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Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of IberdomideNARA Subscribed
Iberdomide is a BCS III CELMoD™ agent currently under development for treatment of multiple myeloma. Five formulations were used during clinical development, starting with active ingredient in gelatin capsule (AIC), followed by subsequent formulations in gelatin (F1), HPMC capsules (F2 and F3), and finally the intended commercial form (ICF). A food effect study with the Phase I AIC formulation showed no food effect and two rel...
Idiopathic pulmonary fibrosis (IPF) is a progressive fatal interstitial lung disease that affects three million patients worldwide and currently without an effective cure. Zinpentraxin alfa, a recombinant human pentraxin-2 (rhPTX-2) protein, has been evaluated as a potential drug candidate for the treatment of IPF. Clinical pharmacokinetic analysis of zinpentraxin alfa has been challenging historically due to interference from...
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