Pharmacology Exam1 StudySet (Weeks1 - 3) Questions And Answers2024/2025All Answers Correct Verified Best Graded A+ For Success
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Course
Pharmacology
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Pharmacology
Pharmacology Exam1 StudySet (Weeks1 - 3) Questions And Answers2024/2025All Answers Correct Verified Best Graded A+ For SuccessPharmaceutical Equivalents Definition - CORRECT ANSWERSConsidered equivalents when BOTH AGENTS contain IDENTICALAMOUNTS of ACTIVE ingredients in the same SALT or ESTERform, ...
Pharmacology Exam 1 Study Set (Weeks
1 - 3) Questions And Answers 2024/2025
All Answers Correct Verified Best Graded
A+ For Success
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.
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
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,PHARMACEUTICAL EQUILVALENTS and show SAME EFFICACY,
SAFETY PROFILE as product whose efficacy and safety has been
established
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
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,Reproductive toxicology
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.
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, 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
4. Remaining patent life of drug
5. Costs to produce
6. Market share
7 Price
8. Reimbursement
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