NAPSRx Practice Questions (Latest 2023-2024)
A++ Exam with All New Qs & As - Guaranteed Pass!
- Which area of R&D has seen the largest cost increases?
Answer: clinical trials
- On average, how long does a new drug take to be developed (from
discovery of initial compound to FDA approval)?
Answer: 10-15 years
- Which of the following regulatory agencies is industry-based
(run mainly by the companies themselves)?
Answer: Pharmaceutical Research and Manufacturers of America
(PhRMA)
- Which of the following factors has simplified the pharmaceutical
R&D process?
Answer: none of these
- The landmark FDA Modernization Act of 1997 was a major step
forward in enabling safe and effective new drugs and biologics to be made available sooner to patients.
Answer: True
- According to your manual, which type of system is the best way
to deliver healthcare?
Answer: a market-based system
- How would increased pharmaceutical price controls impact the
US health- care system?
Answer: increased price controls would stifle innovation
- Which of the following invests a greater percentage of sales in
research than the biotech sector?
Answer: none of these
- / 3
- What was the intent of the Bayh-Dohl Act and the Stevenson-
Wydler Technology Innovation Act?
Answer: to hasten the commercialization of technologies that
otherwise might not be used
- According to your manual, what did the G10 Medicines Group
recently report about the pharmaceutical industry in the European Union (EU)?
Answer: there is poor collaboration between publicly- and
privately-funded research centers
- The aim of preclinical pharmacological studies is to obtain data
on the safety and effectiveness of the lead compound.
Answer: True
- Toxicity information in preclinical studies provides confidence
about a drugs safety aspect.
Answer: True
- Pharmacological studies using animals are regulated under
Good Labo ratory Practice.
Answer: True
- Why do drugs administered to patients only contain APIs?
Answer: they don't
- Which of the following does not affect a drug's ability to
permeate mem- branes?
Answer: the drug's vesicles
- Through which barriers can lipid-soluble drugs usually pass?
Answer: cell mem- branes
- How are weak acid drugs generally absorbed by the stomach?
Answer: more quickly than weak basic drugs
- Which of the following routes of administration do NOT
completely by- pass the liver?
Answer: rectal administration 2 / 3
- Why are intravenous drug dosages easier to control than drugs
admin istered transdermally?
Answer: The entire dose is available in the bloodstream to be
delivered to the target site
- Which of the following do not affect a drug's distribution to its
target tissues?
Answer: all of these affect a drug's distribution to its target tissues
- Which of these medical terms means "to apply the drug on the
skin's surface"?
Answer: transdermal
- Carcinogenicity studies are carried out to identify the tumor-
causing potential of a drug.
Answer: True
- According to NIH ethical guidelines, which of the following is
the most important criteria in selecting subjects for clinical studies?
Answer: scientific objectives
- Which statement about the IRB is incorrect?
Answer: The members of the IRB/IEC must be experts in the topic
of the study
- Which phases of clinical studies are open label and which are
blinded?
Answer: - Phase I and IV are often open label, Phase II and III are
double-blinded or at least blinded
- If it is not possible to measure the direct effects of a drug, what
is used instead?
Answer: surrogate markers such as blood pressure and cholesterol
levels
- Which of the following is an observational study that first
- / 3
identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (via chart reviews) to find exposure to risk factors?