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Skin Delivery |
| Copyright © 2011 Joel L. Zatz |
Courses |
Dermatological Product Development |
Skin Product Development |
Introduction to Skin Product Development |
A 2-day course emphasizing theoretical principles and practical knowledge with wide applicability. It is designed for individuals engaged in research, development, and evaluation of prescription and OTC dermatological products. The intent of the course is to provide a basis for optimization with regard to physical properties of the product and biological activity. |
A 3-day course taught by experts in the field that provides fundamental concepts and practical information for the professional engaged in development and evaluation of skin care and OTC dermatological products. Various aspects of skin product development are considered from different points of view, as provided by the diverse backgrounds of the instructors. |
A 1-day course intended for individuals new to the area or those seeking to refresh their knowledge. This course contains elements of the full 3-day course. Topics include aspects of product quality, skin delivery and delivery systems, preservation and preservatives, regulatory considerations in product development, human safety & efficacy testing and a discussion of common disorders. Next offering: spring 2012 |
FDA SUPAC-SS guidance for industry provides recommended standards and requirements when scaling up and making changes to approved products. Also, useful information to have in mind during product development. Contains a description of the in vitro release test for semisolids.
FDA SUPAC-SS Manufacturing Equipment Addendum contains further information.
FDA Draft Guidance on Topical Ldocaine contains information relevant to approval of generic topical lidocaine products
Other FDA Guidances.
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