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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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Detalles Bibliográficos
Autor principal: Miller, Kenneth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
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
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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.
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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
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