Quality by Design (QbD) for Topical Dermatological and Transdermal Product Development

Dear Colleagues,

The Quality by Design (QbD) approach can make the drug development and regulatory pathway more efficient, leading to the availability of high quality topical dermatological and transdermal products more quickly and reducing cost for the health care system and individual consumers. Implementation of the QbD approach involves the definition of the quality target product profile (QTPP) and critical quality attributes (CQAs) of a drug product, and the accomplishment of risk assessment to identify critical material attributes (CMAs) and critical process parameters (CPPs), the definition of a design space through design of experiments (DoEs), the establishment of a control strategy, and the continual improvement and innovation throughout the product life cycle. One of the critical areas of research is the definition of CQAs, the experimental models to evaluate those CQAs, and their application in the drug development process. This Special Issue is focused on the development and evaluation of CQAs for topical and transdermal products, ranging from simple semisolids and patches to nanotechnology formulations. Understanding the interrelationships between formulation components and CQAs, and their effect on efficacy and safety is critical to good topical or transdermal product design and performance.

Prof. Dr. Heather Benson
Dr. Yousuf Mohammed
Dr. Jeffrey E. Grice
Prof. Dr. Michael Roberts
Guest Editors

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