Dermal Drug Delivery: From Innovation to Production - Couverture rigide

Couverture rigide

ISBN 10 : 1466582707 ISBN 13 : 9781466582705

Editeur : CRC Press Inc, 2019

Synopsis

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.

A propos du livre

À propos de l'auteur

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.

Détails de l'édition

• Éditeur: CRC Press Inc
• Date d'édition: 2019
• Langue: anglais
• ISBN 10: 1466582707
• ISBN 13: 9781466582705
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 447
• Éditeur: Ghosh Tapash K.
• Coordonnées du fabricant: non disponible
• Personne responsable: GPSR Kontakt; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne