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In contrast, the passive diffusion process of B 12 absorption normally a very small portion of total absorption of the vitamin from food consumption may exceed the haptocorrin- and IF-mediated absorption when oral doses of B 12 are very large, with roughly 1% efficiency
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The FDAs biosimilar pathway, established under the BPCIA, requires extensive analytical characterization, animal studies, human pharmacokinetic and pharmacodynamic data, and in some cases clinical efficacy trials to demonstrate biosimilarity
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