Project Description

California FDA GMP Toxicology Laboratory needed for small molecule toxicity testing which will hopefully go to clinical study.

The non-clinical laboratory study is hopefully conducted in conformance with the U.S. Food and Drug Administration Good Laboratory Practice regulations, 21 CFR part 58.

Here is one toxicity study some lab did for us before. 24 rats of each sex (12/sex/group, 6/sex/sacrifice timepoint) were assigned to a dose group and a vehicle control group and administered new drug intravenously via the tail vein at 0 (vehicle only) and 400 ug/kg/day as a single dose on Study Day 0. Groups of 5 animals/sex were sacrificed on Study day 1 (24 hours) and 14 for evaluation of clinical pathology and organ toxicity.

The animals were monitored prior to the administration of the test article new drug and up to 14 days following the administration of the test article. Parameters monitored included comprehensive blood chemistry and hematology, body weight and temperature, food and water consumption, histopathology and daily clinical observation.

At last, we need a detailed and reproducible report on the survival (morbidity and mortality), body weights, food and water consumption, clinical pathology (hematology and clinical chemistry), pathology, gross pathology, organ weights, and histopathology.

Here is just a rough idea about what we want. This is not necessarily exactly what it should be. I'd like to talk details with you or your colleagues.

If ok, I need to have a quota for the test. By the way, Call me or email when you have some updates regarding to this.

Thanks,