Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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
Long-term carcinogenic testing
Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
,Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
,Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
, Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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
Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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
Long-term carcinogenic testing
Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
,Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
,Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
, Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and
Answers all Answers 100%Correctly/Verified Answers Brand New
2024/2025 RATED A+
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
Pharmacology Exam 1 Study Set (Weeks 1 - 3) 318Questions and Answers all Answers
100%Correctly/Verified Answers Brand New 2024/2025 RATED A+
