Efficacy and Mechanistic Models

Animal efficacy models became an important step in determining the fate of new drug candidates in a preclinical drug discovery pipeline.  Among all, mouse efficacy models are the most widely used  in biomedical research and preclinical drug evaluation.

At Bienta, we developed several efficacy models for your drug efficacy studies:

  • Mouse models of cancer;

  • Metabolic studies (Diabetes Type 1 and 2);

  • Studies of Aging;

  • Behavioral Models

 

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Toxicity Studies

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.

We offer:

  • Acute toxicity: dose range studies (LD50, MTD, NOAEL);

  • Toxicokinetics;

  • 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.

Administration routes:

  • PO, IV, IP, SC, IM, IN, with food.

We perform:

  • 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.

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Animal Studies

In order to continue expanding our services in preclinical toxicology and animal efficacy models, in 2016 Bienta launched the new Animal Research Facility for in vivo studies in rodents.

We claim that for animal studies Bienta is strictly following internationally accepted guidelines for ethical animal care (Bienta/Enamine Animal Work Statement).  All studies are approved by the Bienta’s Institutional Animal Care and Use Committee (IACUC). Protocol extracts are avaible upon sponsor’s requests.

Animal species:

  • Mice strains: Balb/cAnN, C57BL/6N, C57BL/6J, CD1(ICR), NMRI(Han), CDl-Foxnlnu; CB17.Cg-PrkdcscidLystbj-J
  • Rats: WI (Wistar), CD (SD)
  • Other animals (hamsters, rabbits, guinea pigs, gerbils) available on request

We offer:

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