With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products.
This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products.
Key Features:
Presents current advancements including new technologies of transdermal and topical dosage forms.
Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.
Edited by:
Tapash K. Ghosh (The Food and Drug Administration Rockville Maryland USA)
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions:
Height: 234mm,
Width: 156mm,
Weight: 453g
ISBN: 9781032337418
ISBN 10: 1032337419
Pages: 464
Publication Date: 12 July 2022
Audience:
Professional and scholarly
,
Undergraduate
Format: Paperback
Publisher's Status: Active
Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements. Preclinical and Clinical Safety Assessment of Transdermal and Topical Dermatological Products. Selection Considerations for Membranes and Models for In Vitro/ Ex Vivo Permeation Studies. Design, Development, Manufacturing, and Testing of Transdermal Drug Delivery Systems. Quality by Design (QbD) Principles in the Development of Transdermal Drug Delivery Products. Microneedles for Drug Delivery: Industrial and Regulatory Perspectives. Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems. Quality and Performance Tests for Dermal Drug Delivery Systems. Perspective on Clinical Trials for Dermal Drug Delivery Systems. Regulatory Standards for Approval of Topical Dermatological Drug Products. Gaps and Future Considerations for Development of Transdermal and Topical Delivery Systems. Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems. Development of Topical and Transdermal Dosage Forms: Regulatory Perspective. Innovations and Future Prospects of Dermal Delivery Systems
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.
