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Comprehensive Radiolabel Study Services

 Study preparation
Evaluation of the nonclinical ADME package
Dosimetry calculations
Study protocol design

 Radiolabel drug
Radiolabel drug synthesis through preferred partners 
Radiolabeled drug purity, radiopurity, and specific activity determination
Radiolabeled API purification or re-purification

Isotopic dilution, dosage formulation and stability evaluation

 Study conduct
√ Sample collection (blood, plasma, urine, and feces), processing and shipping
√ Provide training about handling radioactive samples for related sites

 Sample analysis
√ Excretion balance of total radioactive dose
√ Metabolite radioprofiling in plasma, urine and feces using state-
   of-the-art radiodetection  methods for low activity or volatile samples

PK analysis on total radioactivity, parent and metabolites and in blood
   and plasma

√ Metabolite characterization and identification

 

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