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Prescribers who consider off-label use in children under 12 face a complete absence of controlled trial data to guide dosing, safety monitoring, or expected outcomes

The presence of multiple amide and amine functionalities supports protonation under positive ion mode conditions

Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent to the bio-originator

Szentkiralyi, A., Fendrich, K., Hoffmann, W., Happe, S

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