EXAM 2025 TO 2026 COMPLETE STUDY
GUIDE PRACTICE QUESTIONS INDUSTRY
REVIEW AND EXAM PREPARATION
Medical Journals -CORRECT ANSWER-Medical journals 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 more reputable journals. In addition,
you may find ads for new and soon to be released products.
Specialist -CORRECT ANSWER-Researchers are usually found at
universities and medical schools, but also in private practice. They perform
the testing and do the necessary research for new products.
Research & Development -CORRECT ANSWER-The "engine of
innovation", focused on discovering - or inventing - promising new
chemicals or molecules and transforming them into safe and effective
pharmaceutical products.
Manufacturing & Operations -CORRECT ANSWER-This includes the
supply chain, manufacturing, trade, and distribution functions of he
business. Personnel in this category produce and package the drug product
and make it available in markets all over the world.
Marketing & Sales -CORRECT ANSWER-Personnel in this category
communicate the benefits of the company's pharmaceutical products and
create demand for those products using promotional programs designed to
,influence physicians, pharmacists, payers, consumers, and other
stakeholders in the pharmaceutical decision-making process. Also, in the
U.S., a special Managed Markets group is responsible for outreach to large
corporate accounts and managed care organizations.
Approvable Letter -CORRECT ANSWER-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 or abbreviated application if specific additional
information or material is submitted or specific conditions (e.g., certain
changes in labeling) are agreed to by the applicant.
Asymptomatic -CORRECT ANSWER-Without signs or symptoms of
disease
Blinded or masked study -CORRECT ANSWER-A study in which
participants do not know whether they are in the experimental or control
group in a research study. Those in the experimental group get the
medications or treatments being tested, while those in the control group get
standard treatment or no treatment.
Control or control group -CORRECT ANSWER-The standard by which
experimental observations are evaluated. In many clinical trials, one group
of patients will be given an experimental drug or treatment, while the
control group is given either a standard treatment for the illness or a
placebo.
Double-blind or double masked study -CORRECT ANSWER-Neither
participants nor the study staff know which participants are receiving the
experimental treatment and which patients are in the control group. These
,studies are performed so that neither patient nor doctor expectations about
the experimental drug can influence the outcome.
Edema -CORRECT ANSWER-Swelling
Fast-track drugs -CORRECT ANSWER-Fast track approval is provided
for drugs that meet medical needs for patients with serious or life-
threatening conditions.
Indication -CORRECT ANSWER-In terms of drug approval, the exact
cause or purpose for which the FDA has approved that a drug can be
prescribed.
Institutional review board (IRB) -CORRECT ANSWER-A committee of
physicians, statisticians, community advocates, and other which ensures
that a clinical trial is ethical and that the rights of the study participants are
protected. All clinical trials in the U.S. must be approved by an IRB before
they begin.
Off label -CORRECT ANSWER-Usage of a medication for purposes other
than the specific ones appearing in the labeling.
Placebo -CORRECT ANSWER-A placebo is an inactive pill, liquid, or
powder that has no treatment value. In clinical trials, experimental
treatments are often compared with placebos to access the treatment's
effectiveness.
Placebo effect -CORRECT ANSWER-The effect produced by a placebo
due to the expectations of the patient. The effect in placebo-controlled
, clinical trials is generally measured by comparing of the effect observed in
patients receiving the placebo treatment to the effect observed in patients
receiving the active treatment.
Study protocol -CORRECT ANSWER-The general design and operating
features of a trial. It is distinguished from the study manual of operations
by its generality and absence of specific details needed for day-to-day
execution of the trial.
Toxicity -CORRECT ANSWER-The extent, quality, or degree to which a
substance is poisonous or harmful to the body.
Treatment group -CORRECT ANSWER-A group of patients assigned to
receive a specified treatment.
Anatomy -CORRECT ANSWER-The study of the basic structures of the
body.
Physiology -CORRECT ANSWER-The study of how those body
structures function.
Clinical pharmacology -CORRECT ANSWER-The study of the effects and
movement of drugs in the human body.
Pharmacodynamics -CORRECT ANSWER-Study of the biochemical and
physiological effects of drugs and their mechanisms of action, i.e., the study
of what a drug does to the body.