Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective
Background: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a m...
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Formato: | Livro |
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Elsevier,
2017-02-01T00:00:00Z.
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A1234.567 |
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