cyprotex
the ADME Tox specialists

In Vitro Hemolysis Assay

Contact us for help assessing the toxic hemolysis potential of your drug formulations.

  • Drug-induced hemolysis is a relatively rare but serious toxicity liability. It occurs by two mechanisms1:
  • Toxic hemolysis − direct toxicity of the drug, its metabolite, or an excipient in the formulation.
  • Allergic hemolysis − toxicity caused by an immunological reaction in patients previously sensitized to a drug.
Cyprotex’s in vitro hemolysis testing is designed to screen for toxic hemolysis, as recommended by the US FDA.
  • Although the majority of normal individuals may suffer toxic hemolysis at sufficiently high concentrations of hemolytic drugs, for most drugs toxic hemolysis involves lower doses given to individuals who are genetically predisposed to hemolysis1.
  • The US FDA recommends that for excipients intended for injectable use, an in vitro hemolysis study should be performed at the intended concentration for IV administration to test for hemolytic potential2.
  • The in vitro hemolysis assay evaluates hemoglobin release in the plasma (as an indicator of red blood cell lysis) following test agent exposure.

Contact us to learn more about Cyprotex's hemolysis assays.

  in vitro hemolysis
 
‘For excipients intended for injectable use, an in vitro hemolysis study could be performed at the intended concentration for I.V. administration (bolus and/or infusion) to determine the hemolytic potential.’
FDA Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (May 2005)
Protocol +
Data +
Q&A +
References

1 Dausset J and Contu L (1967) Ann Rev Med 18; 55-70
2 FDA Guidance for Industry - Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (May 2005)

3 Lubran MM (1989) Ann Clin Lab Sci 19; 114-21
4 Deibler GE (1959) J Appl Physiol 14; 133-6

 
hemolysis

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This website was last updated
on 24th April 2014
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