Deck 2: Drug Design, Testing, Manufacturing, and Marketing

Question 1

The patent on a new drug is in effect for ________ years.

A) 5
B) 12
C) 17
D) 23

Answer 1

17

Question 2

In 1982,which drug became the first recombinant DNA technology drug to be approved by the FDA?

A) the semisynthetic penicillin known as ampicillin, which was fermented in vats
B) diazepam (Valium)
C) human insulin (Humulin)
D) Taxol (chemotherapy drug)

Answer 2

human insulin (Humulin)

Question 3

Once the FDA gives final approval for drug marketing,the drug company creates a ________.

A) chemical name
B) generic name
C) molecular name
D) trade name

Answer 3

trade name

Question 4

From the moment of its discovery or design,every drug has a ________ name that is assigned by the International Union of Pure and Applied Chemistry (IUPAC).

A) brand
B) chemical
C) generic
D) trade

Question 5

Inert ingredients in a drug ________.

A) include fillers to shape a tablet
B) can affect drug bioavailability
C) also include binders
D) all of the above

Question 6

Each drug is assigned a 10-digit code,broken up into three segments.Which of the following is NOT information that can be obtained from the 10-digit code?

A) the name of the drug company
B) the drug category
C) the drug's specific strength/dose
D) the package size and type

Question 7

The drug name that is a registered trademark is the ________.

A) generic name
B) chemical name
C) trade name
D) all of the above

Question 8

In vivo testing is ________.

A) testing that is done in test tubes
B) similar to in vitro testing
C) done prior to in vitro testing
D) none of the above

Question 9

The trade name of the drug Lithobid was selected to indicate ________.

A) the name of the drug company
B) how often the drug is to be given
C) the amount of the active ingredient
D) the disease the drug is used to treat

Question 10

Information from the human genome has led to the development of the subspecialty areas of ________ in research and drug design.

A) pharmacogenetics and pharmacogenomics
B) pharmacodynamics and pharmacology
C) recombinant DNA technology and computers
D) pharmacology and stem cell therapy

Question 11

All of the following are reasons why the trade names of some drugs are spelled in a certain way.Identify the reason that is NOT true.

A) The spelling of the trade name indicates the length of the drug's patent.
B) The spelling of the trade name indicates the drug's source.
C) The spelling of the trade name indicates the disease process being treated.
D) The spelling of the trade name indicates how often the drug should be taken.

Question 12

There are ________ phases of human testing for new drugs.

A) two
B) three
C) five
D) seven

Question 13

In clinical trials,the control group receives the ________.

A) trade name drug
B) placebo
C) chemical name drug
D) generic name drug

Question 14

In the distant past,without the use of computers,designing a new drug was ________.

A) a quick process, done by just repositioning molecules
B) a slow process of trial and error
C) not done, because drug companies didn't know about molecular structures
D) easy to do, by using models of wood and wire

Question 15

Which name accurately describes the molecular structure of a drug and distinguishes it from all other drugs?

A) brand name
B) chemical name
C) generic name
D) trade name

Question 16

Which of the following involves using a drug on several hundred or several thousand ill patients in exactly the same way as it will be used once it is on the market?

A) clinical trials, phase I
B) clinical trials, phase II
C) clinical trials, phase III
D) in vivo testing

Question 17

Using computers to design new drugs involves ________,which is the study of the chemical structures of drugs and their actions at the molecular level within a cell.

A) genetics
B) molecular pharmacology
C) pharmacodynamics
D) recombinant DNA technology

Question 18

Which of the following is registered with the U.S.Patent Office as a registered trademark?

A) chemical name
B) generic name
C) molecular structure
D) trade name

Question 19

Drugs can be created or designed using all of the following techniques,EXCEPT ________.

A) discovery in nature
B) observing the toxic effects
C) computer-aided design
D) recombinant DNA technology

Question 20

Recombinant DNA technology involves ________.

A) gene splicing
B) genetic engineering
C) human DNA spliced into a bacterial cell
D) all of the above

Question 21

All of these trade names reflect the disease that the drugs are used to treat,EXCEPT ________.

A) Sudafed
B) Pepcid
C) Azmacort
D) Rythmol

Question 22

Which of the following statements is FALSE?

A) There is only one generic drug name related to a specific chemical name.
B) The trade name is specifically designed to be easy for physicians and patients to remember.
C) The drug's original trade name can be used by other companies after the patent expires.
D) The spellings of generic drugs that belong to the same drug category often reflect their similar chemical structure.

