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Coagulation assay

Aim:

The aim of the assay is to detect the possible coagulation effect of the test item and its formulation buffer in human blood using a validated in vitro coagulation assay.

Test system:

In vitro test in human whole blood.

Design:

Control items (PBS and heparin), test item and vehicle are added to whole human blood samples and after several incubation times the PT (Prothrombin Time) and APTT (Activated Partial Thromboplastin Time) values are measured. The PT and APTT are the fundamental assays of the coagulation system. The PT and APTT are functional determination of the extrinsic and intrinsic pathway of coagulation, respectively. These values are utilized to detect the possible effect of drugs or excipients upon the process of extrinsic and/or intrinsic pathway.

Outcome:

For PT value:

  • Measured PT (sec)
  • PT normal (geometric mean value of laboratory for normal sample (normal value of control serum, sec)
  • RATA (PTsample/PTnormal)
  • INR (International Normalized Ratio, RATAISI, ISI = International Sensitivity Index)

For APTT value:

  • Measured APTT (sec)
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