1st Edition
Dermal Drug Delivery From Innovation to Production
Chapter 1 Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements
Kenneth A Walters & Majella E Lane
Chapter 2 Preclinical and Clinical Safety and Assessment of Transdermal and Topical Dermatological Products
Lindsey C. Yeh & Howard I. Maibach
Chapter 3 Selection considerations for membranes and models for in-vitro/ex-vivo permeation studies
Pei-Chin Tsai, Tannaz Ramezanli, Dina Wadie, Sonia Trehan, Nathaly Martos, Zheng Zhang, Bozena Michniak-Kohn
Chapter 4 Design, Development, Manufacturing and Testing of Transdermal Drug Delivery Systems
Timothy A. Peterson, Steven M. Wick & Chan Ko
Chapter 5 Quality by Design (QbD) principles in the development of Transdermal Drug Delivery Products
Muralikrishnan Angamuthu, H.N. Shivakumar & S. Narasimha Murthy
Chapter 6 Microneedles for Drug Delivery: Industrial and Regulatory Perspectives
Lisa A. Dick, Dan M. Dohmeier, Ann M. Purrington & Scott A. Burton
Chapter 7 Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems
Tapash Ghosh
Chapter 8 Quality and Performance Tests for Dermal Drug Delivery Systems
Margareth R.C. Marques, Tony Bennett & Gregory Fieldson
Chapter 9 Perspective on Clinical Trials for Dermal Drug Delivery Systems
John T. Farrar & Shamir Kalaria
Chapter 10 Regulatory Standards for Approval of Topical Dermatological Drug Products
April C. Braddy & Dale P. Conner
Chapter 11 Gaps and Future Considerations for Development of Dermal Transdermal and Topical Delivery Systems
Caroline Stransinger
Chapter 12 Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems
Shulin Ding
Chapter 13 Development of Topical and Transdermal Dosage Forms: Regulatory Perspective
Amit Mitra & Sarah A. Ibrahim
Chapter 14 Innovations and Future Prospects of Dermal Delivery Systems
Rashmi Upasani, Anushree Herwadkar, Neha Singh and Ajay K. Banga
Biography
Tapash K. Ghosh is employed by the Office of Clinical Pharmacology and Biopharmaceutics at CDER, FDA. Before joining the FDA, he held faculty positions in the division of pharmaceutical sciences at the Massachusetts College of Pharmacy in Boston and Howard University in Washington, DC. He is the author of numerous scientific publications and the principle editor of other scientific books.
