lec 9-10. drug development

Question 1

stages of development of a new drug

Answer 1

1) drug discovery phase
2) pre-clinical trial
3) clinical development

Question 2

tests for drug safety during lead selection

Answer 2

1) ames test - detect mutagenicity
2) clastogenicity test - genotoxicity test
3) arrythmia biomarker - hERG channel assay
4) repeated administration - after 14 days to check toxicities

Question 3

goals of non-clinical safety evaluations

Answer 3

• eliminate genotoxicity
• determine max non-toxic dose
• test pharmacokinetics

Question 4

phases of clinical trials

Answer 4

phase 1 - first in man, 20-80 people, toleration and pharmacokinetics

phase 2 - 100-300 people, test efficacy and establish dose for next phase

phase 3 - thousands of people, compare new drug with alternatives

phase 4 - many thousands of people, detect rare or long term adverse effects

Question 5

immunotherapies

Answer 5

checkpoint inhibitors - release break on T cells

CAR T therapy - supercharge immune system

cancer vaccines - train body to protect itseld