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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 then. Eventually, I cam...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150999/ https://www.ncbi.nlm.nih.gov/pubmed/32191998 http://dx.doi.org/10.3390/pharmaceutics12030273 |
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author | Miller, Kenneth |
author_facet | Miller, Kenneth |
author_sort | Miller, Kenneth |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-7150999 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-71509992020-04-20 Reconciling Quality by Design and Transdermal Product Development Miller, Kenneth Pharmaceutics Editorial 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. MDPI 2020-03-17 /pmc/articles/PMC7150999/ /pubmed/32191998 http://dx.doi.org/10.3390/pharmaceutics12030273 Text en © 2020 by the author. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Editorial Miller, Kenneth Reconciling Quality by Design and Transdermal Product Development |
title | 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_short | Reconciling Quality by Design and Transdermal Product Development |
title_sort | reconciling quality by design and transdermal product development |
topic | Editorial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150999/ https://www.ncbi.nlm.nih.gov/pubmed/32191998 http://dx.doi.org/10.3390/pharmaceutics12030273 |
work_keys_str_mv | AT millerkenneth reconcilingqualitybydesignandtransdermalproductdevelopment |