Dermal Drug Selection and Development

CHAPTER 1. INTRODUCTION 71.1. Developing a new medicine 1.2. Key risks at the candidate selection stage 1.3. Attrition in the pharmaceutical industry 1.4. Evolution of the Pharma R&D over the last 2 decades 1.5. Pharma R&D productivity in decline 1.6. Cost of Pharma R&D and cost up to Candidate selection 1.7. Increased risks to develop a topical drug 1.8. Increased opportunities to develop a topical drug CHAPTER 2. CHOOSING THE TOPICAL DRUG CANDIDATE : AN HISTORICAL OVERVIEW 192.1. The pragmatic topical drug development approach: An existing oral/systemic drug is further developed as a topical 2.2. Moving towards improved topical drug candidate selection processes: Use of in vivo models2.3. Historical topical drug candidate selection summary CHAPTER 3. KEY FACTORS AFFECTING THE EFFICACY OF A TOPICAL DRUG CANDIDATE: LEARNINGS FROM PAST TOPICAL DRUG DEVELOPMENT 313.1. Skin barrier condition vs. "Easiness" of topical drug development 3.2. Drug potency and clinical efficacy CHAPTER 4. TOPICAL VS ORAL/SYSTEMIC DRUG DISCOVERY 404.1. Drug Discovery Evolution 4.2. Oral/Systemic Drug Discovery 4.3. Topical Drug Discovery 4.4. The Two Key Differences in discharging risk in between the Oral/Systemic and Topical Drug Discovery Processes 4.5. Consequences for the Preclinical Stage: "Maximising the Percutaneous Flux" 4.6. What can be learned from the Oral Drug Development Process? CHAPTER 5. ASSESSING DRUG CONCENTRATION IN SKIN: DIRECT AND INDIRECT METHODS 525.1. Direct Methods 5.2. Indirect Methods 5.3. Potential Use of the various skin PharmacoKinetic Sampling Methods, Comparisons of the Methods and Consequences 5.4. Using the Percutaneous Flux or the Plasma concentration as surrogate measurement of skin concentration CHAPTER 6. ASSESSING TOPICAL EFFICACY 726.1. Assessing efficacy and dose prediction for a systemic target 6.2. In vivo PD Models: 6.3. Conclusion CHAPTER 7. ASSESSING THE THERAPEUTIC INDEX 867.1. Introduction 7.2. A "crude" Approach: Comparing the mass

Lionel Trottet, PhD is a DMPK Unit Manager, Drug Discovery chez Oncodesign in France. He has 20 years of expertise in Dermatology (dermal drug discovery, pharmacokinetics, PK/PD and formulation), 18 years of experience in general pharmacokinetics, drug metabolism and PK/PD, 13 years of experience as a DMPK representative in Drug Discovery projects, and 8 years of experience as a DMPK manager.
Howard Maibach, MD is an expert in contact and occupational dermatitis and sees patients at the Environmental Dermatosis Clinic, which is part of the Dermatology Clinic at University of California, San Francisco (UCSF). His specialty is dermatotoxicology, or skin exposure toxicity; allergies and skin disorders; and dermatopharmacology or the study of medications for skin disorders. Dr. Maibach has been on the editorial board of more than 30 scientific journals and is a member of 19 professional societies including the American Academy of Dermatology, San Francisco Dermatological Society and the Internal Commission on Occupation Health. He is a professor in the Department of Dermatology at UCSF.

"This book provides some valuable insights into the challenges related to the design and development of dermatopharmaceuticals. As such, this book is expected to be well received by the scientific community involved in this kind of research. ... this book should serve as a reference for anyone interested in developing dermatopharmaceuticals. ... Written by an expert in drug delivery, this book provides an overview of challenges the industry faces in selecting and developing a dermal product." (Rahmat M. Talukder, Doody's Book Reviews, September, 2017)