Question 23

The United States Adopted Names (USAN)Council ________.

A) gives the final approval for marketing of a drug
B) works with the drug company to determine the generic name for a drug
C) selects the generic and trade names for all drugs
D) names all new chemical and molecular substances

Question 24

A dextrorotary drug ________.

A) is an isomer
B) has a right-facing image for its molecular structure
C) example is that of dextromethorphan
D) all of the above

Question 25

The FDA evaluates a drug before approving it.This evaluation includes a review of ________.

A) the drug company's documentation
B) consumer comments about the drug
C) drug's risks and benefits
D) A and C

Question 26

The first recombinant DNA technology drug approved by the FDA was ________.

A) an over-the-counter drug
B) a drug for HIV
C) a drug from pregnant mares' urine
D) human insulin

Question 27

Slight molecular changes to a drug can significantly affect its ________.

A) absorption and metabolism
B) half-life
C) Therapeutic effect and side effects
D) all of the above

Question 28

Using recombinant DNA technology,which substance has been made into a recombinant DNA technology drug?

A) clotting factors
B) erythropoietin
C) human growth factor
D) all of the above

Question 29

An example of a placebo is ________.

A) an injection of sterile normal saline
B) a genetically engineered drug
C) a sugar pill
D) A and C

Question 30

When designing drugs,a computer can ________.

A) display the molecular structure of any drug in its database
B) identify chemicals that would probably not be successful in treating a particular disease, which saves time and money
C) rotate any molecule in three dimensions on the computer screen
D) all of the above

Question 31

A moisture-absorbing packet of silica gel,known as ________,is something that would be added to a drug container to keep tablets from deteriorating.

A) the half-life
B) a placebo
C) an isomer
D) a desiccant

Question 32

All of the following are examples of new drugs discovered in the environment,EXCEPT ________.

A) a placebo used in double-blind studies
B) a chemotherapy drug derived from yew tree needles
C) cephalosporin antibiotic drugs from a fungus in a sewer outlet
D) an antituberculosis drug from the stomach of a sick chicken

Question 33

Why would a physician give a patient a free sample of a drug?

A) To give away what the drug representatives gave them
B) To help patients save money
C) To allow the patient to try a limited supply to see if it worked
D) To fulfill FDA requirements

Question 34

The chemical name of a drug ________.

A) is too lengthy and complicated for everyday use by healthcare professionals
B) is only used by researchers and consumers
C) is the same as the generic name of the drug
D) all of the above

Question 35

What can the FDA do when it receives reports of adverse drug effects for a particular drug?

A) The FDA can red flag a drug.
B) The FDA can have the drug company expand the warning label on the drug.
C) The FDA can withdraw the drug from the market.
D) B and C

Question 36

What incentive does the FDA give to drug companies that agree to do clinical trials of their drugs on children?

A) a cash-back refund
B) speeding up the process for getting a trademark for the drug
C) a six-month extension on the new drug patent
D) allowing the drug companies to market the drug to children

Question 37

Post-marketing surveillance ________.

A) is a type of direct-to-consumer advertising
B) is performed by the Federal Trade Commission
C) involves adding a National Drug Code to each drug package
D) is done by the drug company and the FDA to monitor drug safety

Question 38

What does the therapeutic index indicate?

A) the therapeutic potential for this new drug
B) the margin of safety between the therapeutic and toxic doses
C) the drug's effectiveness and likely approval by the FDA
D) the bioavailability of the drug

Question 39

The Human Genome Project ________.

A) led to the development of computer-aided design of drugs
B) mapped all 3.2 billion parts of the human genome
C) is the third part of clinical testing after in vivo testing
D) determined what the names of new genetic drugs should be

Question 40

This drug contains a double-strength dose,as shown by its trade name.

A) Bactrim DS
B) Kay Ciel
C) Pronestyl-SR
D) Tylenol w/ Codeine No. 2

Question 41

No matter how a drug was originally discovered or designed,it must be thoroughly tested by the FDA before it can be marketed.

Question 42

Once a drug has received its final approval from the FDA,its ingredients,doses,manufacturing process,labeling,and packaging cannot be changed.

Question 43

Many drugs still in use today were originally taken from plant,animal,or mineral sources hundreds or even thousands of years ago.

