Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.

Practical drug development approaches presented by leadingexpertsDesigned to support the development of new, effectivetherapeutics, Topical and Transdermal Drug Delivery: Principlesand Practice explains the principles underlying the field andthen demonstrates how these principles are put into practice in thedesign and development of new drug products. Drawing together andreviewing the latest research findings, the book focuses onpractical, tested, and proven approaches that are backed byindustry case studies and the authors' firsthand experience.Moreover, the book emphasizes the mechanistic information that isessential for successful drug product development.Topical and Transdermal Drug Delivery: Principles andPractice is divided into two parts:* Part One, Current Science, Skin Permeation, andEnhancement Approaches, offers readers a fundamental understandingof the underlying science in the field. It describes the principlesand techniques needed to successfully perform experimentalapproaches, covering such issues as skin permeation, enhancementand assessment.* Part Two, Topical and Transdermal Product Developmentguides readers through the complete product development processfrom concept to approval, offering practical tips and cautions fromexperts in the field. This part also discusses regulations that arespecific to the development of dermal drug products. The finalchapter explores current and future trends, forecasting newdevelopment techniques and therapeutics.Throughout the book, the authors clearly set forth the basicscience and experimental procedures, making it possible forresearchers to design their own experimental approaches andaccurately interpret their results.With contributions from experienced drug researchers, this textis highly recommended for all researchers involved in topical andtransdermal product development who need to know both the state ofthe science and the standards of practice.

Preface ixAbout the Editors xiContributors xiiiPart One Current Science, Skin Permeation, and EnhancementApproaches1. Skin Structure, Function, and Permeation 3Heather A.E. Benson2. Passive Skin Permeation Enhancement 23Majella E. Lane, Paulo Santos, Adam C. Watkinson, and JonathanHadgraft3. Electrical and Physical Methods of Skin PenetrationEnhancement 43Jeffrey E. Grice, Tarl W. Prow, Mark A.F. Kendall, and MichaelS. Roberts4. Clinical Applications of Transdermal Iontophoresis 67Dhaval R. Kalaria, Sachin Dubey, and Yogeshvar N. Kalia5. In Vitro Skin Permeation Methodology 85Barrie Finnin, Kenneth A. Walters, and Thomas J. Franz6. Skin Permeation Assessment: Tape Stripping 109Sandra Wiedersberg and Sara Nicoli7. Skin Permeation Assessment: Microdialysis 131Rikke Holmgaard, Jesper B. Nielsen, and Eva Benfeldt8. Skin Permeation: Spectroscopic Methods 155Jonathan Hadgraft and Majella E. Lane9. Skin Permeation Assessment in Man: In Vitro-In VivoCorrelation 167Paul A. Lehman, Sam G. Raney, and Thomas J. Franz10. Risk Assessment 183Jon R. HeylingsPart Two Topical and Transdermal Product Development11. An Overview of Product Development from Concept to Approval203Adam C. Watkinson12. Regulatory Aspects of Drug Development for Dermal Products217William K. Sietsema13. Toxicological and Pre-clinical Considerations for NovelExcipients and New Chemical Entities 233Andrew Makin and Jens Thing Mortensen14. Topical Product Formulation Development 255Marc B. Brown, Robert Turner, and Sian T. Lim15. Transdermal Product Formulation Development 287Kenneth J. Miller16. Sensitivity and Irritation Testing 309Belum Viswanath Reddy, Geetanjali Sethi, and Howard I.Maibach17. New Product Development for Transdermal Drug Delivery:Understanding the Market Opportunity 345Hugh Alsop18. Transdermal and Topical Drug Delivery Today 357Adam C. Watkinson19. Current and Future Trends: Skin Diseases and Treatment367Simon G. Danby, Gordon W. Duff, and Michael J. CorkIndex 409