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NAPRX/CNPR TEST BANK QUESTIONS AND CORRECT ANSWERS RATED A+
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NAPRX/CNPR TEST BANK 2023-2024QUESTIONS AND CORRECT ANSWERS
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Office of inspector General (OIG) - ANSWER-an arm of the department of Health and
Human Services, which investigates regulatory infractions, provides compliance advice,
and brings enforcement actions
Federal Trade Commission (FTC) - ANSWER-Regulates general business practices to
protect consumers against anti-competitive behavior and misleading claims
Drug Enforcement Administration (DEA) - ANSWER-Regulates the distribution and use
of narcotics and other controlled substances
Antibodies - ANSWER-are proteins made by the body's immune system to bind and to
neutralize foreign invaders.
Monoclonal Antibodies - ANSWER-antibodies used against breast cancer and non-
Hodkin's lymphoma, are created in laboratories to target the immune system of patients
to specifically kill cancer cells
Passive Diffusion - ANSWER-Diffusion is the random movement of molecules in fluid.
Because of the lipid bilayer construction of the membrane, non-polar (lipid soluble)
molecules are able to diffuse and penetrate the cell membrane. Polar molecules,
however, cannot penetrate cell membrane readily via passive diffusion and rely on other
transport mechanisms.
Facilitated Diffusion - ANSWER-Polar drug molecules have been observed to cross cell
membranes. The transport mechanism is via carrier systems. Transmembrane carriers,
such as proteins, are similar to receptors and bind polar and non-polar drug molecules.
They facilitate the diffusion of drugs across the cell membrane. This diffusion is from a
region of high concentration to low concentration.
Active Transport - ANSWER-the mechanism requires energy to drive the transportation
of drugs against the concentration gradients, from low to high. The transportation rate is
dependent on the availability of carriers and energy supply via a number of biological
pathways.
Pinocytosis - ANSWER-involves the engulfing of fluids by a cell. The process
commences with the infolding of cell membrane around fluids containing the drug. The
membrane then fuses and forms a vesicle with fluid core. In this way, the drug is taken
into the cell interior within the vesicle.
,First Pass Metabolism - ANSWER-Drug absorbed through the gastrointestinal tract
pass into the hepatic portal vein, which drains into the liver. The liver metabolizes the
drug, which leads to reduction in the availability of the drug for interaction with receptors
Blood-brain barrier - ANSWER-Due to this, distribution of drugs to the brain tissue is
restricted for some types of drugs. The reason is that the brain has a sheath of
connective tissue cells, the astrocytes, surrounding it, forming a barrier to passive
diffusion for polar drugs. In addition, the endothelial cells of the brain capillaries are
joined more tightly together, curtailing further the diffusion of polar drugs to the brain.
Lipid soluble drugs can diffuse into the brain more readily and bring forth their effects
Placental barrier - ANSWER-this consists of several layers of cells between the
maternal and fetal circulatory systems. Diffusion of polar drugs is limited: However, lipid-
soluble drugs can pass through the barrier. Fetuses are rich in lipids and may form a
reservoir for sequestering lipid soluble drugs
Phase 1 - ANSWER-these biochemical metabolism reactions include oxidation,
reduction and hydrolysis, which transforms the drugs into metabolites. A family of
enzymes called cytochrome P-450 is responsible for these reactions.
Phase II - ANSWER-these biochemical metabolism reactions involve the addition or
conjugation of subgroups, such as -OH, -NH and -SH to the drug molecules. These
reactions give rise to more polar molecules, which are less lipid-soluble and are
excreted from the body
Expression of Clearance of a Drug - ANSWER-CL = Rate of drug elimination/Drug
concentration in the blood
Single dose - ANSWER-This type of toxicity testing is conducted for several purposed,
including the determination of repeated doses, identification of organ is subjected to
toxicity, and provision of data for starting doses in human clinical trials. Various
characteristic of the animals are monitored, including weights, clinical signs, organ
functions, biochemical parameters, and mortality. At the completion of the study,
animals are killed and autopsies are preformed to analyze the organs, especially the
targeted organ for the drug
Repeated Dose - ANSWER-In this type of toxicity study the aim is to evaluate the
longer-term effects of the drug in animals. Plasma drug concentrations are measured
and pharmacokinetics analyses are performed. Vital functions studied include
cardiovascular, respiratory and nervous systems. Animals are retained at the end of the
study to check toxicity recovery
Carcinogenicity - ANSWER-type of study that is carried out to identify the tumor-causing
potential of a drug.
