Discovery

CEBIS USA supports preclinical drug development with analytical method development and validation, impurity profiling and characterization, toxicology, drug metabolism, pharmacokinetics and bioanalysis.

• Single-dose and maximum tolerated dose studies
• Repeat-dose studies, including sub-acute, sub-chronic and chronic toxicity
• Skin sensitization and local lymph node assays
• Carcinogenicity studies
• Developmental and reproductive toxicity, including fertility, embryonic development, and pre- and post-natal assessments

Available tests include bacterial reverse mutation (Ames), mammalian chromosome aberration, mammalian cell gene mutation, and in vitro and in vivo micronucleus tests. Study design and administration routes are selected around the needs of the development program and applicable regulatory requirements.