BIO375H5 Lecture 1: BIO375 Lecture 1.1
Document Summary
In canada, following a license the firm publishes a product monograph : product monograph contains information on how to use the drug in canada, product label refers to the exact patients who can be treated, product monograph guidelines. Indications in clinical use claims about drug benefit: also indicates who and how drug is to be used tells expected benefit, off-label used sparingly and open to challenge by insurance company. Chemotherapy: severe side effect profile real patients willing to take chance of benefit, phase 2 pilot study despite toxicity, determine whether or not we want to commit resources to the project, small group of patients tested. We look at the effect on the number of brain lesions n =10 which is initial sample. Is this convincing data of a cure: large or small sample size depends on disease you"re studying. Per protocol analysis: per protocol analysis fail to include patients that have dropped out of study.
