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The analysis of test article mixtures that are used in acute studies is problematic. Usually at the stage of product development, the analytical method is not fully developed. Also, getting the analytical department to schedule the analysis is difficult. Stability is not a problem since fresh solutions are used. In view of the fact that acute studies are not pivotal in gaining approval of a research or marketing permit, is it necessary to analyze test article mixtures?

812 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K December 26, 2020 0 Comments

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Blogolu28.38K Posted December 26, 2020 0 Comments

Yes. Although acute studies may be of lesser importance in assessing the safety of human
drugs, they are important for animal drugs, biological products and certain food additives.
For this reason, there must be some assurance that the test system was dosed with protocol
specified quantities of test article. The GLPs do not require that the analysis be done prior
to the use of the test article mixture provided that the mixture is stable on storage.

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