PHAR 100 Lecture Notes - Clinical Trial, Asthma, Osteoporosis
Document Summary
Preclinical trial show on smooth muscle; test on animals, etc. toxicity screens: in vitro, in vivo, carcinogenic, teratogenic, etc. Phases of a clinical trials in drug development. Phase i one or two doses in healthy volunteers: absorption, distribution, elimination and adverse effects (limited) Phase ii try on limited number of subjects: short-term efficacy study. Phase iii long-term study for efficacy and safety. (2000, 20 000) depending: randomized controlled trials. Phase iv often referred to as post-market surveillance look for possible rare toxicities. Include both placebo: can have side effects drug companies: compared to placebo new drugs look good, whereas compared to best on market not as good best available drug or accepted treatment. Ie. accepted standard of care placebo may not be ethically acceptable if there is treatment for the disease cannot withhold therapy. Randomization allocation of patients to the different treatments should not have bias use table of random numbers or allocated by computer.