PHARM 100 Pharmacology_Exam. Module 1- Module 6
Pharmacology Exam
Module 1:
1. Discuss the influence of drug use by ancient civilizations on modern pharmacology
⟶ Ancient China (2700 B.C.)
• Drug Ma Huang treated coughs, influenza, and fevers
• Ephedrine was isolated from it to treat asthma, and its derivative used as a
decongestant
⟶ Ancient Egypt (1550 B.C.)
• Papyrus (documents) contained observations on use of drugs, particularly on
purgatives, used to cause bowel movements
• Recommended Senna to treat sue, that are still available today
Ancient Greece (380 B.C.)
Theophrastus, a pupil of Aristotle, wrote a textbook on therapeutics that included
opium.
Opium was found to contain 10% morphine, which is able to relieve pain of very
great intensity.
2. Describe the process of developing a new drug, the conduct of clinical trials, and the
techniques used in drug advertising
1. Drug discovery
⟶ Research and discovery of target – discovery of lead compounds
⟶ Preclinical testing – determine safety and potential
efficacy Two main categories of preclinical studies exist:
Toxicology studies – determine effect of new drug on organ systems other
than targeted organ (Adverse effects).
Pharmacology – determine detailed mechanism of action of new drug (how the
drug functions).
2. Clinical trials
⟶ Phase 1 – safety and potential efficacy
⟶ The absorption, distribution, elimination and adverse effects of the new drug are
carefully studied. Usually one or two doses of the new drug are administered, and
the tolerability of the drug is determined.
⟶ Phase 2 – safety and tolerability
Conducted in patients who have the disease for which the disease is designed to
treat. Determines the effectiveness of drug in treating condition it is
recommended for, in a limited number of people.
⟶ Phase 3 – effectiveness and safety
These trials, often called controlled randomized clinical trials, are one of the main
studies used for the licensing and marketing of the drug. These studies test the
drug in a larger number of people (usually one thousand or more) to obtain more
information on the safety and efficacy of the drug. Determine if drug is safe and
effective.
Parts of a phase 3 clinical trials:
,PHARM 100 Pharmacology_Exam. Module 1- Module 6
Target population = group of patients for whom drug is intended.
Inclusion/Exclusion criteria = patients selected from target population according
to strict set of inclusion and exclusion criteria to eliminate all variables other than
drug under study. Criteria must define characteristics of patients who are not
eligible to be part of trial (e.g. patients with multiple diseases could influence
results).
Ethical considerations and consent = Informed consent must be obtained before
participation in clinical trial. Purpose, procedure, potential risks, benefits must be
understood by patient. The trial methodology and informed consent documents
are reviewed by an independent Institutional Ethics Review Board to protect
rights of participants.
Study population randomized allocation = patients recruited for study are assigned
to experimental or control groups by chance, randomization. Patients with
different characteristics are equally distributed between treatment and control
groups, maximizing comparability of groups removing bias in assigning patients
to groups.
Treatment = patients in treatment group will receive experimental drug.
Control = experimental drug has to be compared to a control drug, either a
placebo or a gold standard drug depending on disease.
,PHARM 100 Pharmacology_Exam. Module 1- Module 6
Placebo = (inert substance masquerading as a drug) tablet that doesn’t contain any
active drug but is identical in appearance, colour, taste, size to tablet containing
active drug. People anticipate that drug will ease ailment, making it actually work
just because we believed it. (placebo response can be as high as 35%)
Gold standard drug = drug accepted by medical community as best treatment
available for disease at the time. It is unethical to not give this drug is available.
Blinded assessment = Neither investigator nor study subject is aware of
treatments study subject is assigned to, eliminating bias.
Outcome = results of treatments should be measured in objective and reliable
manner.
Compliance = For results to be valid, patient compliance must be determined.
Counting remaining tablets at each clinic visit measures overall compliance.
(compliance can be as low as 50-60-%)
Quality of life = measure impact of drug or treatment on quality of life of
participants.
Analysis of results = experimental drug results must be compared to control drug
results using statistics. Statistics can determine if difference between drugs is real.
Or by chance.
3. Health Canada/FDA approved Drug
⟶ Health Canada Review and Manufacturing – Drug approval and production
Health Canada review: After initial phase 3 trials, manufacturer will submit to
regulatory body a new drug application containing detailed results of clinical
trials. Results are reviewed by regulatory scientists. If drug is effective, toxicity
is acceptable, it is granted approval.
Manufacturing: Generic vs Brand name: Since drugs formal chemical name is too
complex for general use, generic name for drug is selected. Manufacturer will
apply for a patent with a brand name for drug, which will give company exclusive
rights to market drug for 20 years (starting from when patent is filed in preclinical
development phase so the effective patent life of a drug is in range of 10 to 12
years). After patent on a drug expires, other manufacturers can make copies of
original drug and sell it under their own brand name.
