geriatric Medicine Working Party (GMWP), European Forum of Good Clinical Practice (EFGCP)

      Pages 117-128

   3. Patient Reported Outcomes in Clinical Trials and Practice with Older Patients

      • Sven Stegemann

      Pages 129-138

   4. Pharmacokinetic and Pharmacodynamic Considerations in Elderly Population

      • Jatinder Kaur Mukker, Ravi Shankar Prasad Singh, Hartmut Derendorf

      Pages 139-151

   5. The Expectation to Treatment Model: A Framework for Adherence and Effectiveness

      • Sven Stegemann

      Pages 153-170

   6. Pharmacoepidemiology and Pharmacovigilance for Safety and Efficacy in Older People

      • Sarah N. Hilmer, Danijela Gnjidic

      Pages 171-188

5. Product Development for Older Adults

   1. Front Matter

      Pages 189-189

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   2. Defining Patient Centric Drug Product Design and Its Impact on Improving Safety and Effectiveness

      • Sven Stegemann

      Pages 191-216

   3. Dosing Considerations in Older Adults

      • Gregory J. Hughes, Judith L. Beizer

      Pages 217-224

   4. Oral Drug Product Use in the Elderly Patient Population

      • Robert L. Ternik

      Pages 225-246

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.

• adherence
• aging
• drug development
• regulations
• geriatric
• drug dosage
• multimorbidity
• polypills
• healthcare

“This book reviews a wide range of topics related to drug development for an aging population … . The intended audience includes practitioners and/or researchers interested in sharing multidisciplinary knowledge, research, and practice expertise to fill existing knowledge gaps in order to improve drug product development for older, very old, multimorbid, and frail individuals.” (Susan K. Romann, Doody's Book Reviews, February, 2017)

• Graz University of Technology, Graz, Austria

  Sven Stegemann

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.

Policies and ethics