Preview Extract
Chapter 2: Drug Design, Testing, Manufacturing, and Marketing Multiple Choice Questions 1. Stem cells are cells that are capable of ______. a. creating a cell with stems from which new cells can grow b. developing into immature cells c. differentiating into any type of body tissue d. manufacturing vectors that carry genes into affected cells Answer: c. differentiating into any type of body tissue Correct Feedback: Stem cells are immature cells that are capable of differentiating into any type of body tissue. a. creating a cell with stems from which new cells can grow Incorrect Feedback: Stem cells do not create cells with stems. b. developing into immature cells Incorrect Feedback: Stem cells already are immature cells. d. manufacturing vectors that carry genes into affected cells Incorrect Feedback: The use of vectors is related to gene therapy, not stem cells. 2. Which drug name accurately describes its molecular structure and distinguishes it from all other drugs? a. brand name b. chemical name c. generic name d. trade name Answer: b. chemical name Correct Feedback: The chemical name of a drug accurately describes its molecular structure and is commonly used by drug companies and researchers, but is too lengthy and complicated for everyday use by health professionals. a. brand name Incorrect Feedback: The brand name, or trade name, is specifically designed to be easy for physicians and patients to remember, not to describe its molecular structure. c. generic name Incorrect Feedback: Each drug has a generic name, but it does not describe its molecular structure. d. trade name Incorrect Feedback: The trade name does not describe the drug’s molecular structure. 3. In the past, without the use of computers, designing a new drug by changing the molecular structure of an existing drug was _____. a. a quick process of reassigning molecules b. a slow process of trial and error c. nonexistent as physicians didn’t know about chemical structures d. the only way new drugs could be created because drug manufacturers had exhausted other avenues Answer: b. a slow process of trial and error Correct Feedback: In the distant past, designing a new drug by changing the molecular structure of an existing drug was a slow process of trial and error, using intuition and molecular models made from wood and wire. a. a quick process of reassigning molecules Incorrect Feedback: Without the use of computers, designing drugs was not quick. c. nonexistent as physicians didn’t know about chemical structures Incorrect Feedback: Even before computers, physicians did know about chemical structures. d. the only way new drugs could be created because drug manufacturers had exhausted other avenues Incorrect Feedback: There was only one way that was known. 4. 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 pharmacology Answer: b. molecular pharmacology Correct Feedback: Using computers to manipulate chemicals at the molecular level and design new drugs involves molecular pharmacology, the study of the chemical structures of drugs and their actions at the molecular level within a cell and even the DNA within the molecules. a. genetics Incorrect Feedback: Genetics is the basis for gene therapy and designing new drugs. c. pharmacodynamics Incorrect Feedback: Pharmacodynamics is the mechanism of action by which drugs produce their effects (desired or undesired) based on time and dose. It does not involve computers. d. recombinant pharmacology Incorrect Feedback: Recombinant DNA technology uses enzymes in test tubes, not computers, to splice DNA and direct the production of particular drugs. 5. 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: c. human insulin (Humulin) Correct Feedback: In 1982, human insulin (Humulin) 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 Incorrect Feedback: Penicillin and ampicillin were not created using recombinant DNA technology. b. diazepam (Valium) Incorrect Feedback: Diazepam (Valium) was created from chlordiazepoxide (Librium), but not by recombinant DNA technology. d. Taxol (chemotherapy drug) Incorrect Feedback: Taxol was originally derived from the needles of the Pacific yew tree, not from recombinant DNA technology. 6. 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 Answer: a. pharmacogenetics and pharmacogenomics Correct Feedback: Information from the human genome has led to the development of the subspecialty areas of pharmacogenetics and pharmacogenomics in research and drug design. b. pharmacodynamics and pharmacology Incorrect Feedback: Information on the human genome has led to the development of pharmacodynamics but has not led to the general field of pharmacology. c. recombinant DNA technology and computers Incorrect Feedback: Information on the human genome has not led to the development of either recombinant DNA technology or computers. d. pharmacology and stem cell therapy Incorrect Feedback: Information on the human genome has not led to the development of pharmacology or stem cell therapy. 7. 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 Answer: b. chemical Correct Feedback: From the moment of its discovery or design, every drug has a chemical name that is assigned by the International Union of Pure and Applied Chemistry (IUPAC0). a. brand Incorrect Feedback: The brand name, or trade name, is created by the drug company, not the IUPAC. c. generic Incorrect Feedback: The drug company, working together with the United States Adopted Names (USAN) Council, not the IUPAC, determines a drug’s generic name. d. trader Incorrect Feedback: The trade name, or brand name, is created by the drug company, not the IUPAC. 