[1] General Principles of PT Pharmacology (CH1) Flashcards
contrast pharmacology to pharmacy
pharmacology is the STUDY of drugs
pharmacy is the DISPENSING of drugs
pharmacology can be divided into what 2 categories?
pharmacodynamics and pharmacokinetics
define pharmacodynamics and provide examples
pharmacodynamics is what the drug does to the body
- ie. MOA, effects
define pharmacokinetics and give an example
pharmacokinetics is what the body does to the drug
- ie. ADME (absorption, distribution, metabolism, excretion)
when under the topic of drug nomenclature, compare the “generic name” of a drug to the “trade (brand) name” of a drug
generic names of drugs are nonproprietary when compared to the trade/brand name, which is proprietary and is assigned by the pharmaceutical manufacturer
- generic name: diazepam
- trade/brand name: Valium (TM)
who monitors the development and approval of a drug?
the FDA is who monitors it, a branch specifically in the FDA called the CDER is charged with this.
preclinical trials are conducted in ….
animals (small –> big)
what is an IND? what is its purpose?
Investigational New Drug Application
- after preclinical trials, the IND application is submitted to the FDA for administration of the drug in humans
clinical trials are conducted in…
humans
describe how clinical trials in humans works
4 phases ( I, II, III, IV )
- you progressively work your way up in subjects/patient population
- priority shifts from safety –> effectiveness for disease state –> adverse effects
NDA comes after Phase III
- you conduct Phase IV
in Phase 1 of clinical trials, describe the population you are working with and what you are looking for
- in phase 1 you are working with < 80 HEALTHY volunteer subjects
- safety is the biggest concern
- other factors you are acknowledging are the pharmacokinetic profile & dose
in Phase 2 of clinical trials, describe the population you are working with and what you are looking for
- in phase 2 your patient population grows but is still < 300
- the patient population shifts from HEALTHY volunteers in phase 1 to a slightly larger patient population that POSSESSES the disease
- you are monitoring the effectiveness for disease state in the phase, as well as safety
in Phase 3 of clinical trials, describe the population you are working with and what you are looking for
- in phase 3 your patient population grows but is still < 5000
- larger patient population that POSSESSES the disease
- still addressing the effectiveness for disease state and safety, but you are now taking into account ADVERSE EFFECTS due to a larger patient population
you have finished conducting Phase 3 of clinical trials, what happens next?
new drug application (NDA) occurs after Phase 3, now its Phase 4
in Phase 4 of clinical trials, describe the population you are working with and what you are looking for
also called “post-marketing surveillance,” your population grows even more, pretty much to see if there are any adverse effects or reactions in a patient population that provides more subjects than phase 3
- you look for effectiveness comparisons, safety, rare adverse rxns
what is the purpose of Phase IV?
the purpose is to monitor safety in the general population
- going off Phase 3 ( x > 5000), Phase 4 is able to potentially detect very rare adverse effects that otherwise wouldn’t have been caught in a smaller patient population
human testing (phase 1-3) may take how long?
6-9 years
only about 1 in every ___ drugs synthesized by a MFR will ever be released as a new drug
1 of every 1000 drugs
drugs receive FDA approval for specific indication… what does this mean?
this means a specific sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure.
what does the term “off-label” mean?
“off-label” use refers to the ability of a physician to prescribe drug(s) for
other “off-label indications”
drug companies are really competitive…so what would be fair to assume that when a new medicine is discovered early in the timeline?
patent protections are quickly filled
- US patent application and issue
- foreign patent applications filed and issued
the generic substitution for a brand name drug may be approved when…
brand name MFR patent expires
a generic drug must undergo tests to establish bioequivalence when substituting for a brand name drug, why?
how is this done?
- bioequivalence means that the generic form of the drug contains the same type and amount of active ingredient as the brand name
- generic drug MFR files an abbreviated NDA with the FDA
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