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Pharmaceutics Article In Vitamin Silicon Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets Deanna M. Mudie *, Aaron M. Stewart and David T. Vodka, Jesus A. Rosales
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In vitro-in silico tools refer to the combination of experimental methods conducted in a controlled environment outside of a living organism (in vitro) with computer-based models and simulations (in silico) to predict the behavior of biological systems.
Companies or organizations involved in the development, testing, or use of pharmaceuticals, chemicals, or other products that may have an impact on human health or the environment are required to file in vitro-in silico tools.
In vitro-in silico tools can be filled out electronically on the designated platform provided by the regulatory authority. The form typically requires information on the specific test methods, results, and any supporting data or models used.
The purpose of in vitro-in silico tools is to provide a more cost-effective, efficient, and ethical approach to predict the potential toxicity or efficacy of substances without the need for traditional animal testing.
Information that must be reported on in vitro-in silico tools includes the test methods used, the results obtained, any supporting data or models, and any conclusions drawn from the analysis.
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