I would like to hear your thoughts on what safety margins you believe we need when evaluating results from ex vivo action potential recordings (e.g. GP papillary muscle APD90).
Any references would also be greatly appreciated.
Also, how big an effect do you consider to be relevant?
In models where in-vivo tests are monitored over days and not hours, a tremendous amount of data is generated. How are other researchers handling these large databases and what tools are used to select the subsets of the total data set for analysis?
USDA Policy #3 (Nov 7, 2007) requires the use of pharmaceutical compounds in animals, specifically covered species. Interested in how other pharmaceutical companies and CROs are handling this new guideline with respect to any and all compounds other than NCEs or NBEs that are administered. Materials used for analgesia, anesthesia, euthanasia and any animal health medications would most certainly be pharmaceutical grade, but what about reference compounds, competitor compounds and various pharmacological tool compounds used in the performance of many assays?
Prior to candidate recommendation from discovery, most groups conduct some sort of “ancillary” cardiovascular study. The question is in what model?
Could folks share the in vivo model or models that are typically used (eg. dog, monkey, rat, conscious/anesthetized, etc) to support the advancement of a compound into the toxicology phase of development. Also, if any models used are established in the company, or outsourced.