Test 1 part VI Flashcards
Federal food, drug, and cosmetic act of 1938
required that new drugs be safe as well as pure but did not require proof of efficacy
the federal food drug and cosmetic act of 1938 was a response to what?
deaths associated with the use of a preparation of sulfanilamide marketed before it was adequately tested
Kefauver Harris amedments of 1962 to the food drug and cosmetic act was in response to?
teratogenic drug disaster of thialidomide
what is the role of the FDA
-oversees drug evaluation in the US and grants approval for marketing of new products
-responsible for aspects of food regulation in collaboration with the U.S. dept of agriculture
how long do new drug clinical trials in human subjects take?
4-6 years
T/F: new drug clinical trials are done concurrently with chronic safety testing in animals
true
what all is required before a new drug can undergo clinical trials in human subjects?
- informed consent of the patient
- approval from FDA and IRB of the facility that is conducting the clinical trial
Lifetime of a drug patent
20 years
when does a patent “lifetime” begin?
at submission, which is usually after the drug screening phase.
patent approval of a new drug can take __________ years or longer
5
at what point can a generic version of a new drug be marketed by other pharmaceutical companies without fee or penalty
once the drug patent expires
trademark drug name
is the drugs proprietary tradename
usually registered and may be legally protected
diprivan is the ________________ name for propofol
trademark
how many phases of clinical trials in human subjects are there?
4
phase I of human clinical drug trials
- determines the safe clinical dosage range
- non-blind study
- predictable toxicities are detected
- uses 20-100 healthy volunteers
- measurements of absorption, half-life, and metabolism are done
what phase of human trials is the drug studied in patients with the target disease to determine its efficacy
phase II
which phase of human drug trials has a high rate of failure?
phase II
how many drugs move from phase II to phase III in human clinical trials
25%
which phase of human control trials are conducted in a special research center by specially trained clinical pharmacologists
phase I
which phase of human clinical trials are conducted in special clinical centers (like university hospitals)
phase II
which phase of human drug trials is single blinded
phase II
how many people are typically involved in a phase II human clinical trial
100 -200
how many people are involved in phase III human clinical trials
1000’s (with the intended dz)
what is the purpose of phase III human clinical trials
to confirm and safety and efficacy by minimizing erros caused by placebo effects
what research technique is used in phase III human clinical trials
double blind and crossover
which human clinical trial phase is the most expensive
phase III
where are phase III human clinical trial performed
in the environment of treatment for the disease
which phase of human clinical trails can the application be made to the FDA to take the drug to market (under normal conditions)
after phase III as long as results meet expectations.
under what situation may the FDA approve controlled marketing of drug prior to completion of phase III trials
for serious diseases where there is an urgent need of pharmacological therapy
under what situation may the FDA permit controlled marketing of a drug prior to completion of phase II trials
for life threatening diseases
approximately ___________% of drugs in phase III human clinical trials are involved in early controlled marketing
50
when do phase IV human clinical trials occur
after marketing approval
which phase of human control trials is monitoring the safety of the new drug under actual conditions of use in large numbers of patients
phase IV
what phase of human clinical trials may low incidence toxicities (1 in every 10,000) become apparent
phase IV
how long does phase IV human clinical trials take
no fixed duration of time
drug A has therapeutic index of 3 and drug B has a therapeutic index of 10, which drug is safer?
drug B
an inactive precursor chemical that must be absorbed, distributed, and converted to an active drug is a ____________________
prodrug
constitutive effect
basic functioning of receptors without any other additives to their functioning
R(active) + R (inactive) will produce a _________________ effect
constitutive
___________________ is the first of a complex sequence of steps in a drug producing an effect
drug binding
what are two examples of how drug response and effect could be altered by changes in the components responsible for completing the DR complex
- wrong diagnosis (giving abx for viral infection)
- compensatory mechanism activity (kidney increase BP in presence of antihtn)
changes in tissue or plasma binding can change the _______________ of a drug
volume of distribution
abnormal accumulation of fluid (edema, ascites, pleural effusion) can markedly ________________ the volume of distribution of a drug
increase
impairment in the function of which organs may cause abnormal clearance of a drug
liver
kidney
heart
hepatic disease has been show to decrease ____________ and prolong ____________ of many drugs
clearance; 1/2 life
__________________ will occur between absorption and elimination
biotransformation
in what situation may a drug compound have a phase II biotransformation reaction before phase I for elimination?
if the compound naturally includes a functional group
to decrease the effects of the variable and natural hx of most diseases in human trials of new drug, what should be done?
evaluate a large enough population of subjects over sufficient period of time and use cross over design
the placebo response can contribute to what factor in human evaluation of a new drug
subject and observer bias
a single blind study in human evaluation of new drug can be used to minimize _____________________
subject bias
a double blind design study in human evaluation of new drug can be utilized to minimize _____________________
observer bias
human clinical drug trials is governed by the ethical principles of the __________________
1966 declaration of helsinki
what are the 3 components (in order) of G-protein signaling
- Extracellular ligand is selectively detected by a cell-surface receptor which triggers the activation of G protein in the cytoplasm
- the activated G protein changes the activity of an effector element (usually enzyme or ion channel)
- the effector element changes the concentration of the intracellular 2nd messenger
