Stable Isotope Tracer Methodologies

Stable Isotope Metabolic Assessments

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Case study – Dual tracer study

A mid-cap pharmaceutical company sought out ProSciento to manage all aspects of a complicated dual tracer phase 1 diabetes study.

patient and doctor in the ProSciento Clinical Research Unit

With a short timeline, and a limited budget, ProSciento ordered the raw tracer material: [1-13C] sodium acetate, and [6,6-2H2] glucose, and successfully completed the following:

  • Managed seven vendors: three specialty suppliers, three specialty tabs, and one contract manufacturing organization
  • Helped to manage the manufacturing proposal, the batch record, quality assurance/quality control, certificate of analysis, etc. as there was no commercial tracer solution available
  • Compounded the tracers separately in ProSciento’s USP 797 clean room using a 28-step sterile procedure
  • Used cold chain shipment logistics for tracer drug sample collection
  • Developed an assay to analyze the samples
  • Created a detailed drug manual
  • Submitted a final report and managed tracer material destruction

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