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Master Thesis

Les alternatives aux essais toxicologiques préclinique in vivo des médicaments à usage humain

Abstract : Toxicity testing is at a pivotal change thanks to technological advances in biology, biotechnology but also computer sciences. Since the first animal studies methods, the modeling of toxic effects in humans has now become multimedia: the animal remains an essential model, but others such as cell cultures or in silico models are becoming more and more important. Preclinical studies and their regulations are rapidly evolving. In addition, there is a growing political and social pressure to develop alternatives to animal models according to the principle of the 3Rs (reduction, refinement, and replacement of animal models). The objective is to improve the predictivity of the toxicity of a drug to ensure patient safety. For this, it is no longer the best model that is sought but the best combination of models, IATA (for Integrated Approaches to Testing and Assessment). These more flexible approaches to chemical safety assessment are based on the integration and translation of data derived from different methods and multiple sources. This approach is the one encouraged by regulators. The purpose of this document is to review the preclinical regulatory requirements for drug commercialization and the different possible approaches to achieve this.
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Master Thesis
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Submitted on : Monday, October 11, 2021 - 11:47:16 AM
Last modification on : Saturday, October 30, 2021 - 3:19:38 AM
Long-term archiving on: : Wednesday, January 12, 2022 - 7:29:01 PM


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  • HAL Id : dumas-03373026, version 1



Morgane Souchal. Les alternatives aux essais toxicologiques préclinique in vivo des médicaments à usage humain. Sciences du Vivant [q-bio]. 2021. ⟨dumas-03373026⟩



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