Question 44

The trade name K-Lyte/Cl tells us that this drug contains ________.

A) iron and glucose
B) potassium and chloride
C) a double strength dose of the drug
D) chloride and snail venom

Question 45

While it is physiologically impossible for a placebo to exert any pharmacological effect,patients often report a decrease in certain types of symptoms after taking a placebo.

Question 46

A drug tablet may include all of the following,EXCEPT ________.

A) binders and fillers
B) desiccant
C) preservatives
D) antioxidants and buffers

Question 47

The Recombinant DNA Advisory Committee is a group of physicians and pharmacists who review the clinical trials of genetically engineered new drugs and make recommendations to the FDA.

Question 48

The half-life of a drug can be increased because of ________.

A) liver or kidney disease
B) particulate matter
C) animal studies
D) the presence of desiccant

Question 49

The drug Byetta,which is used to treat diabetes mellitus,is derived from ________.

A) coal mining
B) saliva of the Gila monster
C) venom of the cone snail
D) recombinant DNA technology

Question 50

The pharmacodynamics of a drug are tested during the human phase of drug testing.

Question 51

An isomer is a drug that has the same chemical formula as another drug,but has those atoms arranged in a different way.

Question 52

Generic drugs and trade name drugs that are in the same drug form and drug strength--even if they are from different drug companies-must contain exactly the same amount of active ingredient.

Question 53

Pharmacokinetics involves ________.

A) absorption of a drug
B) distribution of a drug
C) metabolism of a drug
D) all of the above

Question 54

The advertising of both prescription and OTC drugs is regulated by the FDA.

Question 55

The animal phase of drug testing precedes testing on humans.

Question 56

The higher the number of the therapeutic index,the more desirable it is,because it indicates that the drug has a wide margin of safety.

Question 57

A drug company is protected by a 17-year patent on any new drug that is approved by the FDA.However,part of the 17-year patent period is used up during the testing process.

Question 58

The FDA has standards for the spelling of trade name drug,and drug companies must follow them.

Question 59

The first drug to be created with recombinant DNA technology was ________.

A) Humulin insulin
B) Allegra
C) rDNA
D) hydrochlorothiazide

Question 60

Once a drug has been approved by the FDA,the drug can continue to be marketed indefinitely because it has received FDA approval.

Question 61

There are three phases of human testing,which together are known as ________.

Question 62

The label of a drug does not need to contain an expiration date printed on it,because drugs never expire.

Question 63

Once phase III is completed,the drug company submits all of its documentation on the drug to the FDA in the form of a NDA.The abbreviation NDA stands for ________.

Question 64

A drug company may evaluate thousands of different chemicals before finding one that moves successfully through all phases of testing and is finally approved by the FDA for release and marketing.

Question 65

The ________ of the active drug ingredient can be particularly crucial in drugs with a low therapeutic index.

Question 66

Individual genes from DNA can be manipulated to create drugs.

Question 67

When animal studies are completed,the drug company submits an IND application to the FDA.The abbreviation IND stands for ________.

Question 68

A placebo uses the power of suggestion to produce changes in the body that mimic the pharmacologic action of an actual drug.

Question 69

In a double-blind study,every patient receives both the drug and a placebo.

Question 70

A drug can be approved to treat one thing and then,after further clinical trials,can also be approved to treat something completely different.

Question 71

MedWatch is the FDA safety information and adverse event reporting system on the Internet.

Question 72

Define these abbreviations.
FDA ________
DTC ________
TI ________
IND ________
NDC ________
rDNA ________

Question 73

The Human Genome Project allowed drug researchers to begin gene therapy to replace defective genes in the body.

Question 74

Drugs that are successfully tested in animals will always perform well when given to humans.

Question 75

DTC marketing has become common,beginning with magazine ads and moving to television.The abbreviation DTC stands for ________.

Question 76

Advertisements of drugs to consumers are heavily weighted toward prescription drugs for chronic diseases that require long-term treatment.

Question 77

It is not uncommon for a patient who is given a therapeutic dose of digoxin (Lanoxin)to exhibit symptoms of toxicity.

Question 78

In a double-blind study,the physician-investigator is the only one who knows which patients are taking a drug and which patients are taking a placebo.

Question 79

A ________,a drug that has no pharmacologic effect,is often used in double-blind studies during phase III clinical trials.

Question 80

The ending -olol is common to generic beta-blocker drugs.