ADME Study

Drugs,studies,absorption,metabolite,dose,plasma,materials,phase,bioavailability,oral administrations,drug-related material,drug candidate,clinical studies,oral doses,samples,human metabolites,oral bioavailability,clearance,issues,systemic circulation.

Investigational drugs,mass balance studies,clinical pharmacology study,toxicology studies,preclinical studies,plasma concentrations,metabolites in plasma,fecal samples,Blood samples,type,human absorption,dosing,clinical phases,accelerator mass spectrometry.

Healthy volunteers,intravenous administrations,Food and Drug Administration,drug developers,drug development program,human mass balance study,study design,excretion studies,human plasma,major metabolite,absolute bioavailability,renal clearance,Regulatory requirements,preclinical species,digestive tract,Ethics Committee,U.S. Food and Drug Administration.

Unchanged drug,drug metabolism,study sponsor,observational studies,intravenous dose,plasma ratio,type of eligibility criteria,arm type,type of intervention model,Delay Results Type,oral absorption,radiolabeled material,FDA-defined phases,major issues,Advisory issues,United States,8-digit number,enterohepatic recirculation,primary completion,responsible party,birth defect,congenital anomaly,current hospital,Mass balance model,biliary excretion,behavioral interventions,drug applications,drug compound,proportion of drug escaping,hours post dose,dose level,radioactive dose,excreta samples,Feces samples,hours after dosing,oral dosing,renal blood clearance.