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CORRECT ANSWERS
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The Pharmaceuticals for children Act (PCA) of 2002 - CORRECT ANSWER-The PCA offers a six
month patent extension to manufacturers who evaluate a drug already on the market for its
safety efficacy, and dosage in children.
The Pediatric Research Equity Act—(PREA) of 2003 - CORRECT ANSWER-The PREA was designed
to promote much needed research on drug efficacy and safety in children. The PREA gives the
FDA the power for the first time to require drug companies to conduct pediatric clinical trials on
new medications that might be used by children..
The FDA Amendments Act of 2007 - CORRECT ANSWER-The FDA has legal authority to require
post-marketing safety studies to order changes and a drugs label to include new safety
information, and to restrict distribution of a drug based on safety concerns. In addition the FDA
is required to establish an active post-marketing risk surveillance system mandated to include
25 million patients by July 2010, and 100 million by July 2012. The FDA now has the authority to
take action ( limit distribution of a drug) if post-marketing info. Shows a drug to be less safe than
previously understood.
The Family Smoking Prevention and Tobacco Control Act of 2009 - CORRECT ANSWER-Allows
the FDA to regulate cigarettes the single most dangerous product available to US consumers.
,Three distinct features to limit personal bias - CORRECT ANSWER-Use of controls,
randomization, and blinding.
Controls - CORRECT ANSWER-Subjects receiving either standard drug treatment or placebo.
They are are important b/c they help us determine if the new tx is more or less effective than
standard treatments, or at least if the new tx is better or worse than no tx at all.
Randomization - CORRECT ANSWER-Subjects are randomly assigned to either the control group
or the experimental group (ie. The group receiving the new drug). The purpose of
randomization is to prevent allocation of bias, which results when subjects in the experimental
group are different from those in the control group.
Blinded - CORRECT ANSWER-A study in which the people involved do not know to which group-
control or experimental- individual subjects have been randomized.
Absorption amount - CORRECT ANSWER-Helps determine how intense effects of the drug will
be.
Absorption in Elderly - CORRECT ANSWER-May be reduced d/t ↓ ph, delayed mobility and
emptying
Absorption Rate - CORRECT ANSWER-Determines how soon effects of the drug will begin
Factors affecting absorption - CORRECT ANSWER-Rate of dissolution, surface area, blood flow,
lipid solubility, pH partitioning.
Absorption - CORRECT ANSWER-The movement of a drug from its site of administration into the
blood
, Acetylcholine - CORRECT ANSWER-One of the many neurotransmitters in the autonomic
nervous system. It acts on both the peripheral nervous system and central nervous system, and
it is the only neurotransmitter used in the motor division of the somatic nervous system. It is
the principal neurotransmitter in the autonomic ganglia.
Acetylcholinesterase - CORRECT ANSWER-An enzyme that converts acetylcholine into the
inactive metabolites choline and acetate. It is abundant in the synaptic cleft and its role in
rapidly clearing free acetylcholine from the synapse is essential for proper muscle function.
Acid - CORRECT ANSWER-A compound that can give up a hydrogen ion (proton) which makes it
a proton donor in a reaction. Tend to ionize in basic (alkaline) media.
Activation - CORRECT ANSWER-Effect on the receptor function equivalent to that produced by
the natural neurotransmitter at a particular synapse
Active tubular secretion - CORRECT ANSWER-Active transport systems in the kidney tubules
pump drugs from the blood to the tubular urine.
Adolescents - CORRECT ANSWER-12-16 years
ADR in Elderly - CORRECT ANSWER-7 times more common than younger adults
Adverse Drug Reaction(ADR) - CORRECT ANSWER-Any noxious, unintended, and undesired
effect that occurs at normal drug doses.
Albumin - CORRECT ANSWER-The most important protein for drugs to bind to since it is too
large to leave the bloodstream. Only unbound drug molecules can leave the vascular system.
Binding to proteins is reversible, and drugs can compete for the limited binding sites available
and the