Wk 7 Drug Development

Question 1

How are drugs defined?

Answer 1

Chemically synthesized w/ defined molecular formula
-cheap
-oral
-short-lived
-limited to certain targets

Question 2

What are biologics?

Answer 2

Made “biologically”
-ideal vs complex targets
-include vaccines
-hard to produce (expensive)
-often recognized and cleared by immune system
-bulky (slow/poor penetrance)

Question 3

Describe stages of drug development

Answer 3

1. drug discovery
2. pre-clinical development
3. clinical development
4. regulatory approval

Question 4

Describe the phases of drug development during stage 3, clinical development

Answer 4

phase 0: effect on body
I: safety in humans ~70% move tro next phase
II: effectiveness treating diseases - dosing, ~30% to next phase
III: larger scale safety and effectiveness, ~50% to next phase
IV: long term safety

Question 5

What is IND?

Answer 5

Investigational New Drug
-application submitted to FDA before phase I

Question 6

What is NDA?

Answer 6

New Drug Application
-submitted to FDA
-~$3M fee
~1-2 years for review