andrewmy understanding of the heathy patient protocol for phase...

andrew
my understanding of the heathy patient protocol for phase one is toxicity testing unaffected by infected patient blood there are a range of what say 80 ? Cohorts ( recruited paid human guinea pigs) that are given iv recce drips of varying concentration ranges from placebo to minimum through a raft of concentrations to well above suspected required efficacy concentrations 2x - 10 x ? Whateverover a defined period despite recce having nothing to attack the product is known to breakdown by the natural human system and then expelled through natural urine and fecal processes.blood extractions are taken at protocol designed intervals then assessed for a wide range of indicators that would define any issues with kidney , bladder etc other enzyme indicators that if elevated or lowered would indicate a toxicity problemif all blood tests then come back reading benign results the data is collected disseminated to specialists analysed and written up if, as we expect , no toxicity issues are raised , or indeed only modestly at concentration levels well above expected efficacy levels as determined in pre clinical trials, its all systems go to phase 11 application on infected individualsthats how i understand it anywayplease add or detract from this to improve my understanding cheers