
FDA Publishes Guidance on Drug-Drug Interaction Studies for a Therapeutic Protein
The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
FDA published
FDA states in the guidance that “when evaluating the potential for a DDI between a TP and small molecules or between TPs, sponsors should consider the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the TP as well as any co-administered medications in the patient population.” The document gives examples of situations where a DDI of a TP may be needed and recommends “a systematic, science-driven approach to evaluate the DDI potential of TPs.”
The guidance is a supplement to In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.
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