Week 1 Flashcards
Schedule I drugs have ___ abuse potential and an example is:
High
Heroin, LSD, Ecstacy
Regulatory body is:
Board of nursing
Schedule II meds have a ___ potential of abuse and examples include:
High
Narcotic: hydromorphone, methadone, oxycodone
Stimulant: amphetamine, Ritalin, adderall
Schedule II meds are allowed how many refills?
Zero
Schedule III meds have a ___ abuse potential and examples include:
Moderate
Narcotic: Tylenol with codeine, buprenorphine
Others: ketamine, Marinol, anabolic steroids
Schedule III meds may be filled up to:
5 refills in a 6 month period
Schedule IV drugs have a ___ potential for abuse and examples include:
Low
Lorazepam, Valium, tramadol
Schedule IV meds may be refilled:
Up to 5 times in a 6 month period
When is the Investigational new drug app filed to FDA?
After preclinical trials and before phase I clinical trials
Preclinical trial can take ___ and includes ___ testing.
Several years Animal testing ( no human testing)
What phase of drug trials has a few number of healthy participants ( less than 100), establishes tolerance and identifies side effects?
Phase I
How long does phase 1 typically last?
Months
How long does phase 2 typically last?
Months to years
Goals of phase 2 include:
- Establish proof of concept
- Determine dosage and efficacy
- Identify common side effects
- Identify best regimen
What phase is the regulatory phase that achieves regulatory proof, furthers established safety and efficacy, and ascertains toxic effects?
Phase 3
