Safety/Adverse Effects

Safety/Adverse Effects

Through an extensive array of ex vivo human tissue assays, Biopta is able to provide invaluable human safety data for your compound early in the development cycle.

The benefits of undertaking safety testing in human tissues are many. When carried out in conjunction with the ICH S7A core battery, our data can provide an unparalleled indication of clinical safety and even reduce the number of animals required for in vivo experimentation. More importantly though, our data can help reduce the number of late stage failures as ‘go’ or ‘no go’ decisions can be made with confidence based on human responses. In addition to the positive effect on cost and time to clinic, human safety data adds significant value for investors and potential partners.

Routine safety assays conducted by Biopta include:

Condition Tissue Technique
Blood pressure Human subcutaneous resistance arteries Vessel diameter - myography
Arrhythmogenesis Human coronary artery Vessel diameter - myography
Diarrhoea or constipation

Human colon

Human gall bladder

Fluid transport - Ussing chamber

Gut motility - organ bath

Gall bladder contractility - organ bath

Cardiac contractility Human vetricular trabeculae Electrical field stimulation - organ bath

 

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