BLG 699 Lecture Notes - Lecture 1: Health Canada, Biopharmaceutical, National Research Act
15 Apr 2018
School
Department
Course
Professor
Document Summary
Lecture 1 summary: discovery preclinical clinical marketing application approval, the overall process takes 10 12 years (could go up to 20-25 years) and costs above. Lecture 1 extra points: canada health canada; u. s. - fda (food and drug administration, before 1960s there was no regulations! Drug (according to fda definition) -> an active ingredient that is intended to furnish pharmacological activity or other direct effect in: To affect the structure of any function of the human body, but does not include intermediates used in the synthesis of such ingredient. (other than food) intended to affect the structure or any function of the body. Intended for sure as a component of a medicine but not a device or a component, part or accessory of a device. Generic name (atorvastatin the chemical name of a drug) Chemical name (formula: traditional chinese medicines san qi-panax notoginseng :
