, NR565 Week 1 Study Outline
Many questions are written to assess your clinical application of the material from the
textbook, in real-world scenarios.
Chapter 2: Review of Basic Principles of Pharmacology
How new drugs are developed :
the early part of the drug development process is called the preclinical stage. Identification
of promising drugs and their testing in animals occur during this stage. Pharmaceutical
companies will identify a drug target, starting sometimes with ingredients isolated from a
plant (or organism in the case of antibiotics) with desirable medicinal properties, sometimes
with a molecular target identified in the body to produce the desired response, and
sometimes with a disease in need of treatment.
Preclinical studies are performed on cells, isolated tissues and organs, and in laboratory animals to
identify promising compounds.
During the clinical stage of new drug development, pharmaceutical companies must
establish the safety and effectiveness of new products in humans. Phase I clinical trials
typically establish biological effects as well as safe dosages and pharmacokinetics in a small
number of healthy patients. During phase II clinical trials, new drugs are used to treat
disease in a small number of patients and to establish the potential of the drug to improve
patient outcomes. If the drug still looks promising, phase III clinical trials will compare the
new medication to standard therapy in a larger number of patients studied by at sites across
the country. New drugs must be at least as good as, and it is hoped better than, other
available therapies. Throughout the process, pharmaceutical companies work with the FDA.
During clinical trials, only several thousand patients receive a new drug. During the post-
marketing period, a larger population of patients receives the drug, and sometimes much is
learned about additional adverse effects that occur infrequently with use of the drug.
Drug responses :
There are two basic types of drug responses: quantal and graded. These responses differ in
how they are measured and dictate dosing decisions to achieve the desired effect.
Graded responses are biological effects that can be measured continually up to the
maximum responding capacity of the biological system (Box 2-2). Most drug responses are
graded. For example, changes in blood pressure are measured in millimeters of mercury
(mm Hg), and patients may experience small or large changes in blood pressure following
treatment with drugs. Graded responses are easier to manage clinically because we can see
how each patient responds to a particular dose of medication and, if appropriate, alter the
dosage to achieve a greater or lesser response. So if a patient's blood pressure is too low or
too high when a particular blood pressure medication is administered, we can adjust the
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