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Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluationNARA Subscribed
Purpose A series of iterative population pharmacokinetic (PK) modeling and probability of target attainment (PTA) analyses based on emerging data supported dose selection for aztreonam-avibactam, an investigational combination antibiotic for serious Gram-negative bacterial infections. Methods Two iterations of PK models built from avibactam data in infected patients and aztreonam data in healthy subjects with “patient-like” as...
Volumetric absorptive microsampling (VAMS) techniques have gained popularity these last years as innovative tool for collection of blood pharmacokinetic (PK) samples in clinical trials as they offer many advantages over dried blood spot and conventional venous blood sampling. The use of Mitra ® , a blood collection device based on volumetric absorptive microsampling (VAMS) technology, was implemented during clinical developmen...
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