Nonclinical Study Design, Monitoring & Evaluation

Nonclinical studies are commonly conducted in animal species and other model systems to ensure the safety of pharmaceuticals. These toxicology safety studies may range from simple, single-treatment experiments to more complex investigations involving multiple dose groups, cohorts of animals, numerous experimental parameters and many time points. In some cases, guidelines are available from regulatory agencies on the conduct of certain toxicology studies, but these guidelines may be open to interpretation and often require the application of expert scientific judgment to ensure an appropriate study design. In other cases, more in-depth investigatory research is needed for which testing guidelines are not available. These types of studies may require expertise in a specific sub-discipline of toxicology (e.g., developmental toxicology, metabolism, or carcinogenesis) to guarantee that the studies are properly designed and executed. In circumstances when multiple studies may be required, these often can be designed in such a way to minimize the use of animals, and thus reduce costs, without jeopardizing the overall outcome of the investigatory program.

Once a study has been designed and the protocol has been set, it is important to monitor the study as it progresses to ensure that once placed at an outside contract research organization (CRO), the study is being conducted correctly and according to protocol. This is of particular concern for more complex studies with lots of moving parts and a high price tag. Understanding of Good Laboratory Practices (GLP) and the experimental procedures to be conducted are particularly beneficial when monitoring a study. Finally, specific expertise may also be necessary to evaluate the results from studies – either those currently in progress or ones that were conducted in years past. Proper interpretation of findings is especially critical for regulatory approval and to ensure the safety of one’s product.

Exponent’s toxicologists have significant expertise in the design, monitoring, and evaluation of a diverse set of toxicology safety studies, including:

  • Acute, subchronic, and chronic toxicity studies
  • Dose range-finding and dose-escalation studies
  • Toxicokinetic and mode-of-action evaluations 
  • Carcinogenicity bioassays
  • In vivo and in vitro genotoxicity assays, including
    • Ames assays
    • Chromosomal aberration assays
    • Micronucleus assays
  • Neurotoxicity and neurodevelopmental studies
  • Developmental and reproductive toxicity studies, including multi-generation studies
  • Juvenile animal studies
  • Biocompatibility and cytotoxicity assays

Exponent scientists have extensive experience in the pharmaceutical industries, academia, and government that can be brought to bear in ensuring that the studies done for our clients are the best they can be the first time around. In particular, our team of scientists has considerable regulatory experience as members of national and international expert committees on a diverse set of toxicology issues related to developmental and reproductive toxicity, endocrine disruption, genotoxicity, mode of action assessments and neurotoxicity testing. Further, our scientists have served on national and international committees involved in the generation and revision of testing guidelines for developmental neurotoxicity testing, and genotoxicity testing.


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