Reconciling Quality by Design and Transdermal Product Development
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 the...
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doaj-2bf80b2074e34256861f9a8e9232617f2020-11-25T03:12:36ZengMDPI AGPharmaceutics1999-49232020-03-0112327310.3390/pharmaceutics12030273pharmaceutics12030273Reconciling Quality by Design and Transdermal Product DevelopmentKenneth Miller0ISYN Consulting LLC, Melrose, FL 32666, USASince 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.https://www.mdpi.com/1999-4923/12/3/273quality by designtransdermal product development |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kenneth Miller |
spellingShingle |
Kenneth Miller Reconciling Quality by Design and Transdermal Product Development Pharmaceutics quality by design transdermal product development |
author_facet |
Kenneth Miller |
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Kenneth Miller |
title |
Reconciling Quality by Design and Transdermal Product Development |
title_short |
Reconciling Quality by Design and Transdermal Product Development |
title_full |
Reconciling Quality by Design and Transdermal Product Development |
title_fullStr |
Reconciling Quality by Design and Transdermal Product Development |
title_full_unstemmed |
Reconciling Quality by Design and Transdermal Product Development |
title_sort |
reconciling quality by design and transdermal product development |
publisher |
MDPI AG |
series |
Pharmaceutics |
issn |
1999-4923 |
publishDate |
2020-03-01 |
description |
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. |
topic |
quality by design transdermal product development |
url |
https://www.mdpi.com/1999-4923/12/3/273 |
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