Thread by @jaderesearch

@ChuckCallesto #RussianRonJohnson plagiarizes @GovRonDeSantis who said he would do that. As a Medicinal Chemist who taught drug dev process to Biomedical Scis, MDs,PhDs, PharmDs, I provided a summary. Bottom line #WarpSpeed cut time to market fr 8-15yrs to 2yrs, limiting data #BlameTrump @GOP

@ChuckCallesto @GovRonDeSantis @GOP Drug dev begins w Rational Drug Design of likley candidates, based on Structure Activity Relationship models. Then lab, bench scale prep, efficacy tests, in vitro, then in vivo. Likely candidates tested in rats to get ADME-Tox data.Absorption, Distribution, Metabolism, Excretion

@ChuckCallesto @GovRonDeSantis @GOP 3/ Safety & efficacy tested in animal models (all research animals protected under IACUC protocols under USDA regs). If safe & effective, plans to proceed to Clinical Trials, under @US_FDA guidelines governed by 45 CFR 46 Human Subjects Research protection regs. CT Phases I-IV.

@ChuckCallesto @GovRonDeSantis @GOP @US_FDA 4/ Phase I ClinTrial Test on healthy subjects for safety, the most robust of our species, young adult males. If no issues with safety, trials can proceed to Phase II, testing drug under carefully designed protocols on registered patients, w informed consent, closely monitored.

@ChuckCallesto @GovRonDeSantis @GOP @US_FDA 5/Phase II has several hundred patients w disease, larger numbers, treated w dose determined to be safe in Phase I. Monitored closely several months or years.Phase II has more patients than earlier, monitored longer, data analysed, but not enough to ensure safety. Need Phase III

@ChuckCallesto @GovRonDeSantis @GOP @US_FDA 6/ Phase III Involves many patients, 3000 or more. trials can last years. Move into randomized trials w placebo. @US_FDA usually requires a Phase III trial before approval of a drug. This process often takes several years, cut to 2. @SenRonJohnson Read thread above. #WarpSpeed

@ChuckCallesto @GovRonDeSantis @GOP @US_FDA @SenRonJohnson That is the normal procedure. I'll outline what I know from public info about development of #COVID19Vax in a separate thread.

@ChuckCallesto @GovRonDeSantis @GOP @US_FDA @SenRonJohnson @threadreaderapp please unroll