PCL102H1 Lecture Notes - Lecture 25: Blind Experiment, Vito Russo, Health Canada
29 Apr 2016
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-> after preclinical testing/before phase 1 and after phase lll. 1960s there was a drug against morning sickness for pregnant women called thalidomide; many children were affected (lack of limbs); thalidomide causes teratogen (improper development of embryo) in rabbits and primates and is non-teratogenic in mice and rats. Frances kelsey (canadian fda) refused approval of thalidomide claimed more testing was needed. Thalidomide tragedy led to more strict safety testing and led to new product regulations such as proof of efficacy/ new drugs needing approval before being put on market. Thalidomide was later returned to clinical use for infectious diseases such as leprosy and aids; also used in women of childbearing age. Before clinical trial begins; request permission to distribute drug to investigators (scientists/doctors) named in application. Production info- how was the drug made? dosage form (pill/liquid); information about the investigators running the trial.
