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PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT ELABORATED TO SCORE A+ FOR SUCCESS||Latest Update 2024/2025$12.49
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PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT ELABORATED TO SCORE A+ FOR SUCCESS||Latest Update 2024/2025
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Course
Pharmacology
Institution
Pharmacology
PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT ELABORATED TO SCORE A+ FOR SUCCESS||Latest Update 2024/2025
PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND
ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT
ELABORATED TO SCORE A+ FOR SUCCESS
Bioequivalence Definition - CORRECT ANSWERS Pharmaceutical equivalents that
display the SAME RATE and EXTENT OF ABSORPTION
Means delivering the SAME AMOUNT of ACTIVE DRUG moiety to SITE OF ACTION when
GENERIC or INNOVATOR drugs are administered at the same molar dose under SIMILAR
CONDITIONS
Therapeutic Equivalents Definition - CORRECT ANSWERS Considered equivalent when
the GENERIC drugs are PHARMACEUTICAL EQUILVALENTS and show SAME EFFICACY,
SAFETY PROFILE as product whose efficacy and safety has been established
Pharmaceutical Equivalents Definition - CORRECT ANSWERS Considered equivalents
when BOTH AGENTS contain IDENTICAL AMOUNTS of ACTIVE ingredients in the same
SALT or ESTER form, ROUTE of administration and possess IDENTICAL disintegration
TIMES, and DISSOLUTION rates.
Clinical Judgement in Prescribing - 7 Characteristics - CORRECT ANSWERS 1. Clear
Indication for drug?
2. Drug effective in treating this disorder?
3. What are the goals of taking drug?
4. What conditions determine drug IS NOT meeting goal and different therapy should be
tried?
5. Duplications with other drugs patient already taking?
6. Would over-the-counter drug be as useful?
7. What about cost?
Pre-Clinical - Drug Development Phases: - CORRECT ANSWERS Studies in lab
(performed on cells, isolated tissues/organs, animals)
Designed to provide basic safety, bioavailability, pharmacokinetic, and initial efficacy
data
Development of suitable formulation for clinical use
Reproductive toxicology
,PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND
ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT
ELABORATED TO SCORE A+ FOR SUCCESS
Long-term carcinogenic testing
Phase I - Drug Development Phases: - CORRECT ANSWERS Healthy people - Volunteers:
used to establish:
1. Biological effects
2. Safe Doses and tolerability
3. Pharmacokinetics
4. Pharmacodynamic effect (B/P, HR, ECG)
Phase I Drug Development - How Stopped - CORRECT ANSWERS 1. Trial stopped if
half-life too short or too long
2. Trial stopped with significant ECG changes, severe adverse effects
3. Trials START with sub-pharmacological doses that are escalated following multiple
doses (if safe)
4. Pre-clinical data available
5. Costs: $500,000-1.5M / drug tested
Phase II - Drug Development Phases: - CORRECT ANSWERS 1. Used to treat disease in a
SMALL NUMBER of patients.
2. Establish the ability to IMPROVE patient outcomes
Test Efficacy and Safety
Phase IIa: Drug limited to single/maximal tolerated dose level. 10-100 patients
Phase IIb: Follows proof of concept (Phase IIa) - Several dose levels are tested on target
population (dose ranging studies)
How Progresses to Phase III - Drug Development - CORRECT ANSWERS Depends on:
1. Drug efficacy relative to competitors
2. Safety profile
3. Probability of technical success and regulatory success
,PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND
ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT
ELABORATED TO SCORE A+ FOR SUCCESS
4. Remaining patent life of drug
5. Costs to produce
6. Market share
7 Price
8. Reimbursement
Phase III -Drug Development Phases: - CORRECT ANSWERS Minimum of TWO trials;
several thousand patients
1. Compare new med to standard therapy
2. Larger number of patients studied in POPULATIONS across the country
3. New drugs have to AS GOOD or BETTER
Confirms clinical dose, frequency, and timing of administration
Designed to test the hypothesis of efficacy
Adverse Effects are collected to assess benefit-risk potential
Phase IV - After Market Drug Development - CORRECT ANSWERS 1. Data submitted to
regulatory agencies
2. New drug application takes ~15 months to review
3. Process is expedited for oncology and HIV
4. Begins with post-marketing or safety surveillance trials
5. Harmful effects are discovered that can lead to the withdrawal of the drug
Surveillance - FDA continues to monitor (broader population use)
American Physiological Society - CORRECT ANSWERS 1. Translational research =
transfers knowledge new/improved methods of preventing, diagnosing, or treating
disease. Creates hypothesis
, PHARMACOLOGY EXAM 1 STUDY SET (WEEKS 1 - 3) QUESTIONS AND
ANSWERS LATEST UPDATE 2023/2024 ALL ANSWERS 100% CORRECT
ELABORATED TO SCORE A+ FOR SUCCESS
2. Biomarkers = quantitative measures of biological effect; provide links between
mechanisms of action and clinical effectiveness
3. Measure changes in biomarkers in both preclinical models and the clinical indicative
of the activity of potentially new drug for treating indication
Orphan Drug Status - CORRECT ANSWERS 1. Pharmaceuticals to treat rare disease
2. Fast track application (orphan drug act)
3. Disease should affect < 200,000 people
4. Market exclusivity for 7 years
5. Direct guidance from FDA on design of clinical plan
6. Cost of developing not covered by expected sales
Drug Responses Graded Definition and Rationale for Grading - CORRECT ANSWERS 1.
Biological effects that can be measured CONTINUALLY up to MAXIMUM responding
capacity of the biological system
2. Most drug responses are [xx] (e.g. changes in B/P after drug given)
3. When [xx], responses are EASIER to MANAGE clinically
Quintal Drug Response - CORRECT ANSWERS 1. Effects are responses that MAY or MAY
NOT occur (e.g. seizures, pregnancy, rash, sleep, death, etc.)
2. Prediction of drug DOSES or BLOOD levels that PRODUCE [xx] responses are MORE
reliable at POPULATION level
ION Channel Receptor Definition - CORRECT ANSWERS 1. Transmits signals across the
cell membrane
2. Increase the flow of [xx] and ALTER the electrical potential or separation of charged
[xx] across the membrane
Types of ION Channel Receptors - CORRECT ANSWERS 1. Acetylcholine (Ach) —
(nicotinic) - 5 nicotinic sub-units that form [xx] channel
2. GABA (gamma-aminobutyric)
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