Bioavailability studies = New brand name drugs and generic drug will contain
identical active ingredient as original brand name drug, in same amount and
usually in same dosage form. Comparative bioavailability study is conducted to
compare blood levels after administration of both drugs to healthy volunteers to
ensure drugs are bioequivalent.
, PHARM 100 Pharmacology_Exam. Module 1- Module 6
⟶ Phase 4 – long-term safety, referred to as post-marketing surveillance
Risks that are delayed or less frequent may be missed in the phase 3 trial.
Surveillance of the effects of drugs are required after drug is released for general
use.
Drug advertising:
For every dollar spent on drugs in Canada, 25 cents go to promotion of drugs, nearly all of which
goes to enticing physicians to prescribe drugs. Persuasion is the main purpose of drug
advertisements so a major deficiency in drug advertising is the lack of information on the
adverse effects of the drug.
Advertising Techniques:
Techniques used to try to convince physicians and patients to adopt a specific drug.
1. Catch audience attention = ad designed in a way to draw eyes of audience.
2. Use of celebrities/authorities to endorse products = people often trust authorities or
admire celebrities, which can be exploited by drug ads.
3. Fear = tactic is to illicit fear in person, then provide a drug that will help abate that fear.
4. Offer an easy solution to problems = technique focuses on how easy it is to treat
disease with drug.
5. Before-after technique = ad has person in undesirable circumstance, then ad will have a
following picture of same person after taking drug who is now in desirable circumstance.
6. Discredit drugs produced by other manufacturers and praise your own = make new drug
look better than other drugs on market that treat same condition as new drug.
3. Explain how drugs act on the body to produce their effect, and explain why drug
variability exists
Drug Action:
Receptor = molecule or complex of molecules located on outside or inside of cell that has a
regulatory role in homeostatic control of organism. Normally bound to and activated by
endogenous ligands (substances ordinarily found in body). The location of receptor
determines where a drug will act and whether response from drug-receptor interaction is
beneficial or detrimental. (same receptors may be in different areas resulting in potential
adverse effects)
Agonists = drugs that bind to and stimulate receptor.
Antagonists = drugs that bind to but block the response at a receptor (does not have the same
compatibility of fit, does not activate receptor)
Pharmacology Exam
Module 1:
1. Discuss the influence of drug use by ancient civilizations on modern pharmacology
⟶ Ancient China (2700 B.C.)
• Drug Ma Huang treated coughs, influenza, and fevers
• Ephedrine was isolated from it to treat asthma, and its derivative used as a
decongestant
⟶ Ancient Egypt (1550 B.C.)
• Papyrus (documents) contained observations on use of drugs, particularly on
purgatives, used to cause bowel movements
• Recommended Senna to treat sue, that are still available today
Ancient Greece (380 B.C.)
Theophrastus, a pupil of Aristotle, wrote a textbook on therapeutics that included
opium.
Opium was found to contain 10% morphine, which is able to relieve pain of very
great intensity.
2. Describe the process of developing a new drug, the conduct of clinical trials, and the
techniques used in drug advertising
1. Drug discovery
⟶ Research and discovery of target – discovery of lead compounds
⟶ Preclinical testing – determine safety and potential
efficacy Two main categories of preclinical studies exist:
Toxicology studies – determine effect of new drug on organ systems other
than targeted organ (Adverse effects).
Pharmacology – determine detailed mechanism of action of new drug (how the
drug functions).
2. Clinical trials
⟶ Phase 1 – safety and potential efficacy
⟶ The absorption, distribution, elimination and adverse effects of the new drug are
carefully studied. Usually one or two doses of the new drug are administered, and
the tolerability of the drug is determined.
⟶ Phase 2 – safety and tolerability
Conducted in patients who have the disease for which the disease is designed to
treat. Determines the effectiveness of drug in treating condition it is
recommended for, in a limited number of people.
⟶ Phase 3 – effectiveness and safety
These trials, often called controlled randomized clinical trials, are one of the main
studies used for the licensing and marketing of the drug. These studies test the
drug in a larger number of people (usually one thousand or more) to obtain more
information on the safety and efficacy of the drug. Determine if drug is safe and
effective.
Parts of a phase 3 clinical trials:
,PHARM 100 Pharmacology_Exam. Module 1- Module 6
Target population = group of patients for whom drug is intended.
Inclusion/Exclusion criteria = patients selected from target population according
to strict set of inclusion and exclusion criteria to eliminate all variables other than
drug under study. Criteria must define characteristics of patients who are not
eligible to be part of trial (e.g. patients with multiple diseases could influence
results).
