MODULE 5 PROBLEM SET_ ESSENTIAL BIOLOGY II WITH
LAB- CORRELL.
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,7/23/2020 Module 5 Problem Set: Essential Biology II with Lab- Correll
Module 5 Problem Set
Due No due date Points 5 Questions 31 Time Limit None
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LATEST Attempt 1 1,699 minutes 0 out of 5 *
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Submitted Jul 23 at 5:38pm
This attempt took 1,699 minutes.
Question 1 Not yet graded / 0 pts
What “drugs” are regulated by the FDA and subjected to the clinical trial
process? Which are not?
Your Answer:
While prescription drugs are regulated by the U.S. Food and Drug
Administration (FDA) and the trial process, over-the-counter drugs
(including dietary supplements), behavioral therapies, health-delivery
systems, and surgical techniques are not regulated in the same way and
therefore, are not included in the phases of a clinical trial.
Prescription drugs (traditional drug therapies) and biologics.
Herbals, OTC medications, dietary supplements, surgical
techniques, behavioral interventions are not.
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, 7/23/2020 Module 5 Problem Set: Essential Biology II with Lab- Correll
Question 2 Not yet graded / 0 pts
Approval of a drug is broken up into what three phases?
Your Answer:
The preclinical phase
clinical investigation phase
New Drug Approval ( NDA)
post-marketing phase
Preclinical Clinical (subphases, including post-marketing)
NDA
Question 3 Not yet graded / 0 pts
What is the preclinical phase, and how long does it last?
Your Answer:
The preclinical phase involves exhaustive laboratory work that lasts in the
range of 1-3 years (average time is 18 months). During this time, cells are
grown in culture, and the candidate drug is tested to look for potential
harms. Animal testing, although becoming less common, is also
conducted during this phase.
Laboratory phase; simply tells us if something should not be
used in a human. Lasts 1-3 years.
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