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PHAR 100 midterm exam with correct answers
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PHAR 100 midterm exam with correct answers
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PHAR 100 midterm exam with correctanswers
pharmacology - Answers -the science of drugs, including their uses, effects, and
mechanisms of action
historical influences that shaped modern pharmacology - Answers -1. discoveries made
by ancient civilizations
2. the role of poisons in history
3. influence of religion
drug - Answers -any substance received by a biological system that is not received for
nutritive purposes, and which influences the biological function of the organism
categories of drugs - Answers -1. drugs that act on the brain
2. drugs that act on infectious diseases
the 5 steps of drug development - Answers -1. drug discovery
2. preclinical studies
3. clinical studies
4. health Canada and manufacturing
5. post market surveillance
drug discovery - Answers -- first step of drug development
- basic research and discovery of target
- step 1: identification of the target
- step 2: studying the target
preclinical studies - Answers -- second step of drug development
- tests if the drug is safe and effective
- ranges from molecular and cellular studies, to tissue and whole animal studies
- 2 categories:
- pharmacology studies determine the drugs mechanism of action
- toxicology studies determine the drugs risks and harmful effects
clinical trials part 1 - Answers -- step three of drug development
- the initial steps before human testing
- 2 things must be submitted to government
- proof of safety and efficacy of the drug from preclinical studies
- the methodology of the clinical trials in humans
,- the submission is evaluated by scientists and if they are satisfied investigators (usually
clinical pharmacologists) can test the drug in humans
clinical trials part 2 - Answers -- step three of drug development
- 3 phases
clinical trials phase 1 - Answers -- evaluates ADME and adverse effects of the new drug
- tests 1 or 2 doses to determine tolerability
- conducted on healthy volunteers
- 20 to 80 people
clinical trials phase 2 - Answers -- determines whether the drug is effective
- conduced on patients with the disease the drug is intended for
- 100 to 500 people
clinical trials phase 3: randomized control trials (RCT) - Answers -- determines how safe
and effective the drug is compared to no treatment (placebo) or gold standard drug
- months to years long
- large diverse group
- 1000+ people
- most expensive phase, upwards of 50 million dollars
- 3 larger stages:
- determining enrolment prior to the study
-allocating participants and conducting the trial
-monitoring and analyzing the results
- most likely phase for a drug to fail
clinical trials phase 3: determining enrolment prior to the study - Answers -- stage one of
phase 3 clinical trials
- target population is the group of patients for which the drug is intended
- study population is a subset of the target population that meets all the required criteria
(inclusion/exclusion) and consents
clinical trials phase 3: allocating participants and conducting the trail - Answers -- stage
two of phase 3 clinical trials
- double blind design: no one knows who's in the treatment group vs control group
- randomization: patients are randomly assigned to a group
- control: efficacy and safety of the drug has to be compared to a control drug, either a
placebo or gold standard drug
clinical trials phase 3: monitoring and analyzing the results - Answers -- stage 3 of
phase 3 clinical trials
- outcome: which drug was more effective
- account for: patient compliance, change in quality of life, and trial statistics
health Canada review and manufacturing - Answers -- fourth step of drug development
, - manufacture submits the new drug application to the regulatory body containing trial
results
- results are reviewed, and if deemed effective with acceptable toxicity, its approved
generic vs brand name - Answers -- chemical names too complex so a drug gets a
generic name
- the manufacture also applies for a brand name and gets a patent for 20 years
- when the patent expires, other manufactures can use and rebrand the drug
- the generic and brand name MUST contain the same active ingredient, this is called
bioequivalence
post market surveillance - Answers -- fifth step of drug development
- "phase 4" clinical trial
- delayed, or less frequent risks may be missed in phase 3 so trials are still conducted
after the drug is released to market
the 4 factors that influence drug action - Answers -1. drug targets
2. drug response
3. efficacy and potency
4. therapeutic range
drug targets - Answers -- drugs are designed to interact with one selected target in the
body, which is most often a receptor.
- agonists are drugs that bind to and stimulate a receptor
- antagonists are drugs that block the response at a receptor
drug response - Answers -- dose response relationship: generally the intensity of the
pharmacological effects produced by a drug increases in proportion to the dose, which
is defined by the amount of drug taken
- for a drug to receive its desired response, many receptors need to be activated at
once
- dose response curve: represents how much of a drug you need in the body to see a
specific effect
efficacy and potency - Answers -- properties of a drug that describe its ability to produce
a response
- efficacy: the maximum pharmacological response that can be produced by a drug
- potency: the dose of a drug required to produce a response of a certain magnitude,
usually 50% of the maximum response
therapeutic range - Answers -- the dose that keeps the blood concentration of a drug
above the concentration that produces a desirable response, but below the
concentration that produced a toxic response
pharmacokinetics - Answers -- the movement of a drug into, through, and out of the
body
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