,Reproductive toxicology - ANSWER-The aim of these studies is to assess the effect of
the potential drug on mammalian reproduction
MRSD - ANSWER-maximum recommended starting dose
NOAEL - ANSWER-no observed adverse effect level
HED - ANSWER-human equivalent dose
Drug sample - ANSWER-is a unit of drug which is not intended to be sold and is
intended to promote the sale of the drug product
Sampling - ANSWER-may be the single most important factor in a pharmaceutical rep's
success
Section 503 of the Federal Food, Drug and Cosmetic Act - ANSWER-this prohibits the
sale, purchase, offer to sell, purchase, or trade prescription drug samples and drug
coupons.
3 Methods of E-Sampling - ANSWER-1. physicians can order samples online, and
samples are delivered by mail to each physician's practice
2. Physicians can go online, print out sample vouchers or coupons, and then give them
to patients along with a prescription for the product indicated on the voucher or coupon.
The patient then presents both the prescription and the voucher or coupon to the
pharmacy to receive a smple or a discount on the prescription, respectively
3. Patients can go online and print their own sample voucher or coupon, ask their
physician for a prescription for the product indicated on the voucher or coupon, and fill it
at the pharmacy. This option is not available in most countries, where direct-to
consumer advertising of pharmaceuticals is often prohibited by law.
tips for incorporating e-sampling - ANSWER-- Educate your physician customers on e-
sampling
- Continue to unpack and put away samples
- Work with Retail pharmacists
- Helping to 'make do'
Genotoxicity - ANSWER-These studies are to determine if the drug compound can
induce mutations to genes
4 basic transport mechanisms - ANSWER-o Passive Diffusion
o Facilitated Diffusion
o Active transport
o Pinocytosis
Factors the distribution pattern depends on - ANSWER-distribution pattern depends on
a number of factors:
, o Vascular nature of the tissue
o Binding of the drug to protein molecules in blood plasma
o Diffusion of the drug
Routes of Excretion - ANSWER-o Kidneys
o Lungs
o Intestine and colon
o skin
Pharmaceuticals - ANSWER-Medicines and vaccines for human and animal use;
products may have a trademark (brand) name or be generic, and they may be
prescription or over-the counter
Diagnostic - ANSWER-Equipment and supplies used in screening, detecting, and
monitoring disease, can range from simple home testing kits to sophisticated diagnostic
imaging technologies
Medical Devices - ANSWER-Advanced instrumentation and appliances used for
medical therapy, such as joint replacements, implantable defibrillators, and
pacemakers; also, drug delivery devices such as syringes, infusion pumps, metered-
dose inhalers, and transdermal patches
Medical Supplies - ANSWER-Commodity, high-volume supplies used such as surgical
gowns and gloves
Durable Medical Equipment - ANSWER-Reusable products for health-related use in the
home, such as walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds
Medical Library - ANSWER-One of the oldest methods of acquiring medical information,
most hospitals or clinics will have a library where current information will be available
Medical Journals - ANSWER-These are considered good sources of information. They
provide current perspectives from leading experts on various disease states and
treatment options. Major and current studies will be published in the more reputable
ones
Specialists - ANSWER-They are usually involved in medical research. You will most
often find them at universities or medical schools but they may also be found in private
practice. They perform the testing and do the necessary research for new products.
Approvable letter - ANSWER-Letter's sent by the FDA to the applicant indicating
whether the application (NDA) or abbreviated application (ANDA) for a product
substantially meets the necessary requirements and whether or not the agency believes
that it can approve the application or abbreviated application if specific additional
information or material is submitted or specific conditions (for example, certain changes
in labeling) are agreed to by the applicant
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