Ethical considerations and consent = Informed consent must be obtained before
participation in clinical trial. Purpose, procedure, potential risks, benefits must be
understood by patient. The trial methodology and informed consent documents
are reviewed by an independent Institutional Ethics Review Board to protect
rights of participants.
Study population randomized allocation = patients recruited for study are assigned
to experimental or control groups by chance, randomization. Patients with
different characteristics are equally distributed between treatment and control
groups, maximizing comparability of groups removing bias in assigning patients
to groups.
Treatment = patients in treatment group will receive experimental drug.
Control = experimental drug has to be compared to a control drug, either a
placebo or a gold standard drug depending on disease.
,PHARM 100 Pharmacology_Exam. Module 1- Module 6
Placebo = (inert substance masquerading as a drug) tablet that doesn’t contain any
active drug but is identical in appearance, colour, taste, size to tablet containing
active drug. People anticipate that drug will ease ailment, making it actually work
just because we believed it. (placebo response can be as high as 35%)
Gold standard drug = drug accepted by medical community as best treatment
available for disease at the time. It is unethical to not give this drug is available.
Blinded assessment = Neither investigator nor study subject is aware of
treatments study subject is assigned to, eliminating bias.
Outcome = results of treatments should be measured in objective and reliable
manner.
Compliance = For results to be valid, patient compliance must be determined.
Counting remaining tablets at each clinic visit measures overall compliance.
(compliance can be as low as 50-60-%)
Quality of life = measure impact of drug or treatment on quality of life of
participants.
Analysis of results = experimental drug results must be compared to control drug
results using statistics. Statistics can determine if difference between drugs is real.
Or by chance.
3. Health Canada/FDA approved Drug
⟶ Health Canada Review and Manufacturing – Drug approval and production
Health Canada review: After initial phase 3 trials, manufacturer will submit to
regulatory body a new drug application containing detailed results of clinical
trials. Results are reviewed by regulatory scientists. If drug is effective, toxicity
is acceptable, it is granted approval.
Manufacturing: Generic vs Brand name: Since drugs formal chemical name is too
complex for general use, generic name for drug is selected. Manufacturer will
apply for a patent with a brand name for drug, which will give company exclusive
rights to market drug for 20 years (starting from when patent is filed in preclinical
development phase so the effective patent life of a drug is in range of 10 to 12
years). After patent on a drug expires, other manufacturers can make copies of
original drug and sell it under their own brand name.
Bioavailability studies = New brand name drugs and generic drug will contain
identical active ingredient as original brand name drug, in same amount and
usually in same dosage form. Comparative bioavailability study is conducted to
compare blood levels after administration of both drugs to healthy volunteers to
ensure drugs are bioequivalent.
, PHARM 100 Pharmacology_Exam. Module 1- Module 6
⟶ Phase 4 – long-term safety, referred to as post-marketing surveillance
Risks that are delayed or less frequent may be missed in the phase 3 trial.
Surveillance of the effects of drugs are required after drug is released for general
use.
Drug advertising:
For every dollar spent on drugs in Canada, 25 cents go to promotion of drugs, nearly all of which
goes to enticing physicians to prescribe drugs. Persuasion is the main purpose of drug
advertisements so a major deficiency in drug advertising is the lack of information on the
adverse effects of the drug.
Advertising Techniques:
Techniques used to try to convince physicians and patients to adopt a specific drug.
1. Catch audience attention = ad designed in a way to draw eyes of audience.
2. Use of celebrities/authorities to endorse products = people often trust authorities or
admire celebrities, which can be exploited by drug ads.
3. Fear = tactic is to illicit fear in person, then provide a drug that will help abate that fear.
4. Offer an easy solution to problems = technique focuses on how easy it is to treat
disease with drug.
5. Before-after technique = ad has person in undesirable circumstance, then ad will have a
following picture of same person after taking drug who is now in desirable circumstance.
6. Discredit drugs produced by other manufacturers and praise your own = make new drug
look better than other drugs on market that treat same condition as new drug.
3. Explain how drugs act on the body to produce their effect, and explain why drug
variability exists
Drug Action:
Receptor = molecule or complex of molecules located on outside or inside of cell that has a
regulatory role in homeostatic control of organism. Normally bound to and activated by
endogenous ligands (substances ordinarily found in body). The location of receptor
determines where a drug will act and whether response from drug-receptor interaction is
beneficial or detrimental. (same receptors may be in different areas resulting in potential
adverse effects)
Agonists = drugs that bind to and stimulate receptor.
Antagonists = drugs that bind to but block the response at a receptor (does not have the same
compatibility of fit, does not activate receptor)
