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Search results with tag "Repeated dose"
M3 R2 Step 4 June 11 2009 - ICH
database.ich.orgdose for acute and repeated-dose toxicity studies in any species. To support Phase III clinical trials for the United States, dose-limiting toxicity generally should be identified in at least one species when using the 50-fold margin of exposure as the limit dose. If this is not the case, a study of one-month or longer duration in one
OECD Test Guideline 407: Repeated Dose 28-day Oral ...
ntp.niehs.nih.govcomprises the basic repeated dose toxicity study that may be used for chemicals on which a 90-day study is not warranted (e.g. when the production volume does not exceed certain limits) or as a preliminary to a long-term study. The duration of exposure should be 28 days.