BLG 699 Lecture Notes - Lecture 3: Allergen, Center For Drug Evaluation And Research, Interferon
Document Summary
Blg 699 social factors in drug development. Ok, we discovered the drug, now what are the next steps: there are legislations that require drugs to be. Role of regulatory agencies: developed, tested (on animals/humans, trialed, and manufactured in accordance to guidelines so that they are safe and patients" wellbeing is protected. (ng, 2009, ultimate goal: safe and effective drugs. What are regulatory standards: drugs are tested on animals by following glp (good lab practice, drugs are tested on humans by following gcp (good clinical practice, drugs are manufactures by following. Health products and food branch (hpfb) of health canada * Ministry of health and labor welfare (mohlw) with pharmaceutical agencies and. Opportunity markets (om) or merging markets: asia, latin america, central and eastern europe, middle east and africa have independent nras. Nb: companies/manufacturers must receive the approval of these regulatory agencies; global projects would need the approval of all the regulatory agencies involved.
