Answers 100% correct
.other Exclusivity - ANSWER-3 years for a change if criteria are met
.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.
.4 basic transport mechanisms - ANSWER-o Passive Diffusion
o Facilitated Diffusion
o Active transport
o Pinocytosis
,.A positive likelihood ratio - ANSWER-ratio that tells us the odds of disease if the
test result is positive.
LR+ = Sensitivity/(1- Specificity
.A.A. - ANSWER-Referring to medication dosage, means "of each"
.A.C. - ANSWER-Referring to medication dosage, means "before meals"
.AAHP (American Association of Health Plans) - ANSWER-the primary U.S.
association of health plans, which includes health maintenance organizations
(HMOs), preferred provider organizations (PPOs), other forms of managed care,
and utilization review organizations (UROs)
.absolute risk reduction - ANSWER-the absolute adverse event rate for placebos
minus the absolute adverse event rate for treated patients
.Absorption - ANSWER-the process by which a drug disintegrated in the stomach
as molecules travel across the epithelial cell membranes lining the stomach and
intestines, then reach the filtering system in the liver called the Portal System
before reaching the systemic circulation. When a drug is taken by mouth, it is
metabolized in the liver and converted from the parent drug into metabolites
for therapeutic activity or excretion before it reaches the systemic circulation.
The amount of drug reaching the systemic circulation is reduced by what is
known as the first pass effect, that is, some of the drug is metabolized by certain
enzymes in the liver and stomach, excreted, and never reaches the systemic
circulation. HT presence of food in the stomach, acidity level, the structure and
binding of the tablet or capsule and many other situations can influence this
,.Absorption - ANSWER-The process in which a medication is absorbed into the
bloodstream
.Absorption Rate - ANSWER-The rate at which a drug is taken into a person's
blood stream within a specified time period. These rates can very from person
to person, creating the challenge of refining a drug so that it is effective on
people with slow rates but not toxic to people with fast rates
.Abstract concept - ANSWER-the starting point for measurement, it is best
understood as a general idea in linguistic form that helps us describe reality
.Accelerated Approval - ANSWER-A specialized FDA mechanism implemented in
the early 1990s to speed approval of drugs that represent a major advance in
addressing serious or life threatening disease for which no effective alternative
treatments exist. The impetus was the demand for new AIDS therapies. Under
accelerated approval, the FDA accepts a surrogate endpoint as evidence of
effectiveness, and the requires post-marketing studies to confirm the drug's
benefits
.ACE (angiotensin converting enzymes) inhibitors - ANSWER-generally treat
heart failure and hypertension. They decrease blood pressure by blocking an
enzyme that converts angiotensin I to angiotensin II
.Ace Inhibitors - ANSWER-Angiotensin-converting enzyme inhibitors. A class of
drugs used to treat cardiovascular conditions such as hypertension and chronic
heart failure
.Action Letter - ANSWER-The FDA's official response to an NDA (also known as
an NDA action). The message may be an approval letter, approvable letter, or a
non-approval letter
, .Active Metabolite - ANSWER-A biological active product of a medication's
metabolism
.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.
.Acute - ANSWER-In terms of diseases or conditions, abrupt onset and short-
term (as opposed to chronic)
.Acute Illness - ANSWER-A condition or illness that only lasts for a short period
of time. Ex. Common cold
.AD.LIB. - ANSWER-Referring to medication dosage, means "freely"
.Additions - ANSWER-Situations where two or more medication are used
together and the clinical effect is equal to the sum of their individual effects
.Adherence - ANSWER-The proper use of a medication be a patient. Involves
taking the medication on the correct schedule outlines by a physician, and using
the proper technique
.Adjuvant - ANSWER-A substance that enhances the action of a drug or antigen.
This therapy is the use of a second form of treatment in addition to the primary
therapy, for example, having chemotherapy in addition to surgery or radiation
therapy