FDA regulation, trials, basic pharmacological terms Flashcards
Cp
plasma concentration. Cp vs time ~pharmokinetics.
MEC
Minimum effective concentration.
Time of onset
Time to reach MEC
Duration of action
Time above MEC
Therapeutic window or therapeutic index
Range between MEC and adverse response MEC
Pharmacodynamics:
what the drug does to the body (pathophysiology)
Pharmacokinetics:
how the drug moves through the body (pharmacology)
What is bioavailability?
How much drug reaches the target organ.
What is absorption?
Time from route of administration into blood.
Distribution is:
rate of drug movement from the blood into the tissues.
What is the difference between side effects and extension effects?
Side effects are reactions at a different site than target site. Extension effects are seen above the adverse reaction MEC at the target site (overdosage). Both are predictable based on mode of action of drug.
What three huge processes does the FDA oversee?
Drug approval (trails)Generic equivalencyControlled substance classification and Rx/not
What process does the state government oversee?
Who can prescribe (with the exception of controlled substances which is regulated by the DEA).
What are relevant components of an animal trial?A human trial?
5-8 years, $30-60 million, safety, efficacy, try to establish dosage. 2-10 years. $100-200 million. 3 phases.
Phase I trial
Small pool of healthy male volunteers (<100), establish safety, dosage
Phase II trial
Larger pool of volunteers (200-300). Compare vs existing therapy or placebo.
Phase III trial
Double blind study vs. placebo or existing treatment.
What is phase IV? What is the purpose
Post-approval tracking. Physicians report low-incidence adverse responses. To find:1 in 100 incidence need 1800 patients1 in 1000 incidence need 18,000 patients1 in 10,000 incidence need 180,000 patients
How do generic drugs compare to name brand? What differs?
They have exactly the same dosage, intended use, therapeutic effects, side effects, route of administration, risks, safety, and efficacy as the original drug.Most generic brands are bioequivalent. The mean bioavailability variation between brand and generic products tested in the United States since 1984 is less than 4%.
What is bioequivalency?
Bioequivalent drug products have similiar bioavailability. The formulation is tested by the FDA to ensure equivalency.
What is Therapeutic equivalency?
Same therapeutic effect between two drugs. Requires clinical testing in the same individual. Generally not tested by the FDA, under the assumption that bioequivalent drugs will also be therapeutically equivalent.
What is the critical difference between a health claim and a structure function claim? Which requires FDA approval?
A health claim claims to cure a specific, named disease (eg osteoporosis). A structure/function claim claims describes the role of a substance intended to maintain the structure or function of the body (eg calcium may help strengthen bones). Health claims require FDA approval. Structure/function claims do not. [Any structure-function claims made on the label must contain this disclaimer:“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”]
Schedule I:
High abuse potential, no currently accepted medical use; not for prescription use, but allowed for research and instructional use. [Consists of: 80-90 opiates / opium derivatives (heroin); ~30 hallucinogenic substances (LSD, MDMA-ecstasy, other designer drugs); mescaline, peyote, marijuana, psilocybin; ~10 depressants (methaqualone) and stimulants].
Schedule II:
Accepted medical use, high abuse potential with severe liability to cause physical or psychological dependence. [Consists of: opioid analgesic drugs (morphine, codeine, oxycodone, hydrocodone non-opioids, hydromorphone, meperidine, methadone); stimulants (methamphetamine, amphetamine, cocaine, methylphenidate); barbiturates (pentobarbital, secobarbital)].
