3/2/2024 0 Comments M3 data recovery redditIn these cases, long-term toxicity testing starting in juvenile animals can be appropriate in some circumstances (see Section 12). There can be cases where a pediatric population is the primary population, and existing animal studies (toxicology or pharmacology) have identified potential developmental concerns for target organs. Complete histopathology data from the non-rodent should be available within an additional 3 months. ![]() For serious or life-threatening indications or on a case-by-case basis, this extension can be supported by complete chronic rodent data and in-life and necropsy data for the non-rodent study. In some circumstances clinical trials of longer duration than 3 months can be initiated, provided that the data are available from a 3-month rodent and a 3-month non-rodent study, and that complete data from the chronic rodent and non-rodent study are made available, consistent with local clinical trial regulatory procedures, before extending dosing beyond 3 months in the clinical trial. ![]() ![]() Clinical studies of less than 14 days can be supported with toxicity studies of the same duration as the proposed clinical study. In the United States, as an alternative to 2 week studies, extended single-dose toxicity studies (see footnote c in Table 3) can support single-dose human trials.
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