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Open AccessEditorial

Reconciling Quality by Design and Transdermal Product Development

ISYN Consulting LLC, Melrose, FL 32666, USA
Pharmaceutics 2020, 12(3), 273; https://doi.org/10.3390/pharmaceutics12030273
Received: 17 February 2020 / Accepted: 5 March 2020 / Published: 17 March 2020
Since my first exposure to the acronym ‘QbD’ more than ten years ago, I have been trying to understand exactly what QbD is and how I might incorporate its teachings into my twenty-odd years of experience developing transdermal systems. I feel I have made little progress since then. Eventually, I came to realize that while QbD has its merits, it is not a guide for (transdermal) product development, despite so often being described as such. Instead, I have come to consider QbD as a language useful for organizing and presenting the array of data supporting the approval of a new product, but it still leaves the experimental approach entirely up to the developer. What QbD does provide to the development community is a means of conveying product information through a consistent framework facilitating both internal and regulatory review. As a result, new ‘QbD’ product applications tend to be more uniform and complete than the applications that preceded the initiative. View Full-Text
Keywords: quality by design; transdermal product development quality by design; transdermal product development
MDPI and ACS Style

Miller, K., II. Reconciling Quality by Design and Transdermal Product Development. Pharmaceutics 2020, 12, 273.

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