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 toxicity studies are carried out to determine specific dose range, such as Median Lethal Dose 50% (LD50), Maximum Tolerated Dose (MTD), or No Observable Adverse Effect Level (NOAEL), which are necessary for early stage preclinical molecules to evaluate the perspectives of their further development. Bienta’s protocols are in accordance with 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 the toxicity study protocol design to meet any specific customer’s needs.
Bienta runs toxicity studies in four main stages:
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;
- Clinical Chemistry panel: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, γ-Glutamyltransferase, Urea, Cholesterol, Creatinine, Creatine Kinase, Total Protein, Triglycerides, Lactate dehydrogenase and other custom parameters;
- Hematological panel: Leukocytes (MID, Lymphocytes, Granulocytes), Erythrocytes, Platelets, Hemoglobin, Hematocrit.
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.