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Across the seven substances, committee members consistently returned to four questions: Is the bulk drug substance sufficiently identified and characterized

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[DOI] [PubMed] [Google Scholar] 148.Imbernon-Moya A., Ortiz-de Frutos F.J., Sanjuan-Alvarez M., Portero-Sanchez I., Merinero-Palomares R., Alcazar V