Week 5 Flashcards
Biopharmaceutical Research and Development Process
- discover
- development
- pre-clinical research
- clinical research
- reviewing and monitoring
discovery
new insights about diseases
screen compounds
development
mechanisms of absorption, distribution, metabolism and excretion
pre-clinical
establish that is it non-toxic to humans
clinical phase I
safety and dosage
63% successful
clinical phase II
hundred of patients
efficacy and side effects
30%
clinical phase III
large study of infected patients
58%
clinical phase IV
thousands
reviewing and monitoring
- federal regulation thought the Health Products and Food Branch
Canadian Agency for Drugs and Technologies in Health
drugs deemed safe must still go through a common drug review for further analysis
patents
drug making is risky and expensive
companies need to ensure a return of their investment
expense of drug making
2.6 billion
can take up to 10 years to get on the market
drug payment: premium
amount that is paid to have coverage
usually based on income
high in NB
drug payment: co payment
fixed
per prescription
drug payment: co insurance
fixed percentage of cost