Drug Design, Testing, Manufacturing, and Marketing
Pharmacology l Chapter 2
Quiz Yourself
1. Chemical name, generic name, and trade or brand name.
2. True.
3. [Only need to name six.] Trade names are chosen (1) to indicate the disease process
being treated, (2) to indicate what part of the body is being treated, (3) to simplify
the generic name while still retaining its phonetic sound, (4) to indicate the drug’s
ingredients, (5) to indicate the action of the drug, (6) to indicate how often the drug
is to be taken, (7) to indicate the duration of the drug’s action, (8) to indicate the
strength of the drug, (9) to indicate the route of administration, and (10) to indicate
the amount of a particular ingredient, (11) to indicate the drug manufacturer.
4. [Only need to name four.] New drugs may be discovered or created (1) from
ancient sources in use for many years, (2) from a totally new chemical discovered in
the environment (plants, animals, ocean, soil), (3) from molecular manipulation of a
drug already in use, (4) from genetic manipulation and recombinant DNA
technology, (5) from stem cell therapy, (6) from gene therapy.
5. Recombinant DNA technology (rDNA) involves using enzymes in a test tube to cut
apart a segment of a DNA molecule from a human cell. Gene cloning allows the
production of a large supply of this DNA segment.
The DNA segments are then spliced together (recombined) with the DNA in a
bacterial cell. As the bacterium multiplies, it carries the new DNA within it as part of
the genetic makeup of all subsequent generations of bacteria. In huge vats, these
bacteria can produce unlimited quantities of the drug.
6. Tests performed in vitro are done in a test tube; tests performed in vivo are carried
out in animals or humans.
7. There are three phases of human testing of a drug. During phase I, about 10 to 100
healthy volunteers are used to study a safe dose range, evaluate side effects, and
establish a final, correct dose and study the pharmacokinetics of the drug
(movement of the drug through the body via the processes of absorption,
distribution, metabolism, and excretion). In phase II, the drug is given to about 50 to
500 patients who actually have the disease that the drug is intended to treat to
determine its therapeutic effect. During phase III, the drug is administered to several
hundred or several thousand ill patients in exactly the way (dose, route of
administration, frequency, etc.) in which it will be used once it is on the market. The
performance of the drug is compared with that of other drugs currently being used
to treat the same disease in order to evaluate its relative effectiveness. In addition,
double-blind studies with the drug and a placebo are performed, in which neither
the patients nor the physician-investigators know which patients are receiving the
drug and which patients (the control group) are receiving the placebo.
8. A computer can display the molecular structure of any drug from a listing of
thousands contained in its database. With only very slight molecular changes, the
original drug may be significantly changed in a variety of ways that influence the
absorption, metabolism, half-life, therapeutic effect, or side effects. The computer
can also identify those chemicals that would probably not be successful in treating
a particular disease before time and money are invested in extensive testing.
With computers, researchers can study any molecule, rotating it in three dimensions
on the computer screen. By analyzing the molecules, researchers can tell if
Drug Design, Testing, Manufacturing, and Marketing
Pharmacology l Chapter 2
that particular arrangement of atoms is the “key” that will open the “lock“—that is,
activate a particular receptor on the cell membrane. When a researcher wants to
know why different-looking drugs seem to produce a similar effect on the same
receptor, he/she can have the computer superimpose all of the drugs on the screen
to see how their atoms match up.
9. The inert ingredients in a drug can affect the disintegration, absorption, metabolism,
and excretion of a drug, and this affects the bioavailability of the drug.
10. Numerous television ads for prescription drugs have prompted consumers to
demand new drugs in place of older, less expensive, but equally effective drugs. In
television advertisements, the indications, side effects, and risks of the drug are
usually abbreviated.
11. A drug can be withdrawn from the market because of adverse drug effects,
Especially those that involve deaths. A drug can be recalled because (1) it does not
contain the correct amount of active ingredient, (2) it does not remain stable until its
expiration date, and (3) it is contaminated with particulate matter from the
manufacturing process.
Clinical Applications Questions
1.
a. Toprol XL
b. 100 mg
c. AstraZeneca Pharmaceutic
d. 00186
e. 1092
f. 30 (tabs)
2. This drug is created by recombinant DNA technology. The label says “rDNA origin.”