As a drug discovery project progresses from hit to lead and then to a drug candidate, preclinical toxicology studies uncover the toxic effects of a candidate molecule. Our in vivo preclinical non-GLP toxicity studies are designed to determine specific dose ranges, such as Median Lethal Dose 50% (LD50), Maximum Tolerated Dose (MTD), or No Observable Adverse Effect Level (NOAEL). The precise dose ranges are necessary for early-stage preclinical trials and evaluating the prospects of further development of the molecule. Bienta’s protocols follow 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 (BACUC). Our qualified research team will develop and implement the toxicity study protocol design to meet specific customer needs.
Our toxicology services:
- Toxicity class study
- Dose range-finding study (DRF)
- Toxicokinetics Studies in Rodents/pharmacodynamics in rodents
- Repeated dose toxicity study
- Acute toxicity study (LD50, MTD)
- Subacute/subchronic (repeated-dose) toxicity (MTD/NOAEL)
- Chronic toxicity study
- Acute Dermal Irritation/Corrosion Test
- In Vivo Eye Irritation Test
- Skin Sensitisation Test in Guinea Pig
- Genotoxicity assays
- Infusion toxicology
- PO, IV, IP, SC, IM, IN, with food.
- Observation for mortality, signs 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, paraffin- or cryogel-embedded tissues for histology, etc.