Risk Management of Potential drug-drug interaction issues during Discovery and Development of Novel Therapeutic Agents Homework Help

Risk management of potential drug-drug interaction issues during Discovery and Development of novel therapeutic

agents

Group task:

1) Consider the various types of enzymes and biological processes which could be involved in drug-drug

interactions? Include background on methods employed to study these issues. (2000 words)

2) How good are current methods and protocols at predicting clinically relevant effects in patients? (500 words)

3) Devise a strategy for assessing and managing the drug-drug interaction risk posed to and by a novel (acidic)

nonsteroidal antiinflamatory agent. What studies could be undertaken in vitro/preclinically and in the clinic to

assess these risks in the discovery/development process? (2500 words)

Starting References :

Both the EMEA and FDA websites contain comprehensive guidelines on the conduct and interpretation of drug-drug

interaction studies.