CRO · Nonclinical and toxicology
There is work to do before anything reaches a person.
We design and manage efficacy and mechanism work in cells and animals, and the safety and toxicology studies that go with it. What nonclinical safety work is needed, and when, is set out in ICH M3(R2); toxicology studies intended for a regulatory submission must be run at a designated test facility under the OECD Principles of Good Laboratory Practice (GLP) and Korea's MFDS GLP regulation. AriBnC does the study design, the selection and oversight of the test facility, the review of the data, and the work of carrying that result into the human studies and the dossier that follow.
What happens at the nonclinical stage
Which of these a material needs differs case by case. The first conversation is about deciding which studies are actually required.
| Category | What it covers | Standard |
|---|---|---|
| In vitro activity | Activity at cell level, exploration of the mechanism, and the basis for a dose range | Set by the purpose of the study |
| In vivo mechanism and efficacy | Mechanism and efficacy in animal models, run under approval from the institutional animal care and use committee (IACUC). | IACUC approval |
| Safety and toxicology | Single- and repeat-dose toxicity, genotoxicity, safety pharmacology and related studies. Anything intended for a submission is run at a GLP-designated test facility. | OECD Principles of GLP · MFDS GLP · ICH S-series |
| Specification, marker compound and analytical method | Choosing the marker compound, fixing the manufacturing process, and developing and validating the analytical method. Everything that follows rests on this specification. | Market-specific requirements |
| Nonclinical data review | Reviewing data you already hold against the requirements of the target market, and separating what is missing from what has to be repeated. | Market-specific requirements |
Which toxicology studies are needed, and for how long, depends on the material, the route, and the target market.
Tell us what data you hold and your target market, and the study lead will come back within two to five business days with the nonclinical scope it calls for.