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For instance, administering IGF-1R mAbs in cancer trials was reported to result in increased adverse events in younger populations 34 , including insulin resistance, possibly due in part to disruption of the somatotropic axis and associated deleterious effects of excess GH 41,42

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Considerations of Excipient-Transporter Interaction M9 guidance requires a BCS-based biowaiver proposal to include a mechanistic and risk-based approach in assessing if differences between test and reference product (e.g

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