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[Webinar Excerpt - 4:43 minutes] The Intent of ICH E14/S7B & Double Negative Nonclinical Scenarios Explained ICH E14/S7B streamlines QT assessment by harmonizing methodologies and allowing waivers, including a double-negative nonclinical scenario, reducing the need for costly clinical studies
Vries-dooi: Vermijd herhaalde vries-dooicycli van de gereconstitueerde oplossing
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Lunjani N, Satitsuksanoa P, Lukasik Z, Sokolowska M, Eiwegger T, OMahony L
