Next Stage Live Testing Finally Underway – Canqura Product now in the research lab for testing.
Recently Croda has sent samples of our G3 patented product Qura100 to Cadila Pharmaceutical LTD in India who are going to undertake the live mouse testing for us. The product was shipped out to the laboratories of Cadila in India last week and has been safely received and the first round of tests will review the toxicity, dosage and residual effects tests and this will be followed by tests in live AML infected bodies for the very first time!
To remind oursleves of what is befor us, the objective of Qura-100 study is to assess the toxicological profile of the test item (MTD) alongwith PK/PD evaluation when treated to the test system as single dose. This study will provide information on dose response and the possible health hazards likely to arise from repeated exposure during short period of time. The Canqura product is considered an NCE which means New Clinical Entity. This means that all angles of its potential use must be tested and the ones we are about to undertake with Cadila will look at many things including side effects:
- Clinical signs - reactions to the dosages
- Pathology – changes or damage to various organs
- Histopathology – any changes in Biopsy of organs i.e. cell structure or appearance
- Cmax – looks at drug concentration at a time in blood
- AUC – Calculates total drug availability in blood during a particular time period
We expect and are hopeful of some progress to report in early September. Whilst this not the speedy time plan we had hoped for at the beginning of 2020, world circumstances combined with issues that Croda International had to resolve have dictated another time line but we are now back on track.
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