Menu
During the preclinical stage of drug development, CEBIS USA offers a wide range of services in method development, validation, impurity profiling, impurity isolation, characterization, certification, and evaluation, as well as services in genetic and mammalian toxicology, drug metabolism, pharmacokinetics, and bio-analysis.
A variety of preclinical investigations using rodents and non-rodents are made possible by the toxicology expertise at VBS. These studies include single dosage, MTD, 4, 13, 26, and 52-week studies, and they are carried out in accordance with international regulatory standards, including ICH, EMA, and relevant standards for the European and US FDA.
Repeat exposure studies in rodents and non-rodents: Acute Toxicity, Local Lymph Node Assay (LLNA), Skin Sensitization (in vitro and in vivo), Sub-acute (1, 2 and 4 week exposures), Sub-chronic (13 weeks), and Chronic Toxicity (26-52 weeks), Carcinogenicity and combined carcinogenicity (104 weeks in rats and 78 weeks in mice).
Toxicology of Development and Reproduction: pre- and post-natal developmental toxicity single- and multigenerational reproductive toxicity, fertility and early embryonic development, embryo fetal development.
Our hardworking scientific staff is well-versed in all facets of genetic toxicology test battery.
The following tests are available: Bacterial Reverse Mutation Test (Ames test); In Vitro Mammalian Chromosome Aberration Test; In Vitro Mammalian Cell Gene Mutation Test; In Vitro Micronucleus Test; In Vivo Mammalian Erythrocyte Micronucleus Test in Mice/Rat; In Vivo Mammalian Bone Marrow Chromosome Aberration Test in Mice/Rat.
All common routes of administration are supported (intravenous, intramuscular, intraperitoneal, oral, subcutaneous, topical). Depending on the needs of the study and unique procedures, other administration routes are supported.
A variety of preclinical investigations using rodents and non-rodents are made possible by the toxicology expertise at VBS. These studies include single dosage, MTD, 4, 13, 26, and 52-week studies, and they are carried out in accordance with international regulatory standards, including ICH, EMA, and relevant standards for the European and US FDA.
Repeat exposure studies in rodents and non-rodents: Acute Toxicity, Local Lymph Node Assay (LLNA), Skin Sensitization (in vitro and in vivo), Sub-acute (1, 2 and 4 week exposures), Sub-chronic (13 weeks), and Chronic Toxicity (26-52 weeks), Carcinogenicity and combined carcinogenicity (104 weeks in rats and 78 weeks in mice).
Toxicology of Development and Reproduction: pre- and post-natal developmental toxicity, one- and multigenerational reproductive toxicity, fertility and early embryonic development, embryo fetal development.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
