Flashcards in Week 1 Deck (20)
Schedule I drugs have ___ abuse potential and an example is:
Heroin, LSD, Ecstacy
Regulatory body is:
Board of nursing
Schedule II meds have a ___ potential of abuse and examples include:
Narcotic: hydromorphone, methadone, oxycodone
Stimulant: amphetamine, Ritalin, adderall
Schedule II meds are allowed how many refills?
Schedule III meds have a ___ abuse potential and examples include:
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:
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.
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?
How long does phase 1 typically last?
How long does phase 2 typically last?
Months to years
Goals of phase 2 include:
1. Establish proof of concept
2. Determine dosage and efficacy
3. Identify common side effects
4. Identify best regimen
What phase is the regulatory phase that achieves regulatory proof, furthers established safety and efficacy, and ascertains toxic effects?
How long does phase 3 last?
Years to decades
When is the new drug application filed?
After phase 3 and before phase 4
What phase is the ongoing, after market phase?
Phase 4- monitors safety of the new drug
Which phase has the highest failure rate?