[MT 6314] Unit 5: Drug Regulation and Development questions with correct answers
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Course
RN- Nursing
Institution
RN- Nursing
Drug Development is initiated by the discovery of what compound? Correct Answer-Lead
What is used to produce penicillin? Correct Answer-Fungi
After the animal testing, the drug may be used for clinical testing of human studies. What is the drug called during this phase? Correct Answer-Investi...
[MT 6314] Unit 5: Drug Regulation and Development
questions with correct answers
Drug Development is initiated by the discovery of what compound?
Correct Answer-Lead
What is used to produce penicillin? Correct Answer-Fungi
After the animal testing, the drug may be used for clinical testing of
human studies. What is the drug called during this phase? Correct
Answer-Investigational New Drug (IND)
How many phases does a clinical trial have? Correct Answer-4 Phases
What is Phase 1 of a Clinical Trial? Correct Answer-Targeting drug
safety in humans
In this phase of the clinical trial, the drug is tested for its
pharmacokinetics (absorption, distribution, metabolism, and
elimination)? Correct Answer-Phase 1
What kind of subjects are included in the Phase 1 of the Clinical Trial?
Correct Answer-Humans without diseases
(but sometimes, few subjects have the disease)
,What is Phase 2 of the Clinical Trial? Correct Answer-Targeting Drug
Efficacy
What phase of the Clinical Trial is described below:
There are hypertensive individuals, and the IND (anti-hypertensive drug)
will be tested out on them, looking if it would be able to lower the blood
pressure. Correct Answer-Phase 2
What are the subjects for Phase 2? Correct Answer-Diseased Individuals
What is the Phase 3 of the Clinical Trial? Correct Answer-Comparison
of Drug to the Standard Treatment
What phase of the Clinical Trial is described below:
In an anti-hypertensive drug, there is a drug that already exists. The IND
should now be compared to the standard of treatment. Correct Answer-
Phase 3
Refers to the procedure wherein the patient does not know what drug
they are taking, whether it is the standard treatment or the IND. Correct
Answer-Double Blind
, The outcome in Phase 3 should be the IND is _________________ or
________________. Correct Answer-at par with the standard treatment,
regarding its efficacy or it should be better than the standard treatment
True or False: There are cases that the IND is less effective than the
standard treatment; this cannot be used. Correct Answer-False
In the clinical phases, what are being addressed? Correct Answer-Drug
Safety
Drug Metabolism
True or False: Drug Safety extends to the post-marketing surveillance.
Correct Answer-True
True or False: After passing the 3 phases of clinical testing, the drug is
approved for Marketing. Correct Answer-True
If adverse effects [ex. Gastric irritation, Drowsiness] are detected, it
should be indicated in the product ____________ of the drug to guide
consumers on what to expect upon consumption. Correct Answer-insert
In this phase, we can catch some of the chronic toxicities especially
since clinical trials have limited time duration. Correct Answer-post-
marketing
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