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PHCY 512 Questions with Correct Answers.
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PHCY 512 Questions with Correct Answers.
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PHCY 512 Questions with Correct AnswersHow do companies decide which diseases to pursue for new drugs?
Correct Answer-Determine disease and target you're going after
Target profile (what should drug look like and do?)
Define product characteristics (route of administration, efficacy/safety,
patient population, indication, frequency of dosing, etc.)
overarching goal of companies pursuing new drugs Correct Answer-
keep patient in mind
CDER Correct Answer-The Center for Drug Evaluation and Research
(CDER) is the center within FDA that regulates over-the-counter and
prescription drugs
Generic drugs and biological therapeutics
CBER Correct Answer-The Center for Biologics Evaluation and
Research (CBER) regulates biological products
Biological products include blood, vaccines, cell therapies, and gene
therapies
CDRH Correct Answer-Center for Devices and Radiological Health
(CDRH) regulates medical devices and safe radiation-emitting products
,Premarket Notification (PMN) (doesn't go through steps as typical drug
product goes through) also called a 510(k)
Amount of info presented to FDA depends on level of risk
Class I (lowest risk; enema kits and elastic bandages), Class II (powered
wheelchairs and some pregnancy test kits) and Class III (highest risk;
implantable pacemakers, radiation therapy units)
drug development timeline (steps_ Correct Answer-1. drug discovery
2. screening
3. pre-clinical testing
4. apply for IND
5. phase I clinical trials
6. phase II clinical trials
7. phase III clinical trials
8. apply for NDA
9. phase IV clinical trials and beyond
t/f phase IV clinical trials occur before drugs are marketed Correct
Answer-false - AFTER
drug discovery Correct Answer-identify target, develop compounds
drug screening Correct Answer-screen compounds, optimize lead
,pre-clinical testing Correct Answer-PK/PD studies, animal toxicity
drug is formulated and placed into a drug delivery device
phase I clinical trials Correct Answer-safety in HEALTHY volunteers,
dosage
20-80 patients
goal: determine what the drug's most frequent side effects are and, often,
how the drug is metabolized and excreted
phase II clinical trials Correct Answer-human efficacy/ effectiveness,
side effects (short-term) in people with disease
100s of patients
goal: whether drug works in people who have a certain disease or
condition; for controlled trials, patients receiving the drug are compared
with similar patients receiving a different tx - usually a placebo, or a
different drug; safety and side effects are also evaluated
phase III clinical trials Correct Answer-confirm effectiveness in
different population
, 1000s of patients
goal: gather more info about safety and effectiveness, study different
populations and different dosages, and uses the drug in combo with
other drugs
phase IV clinical trials and beyond Correct Answer-additional safety
testing, monitoring for rare adverse events
once FDA approves a drug, the post-marketing monitoring stage begins;
the sponsor (typically the manufacturer) is required to submit periodic
safety updates to the FDA
optimizing lead compounds Correct Answer-1. lead compounds from
discovery
2. medicinal chemistry
3. hypothesis, design molecules, and synthesize
4. biology (in vitro)
5. test hypothesis
6. DMPK (animal studies, drug metabolism, and PK)
7. drug candidate selected for testing
8. analyze/ rationale results
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