As a drug discovery project progresses from hit to lead and then to a drug candidate, preclinical toxicology studies are considered, in order to uncover toxic effects of a candidate molecule. Our in vivo preclinical non-GLP toxicological studies aim to establish dose range, provide preliminary identification of target organs, evaluate the level and duration of toxicity, and, in some cases, reveal delayed toxicity.
Our protocols are based on OECD Guidelines for the Testing of Chemicals #420, 423, 425, 407, and 408, and are reviewed and approved by Bienta’s Institutional Animal Care and Use Committee (IACUC). Our qualified research team will develop and implement study protocol design to meet any specific customer’s needs.
Acute toxicity: dose range studies (LD50, MTD, NOAEL);
Repeated dose toxicity studies;
Chronic and subchronic toxicity studies.
Available in-house animal species:
- Mice: Balb/cAnN, C57BL/6N, C57BL/6J, CD1(ICR), NMRI(Han);
- Rats: WI (Wistar), CD (SD);
- Other animals (hamsters, guinea pigs, gerbils) available on request.
- PO, IV, IP, SC, IM, IN, with food.
- Observation for mortality, sign of toxicity and behavioral changes on all required time points after administration;
- Weight measurement;
- Food intake measurement;
- Gross necropsy with macroscopic inspection;
- Toxicity blood panel: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, γ-Glutamyltransferase, Urea, Cholesterol, Creatinine, Creatine Kinase, Total Protein, Triglycerides, Lactate dehydrogenase;
- Hematological panel: Leucocytes (Monocytes, Basophiles, Eosinophils, Lymphocytes, Granulocytes), Erythrocytes, Thrombocytes, Hemoglobin, Hematocrit;
- Histopathology on demand.
We provide all requested biological samples from experimental animals, such as plasma samples, flash frozen tissues and paraffin- or cryogel-embedded tissues for histology, etc.