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General Principles of Preclinical Study Design

Preclinical studies using animals to study the potential of a therapeutic drug or strategy are important steps before translation to clinical trials. However, evidence has shown that poor quality in the design and conduct of these studies has not only impeded clinical translation but also led to sig...

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Autores principales: Huang, Wenlong, du Sert, Nathalie Percie, Vollert, Jan, Rice, Andrew S. C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610693/
https://www.ncbi.nlm.nih.gov/pubmed/31707471
http://dx.doi.org/10.1007/164_2019_277
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author Huang, Wenlong
du Sert, Nathalie Percie
Vollert, Jan
Rice, Andrew S. C.
author_facet Huang, Wenlong
du Sert, Nathalie Percie
Vollert, Jan
Rice, Andrew S. C.
author_sort Huang, Wenlong
collection PubMed
description Preclinical studies using animals to study the potential of a therapeutic drug or strategy are important steps before translation to clinical trials. However, evidence has shown that poor quality in the design and conduct of these studies has not only impeded clinical translation but also led to significant waste of valuable research resources. It is clear that experimental biases are related to the poor quality seen with preclinical studies. In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources. We will also explore the differences between confirmatory and exploratory studies, and discuss available guidelines on preclinical studies and how to use them. This chapter, together with relevant information in other chapters in the handbook, provides a powerful tool to enhance scientific rigour for preclinical studies without restricting creativity.
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spelling pubmed-76106932021-04-27 General Principles of Preclinical Study Design Huang, Wenlong du Sert, Nathalie Percie Vollert, Jan Rice, Andrew S. C. Handb Exp Pharmacol Article Preclinical studies using animals to study the potential of a therapeutic drug or strategy are important steps before translation to clinical trials. However, evidence has shown that poor quality in the design and conduct of these studies has not only impeded clinical translation but also led to significant waste of valuable research resources. It is clear that experimental biases are related to the poor quality seen with preclinical studies. In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources. We will also explore the differences between confirmatory and exploratory studies, and discuss available guidelines on preclinical studies and how to use them. This chapter, together with relevant information in other chapters in the handbook, provides a powerful tool to enhance scientific rigour for preclinical studies without restricting creativity. 2020-01-01 /pmc/articles/PMC7610693/ /pubmed/31707471 http://dx.doi.org/10.1007/164_2019_277 Text en https://creativecommons.org/licenses/by/4.0/This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence and indicate if changes were made. The images or other third party material in this chapter are included in the chapter's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
spellingShingle Article
Huang, Wenlong
du Sert, Nathalie Percie
Vollert, Jan
Rice, Andrew S. C.
General Principles of Preclinical Study Design
title General Principles of Preclinical Study Design
title_full General Principles of Preclinical Study Design
title_fullStr General Principles of Preclinical Study Design
title_full_unstemmed General Principles of Preclinical Study Design
title_short General Principles of Preclinical Study Design
title_sort general principles of preclinical study design
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610693/
https://www.ncbi.nlm.nih.gov/pubmed/31707471
http://dx.doi.org/10.1007/164_2019_277
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