Exam (elaborations)
NAPSR Ch 1-4: Questions & Complete Answers (Graded A+)
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NAPSR Ch 1-4: Questions & Complete Answers (Graded A+)
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NAPSR Ch 1-4: Questions & Complete Answers (GradedA+)
FFDCA Right Ans - Federal Food, Drug, and Cosmetic Act
Pharmaceutical Right Ans - Medicines and vaccines for human and animal
use.
Diagnostic Right Ans - Equipment and supplies used in screening,
detecting, and monitoring disease.
Medical device Right Ans - Advanced instrumentation and equipment used
for medical therapy such as joint replacement, implantable defibrillators, and
pacemakers.
Medical supplies Right Ans - Commodity, high volume supplies such as
surgical gowns and gloves.
DME Right Ans - Reusable products for health related use in home, such as
walker, wheelchair, oxygen equipment, prosthetics, and hospital beds.
Research and development
R&D Right Ans - The engine of innovation, focused on discovering
promising new chemicals or molecules and transforming them into safe and
effective pharm products.
Manufacturing and operations Right Ans - This includes the supply chain,
manufacturing, trade, and distribution function oft eh business.
Marketing and sales Right Ans - Personnel in this category communicate
the benefits of the company's pharm products and create demand for those
products using promotional programs designed to influence physicians,
pharmacists, payers, consumers, and other stakeholders in the pharm
decision making process.
Approval letter Right Ans - Letters sent by the FDA to the applicant
indicating whether the new drug application (NDA) or abbreviated new drug
application (ANDA) for a product substantially meets the necessary
, requirements and whether or not the agency believes that it can approve the
application.....
Asymptomatic Right Ans - Without signs or symptoms
Blinded or masked study Right Ans - When the participant does not know if
they are part of a experimental or control group in a study.
Control group Right Ans - The standard in which an experimental
observation is evaluated.
Double blind study Right Ans - Neither the participant nor the study staff
know which participants are receiving the experimental treatment and which
patients are in the control group.
Edema Right Ans - Swelling
Fast track drugs Right Ans - Fast track approval is provided for drugs that
meet medical needs for patients with serious life threatening conditions.
Indication Right Ans - In terms of drug approval, the exact cause or
purpose for which the FDA has approved that a drug be prescribed.
Institutional review board
IRB Right Ans - A committee of physicians, statisticians, community
advocates, and others which ensure that a clinical trial is ethical and that the
rights of the study participants are protected.
Off label Right Ans - Usage of a medication for purposes other than the
specific ones appearing in the labeling.
Placebo Right Ans - An inactive pill, liquid, or powder that has mo
treatment value.
Placebo effect Right Ans - The effect produced due to the expectations of
the patients.
Study protocol Right Ans - The general design and operating features of a
trial
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