Mass balance study

• Check total C14 marker drug recovery following administration
• Target Animals: Rat, Mouse, Dog
• Analysis: LSC, AMS

Metabolite profiling/identification study (microtracing study)

• Identify metabolites in plasma, urine, and feces following the defined dose administration of drug (including trace amount of C14 marker drug)
• Target Animals: Rat, Mouse, Dog
• In vitro: (Human, rat, mouse, dog) hepatocyte, microsomes
• Analysis: LC-QTOF, AMS, LC-MS/MS, NMR

Non-clinical pharmacokinetic analysis of other RI markers

• Biodistribution Study: Check the amount of marker substance in tissue following the injection of RI marker drug into a living body I125 Marker - Can assess the in vivo distribution of biopharmaceuticals including antibody drug
• QWBA: Check the distribution of and quantify the RI marker compound in animal
• Pathological Analysis of Blood and Tissue: Conduct biochemical/blood analysis, pathological analysis on each tissue

C14 clinical pharmacokinetic analysis

Phase 0 PK study

• Analyze the blood concentration of C14 marker drug using AMS following microdosing
• Conduct first-in-human pharmacokinetic analysis and absolute BA analysis

Microtracing study

• Support and analyze metabolite identification/validation in plasma, urine, and feces following the defined dose administration of drug (including trace amount of C14 marker drug)
• Analysis: LC-QTOF, AMS, LC-MS/MS, NMR