Drug Development Flashcards
What is drug discovery?
What are the beginning steps of drug development?
How are most drugs developed or discovered?
What is drug screening?
What’s the objective to preclinical safety and toxicity testing?
What are the various goals of preclinical and toxicity testing?
What are the safety tests that are carried out during preclinical testing ?
What are the limitations of preclinical testing?
How rigorous are clinical trials?
What must notice of claimed investigational exemption for a New drug (IND)?
In each phase of clinical trials, patents or volunteers…
Give a description of clinical trials
What are subject & observer bias?
Describe the double observer bias
What are Prephase 1 clinical trials?
What are phase 1 clinical trials?
Describe phase 2 clinical trials
What do phase 3 clinical trials?
When does new drug application occur (NDA)?
Describe phase 4 studies
Describe the life cycle of drug approval
What are the requirements of drug labeling?
Describe off label use
Describe the black box warning
What are orphan drugs?
What is fast track status?
What is pharmacoepidekiology?
What are the controlled substances FFA keeps in minds for potential of abuse?
What are the restrictions regarding prescription writing?