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NAPSRX PRACTICE QUESTIONS EXAM QUESTIONS WITH COMPLETE ASNWERS

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NAPSRX PRACTICE QUESTIONS EXAM QUESTIONS WITH COMPLETE ASNWERS Which area of R&D has seen the largest cost increases? clinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? 10-15 years Which of the following regulatory ...

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  • May 5, 2024
  • 19
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers
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NAPSRX PRACTICE QUESTIONS EXAM QUESTIONS WITH

COMPLETE ASNWERS


Which area of R&D has seen the largest cost increases?

clinical trials

On average, how long does a new drug take to be developed (from discovery of

initial compound to FDA approval)?

10-15 years

Which of the following regulatory agencies is industry-based (run mainly by the

companies themselves)?

Pharmaceutical Research and Manufacturers of America (PhRMA)

Which of the following factors has simplified the pharmaceutical R&D process?

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.

True

According to your manual, which type of system is the best way to deliver

healthcare?

a market-based system

How would increased pharmaceutical price controls impact the US healthcare

system?

,increased price controls would stifle innovation

Which of the following invests a greater percentage of sales in research than the

biotech sector?

none of these

What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology

Innovation Act?

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)?

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.

True

Toxicity information in preclinical studies provides confidence about a drugs

safety aspect.

True

Pharmacological studies using animals are regulated under Good Laboratory

Practice.

True

Why do drugs administered to patients only contain APIs?

they don't

Which of the following does not affect a drug's ability to permeate membranes?

the drug's vesicles

, Through which barriers can lipid-soluble drugs usually pass?

cell membranes

How are weak acid drugs generally absorbed by the stomach?

more quickly than weak basic drugs

Which of the following routes of administration do NOT completely bypass the

liver?

rectal administration

Why are intravenous drug dosages easier to control than drugs administered

transdermally?

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?

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"?

transdermal

Carcinogenicity studies are carried out to identify the tumor-causing potential of

a drug.

True

According to NIH ethical guidelines, which of the following is the most important

criteria in selecting subjects for clinical studies?

scientific objectives

Which statement about the IRB is incorrect?

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?

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