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Example 2 Your firm failed to test Active Pharmaceutical Ingredients (API) prior to use in manufacturing drug products

10.1016/j.ejphar.2006.01.037 Eur

The BDNF evidence includes preclinical studies showing a 1.4-fold increase in hippocampal BDNF protein and a 3-fold increase in BDNF mRNA expression following a single dose, and a human stroke trial in 110 patients where intranasal Semax produced measurable plasma BDNF elevation associated with improved motor function recovery

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