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483 - In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?

Claims & Support/References for Claims

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Jennifer Carroll

wrote on last edited by

#1

Yes if by alignment you mean same population type, same endpoint, similar magnitude of effect as the data presented in the APS. Note that the data should be presented with the patient case rather than elsewhere. PAAB 3.1.1.
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