Regulatory toxicology studies to evaluate the relationship between various doses of your drug molecule and adverse events require close collaboration between scientists with multiple levels of expertise from the development company and the contract research organization (CRO). Attentive’s processes ensure transparent communication, collaboration and dialogue that will keep up with your ever-changing needs for lead optimization, candidate selection as well as regulatory-enabling studies.
We partner with our clients during the early phase of Discovery to assess exposure of your test substance/compounds within the body and get an idea of potential toxicity of the compound. The discovery toxicology studies are designed to assess any adverse effects that occur after a single or multiple administrations of the test substance.
Typically, doses are increased in these study types to help identify correlating toxicity. The highest possible repeat dosage level can be identified during a 7 – 14 day study, which in turn is used to extrapolate dosage levels for your subsequent regulatory toxicological study. The Maximum Tolerated Dose (MTD) is the maximum dose that can be given over a specified study period that will not compromise the survival of the test system.
The Attentive Science team routinely conducts preliminary in-vivo toxicity studies to determine appropriate doses for your single and multiple dose studies. We provide flexible study designs during these test substance tolerance assays, to help ascertain relevant multiples of the efficacious dose.
Prediction of acute effects on target organs subsequent to administration of your test substance is an essential data point. The data obtained helps guide your design and dose selection for subsequent sub-chronic and chronic studies. With Attentive, you have additional repertoire of in-vivo test systems to help you evaluate potential acute effects.
In order to provide a standardized electronic dataset for your nonclinical data which will fulfill regulatory electronic common technical document (eCTD) submission requirements, a SEND dataset is required. Use of SEND enhances data review, enables data warehousing, data analysis and data visualization in addition to having a set of controlled terminology for our industry. The FDA requires a SEND dataset for non-GLP studies if those studies are part of your submission, as well as for the customary GLP studies.