8. 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 Answer: d. trade name Correct Feedback: The trade name of a drug is registered with the U.S. Patent Office as a registered trademark. a. chemical name Incorrect Feedback: A drug’s chemical name is assigned by the IUPAC, not the U.S. Patent Office. b. generic name Incorrect Feedback: The drug company, working together with the United States Adopted Names (USAN) Council, not the U.S. Patent Office, determines a drug’s generic name. c. molecular structurer Incorrect Feedback: A drug’s molecular structure is part of the drug’s makeup, and is not registered as a trademark. 9. In 2001, the first embryonic stem cell was manipulated to become a _____. a. bone marrow cell b. cell to treat Alzheimer’s disease c. mature blood cell d. retinal cell Answer: c. mature blood cell Correct Feedback: In 2001, the first embryonic stem cell was manipulated to become a mature blood cell. a. bone marrow cell Incorrect Feedback: Stem cell therapy has been used to replenish bone marrow, but bone marrow was not the first embryonic stem cell manipulation. b. cell to treat Alzheimer’s disease Incorrect Feedback: Alzheimer’s is one of the diseases that researchers hope to cure in the future using stem cell research. d. retinal cell Incorrect Feedback: The world’s first gene therapy, not stem cell therapy, was used to correct an inherited disorder of the retina in 2007. 10. 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 Answer: c. clinical trials, phase III Correct Feedback: During phase III, the drug is administered to several hundred or several thousand ill patients in exactly the same way (dosage, route of administration, frequency, etc.) it will be used once it is on the market. a. clinical trials, phase I Incorrect Feedback: During phase I, about 10 to 100 healthy volunteers are used to study a drug. b. clinical trials, phase II Incorrect Feedback: 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. d. in vivo testing Incorrect Feedback: In vivo testing is a general designation for any testing done on animals and humans. 11. 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 type c. the drug’s specific strength/dose d. the package size and type Answer: b. the drug type Correct Feedback: The 10-digit code, given in three segments, identifies the drug company (first segment), the drug’s specific strength/dose (second segment), and the package size and type (third segment). a. the name of the drug company Incorrect Feedback: The first segment of the 10-digit code does identify the drug company. c. the drug’s specific strength/dose Incorrect Feedback: The second segment of the 10-digit code does identify the drug’s specific strength/dose. d. the package size and type Incorrect Feedback: The third segment of the 10-digit code does identify the drug’s package size and type. 12. 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: d. trade name Correct Feedback: Once the FDA gives final approval for drug marketing, the drug company creates a trade name or brand name. a. chemical name Incorrect Feedback: The chemical name is assigned by the IUPAC, not the drug company. b. generic name Incorrect Feedback: The generic name is developed by both the drug company and the U.S. Adopted Names Council before the FDA gives final approval for marketing. c. molecular name Incorrect Feedback: A drug does not have a molecular name, but uses a chemical name instead to describe the drug’s molecular composition. 13. The drug name that is a registered trademark is the _____. a. generic name b. chemical name c. brand name d. all of the above Answer: c. brand name Correct Feedback: The brand name or trade name of a drug is registered with the U.S. Patent Office as a registered trademark. a. generic name Incorrect Feedback: The generic name is not a registered trademark. b. chemical name Incorrect Feedback: The chemical name is not a registered trademark. d. all of the above Incorrect Feedback: Only one of the answers is correct. 14. All of the following are reasons why a trade name drug is spelled 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 it is used to treat. d. The spelling of the trade name indicates how often the drug should be taken. Answer: a. The spelling of the trade name indicates the length of the drug’s patent. Correct Feedback: The spelling of a trade name never indicates the length of the drug’s patent. Tip 5: The drug manufacturer selects a trade name that indicates the ingredients or source of the drug. Tip 2: The drug manufacturer selects a trade name that indicates what disease condition or symptom the drug is being used to treat. Tip 7: The drug manufacturer selects a trade name that indicates how often the drug is to be taken. b. The spelling of the trade name indicates the drug’s source. Incorrect Feedback: The spelling of some trade names does indicate the drug’s source. c. The spelling of the trade name indicates the disease process it is used to treat. Incorrect feedback: The spelling of some trade names does indicate the disease process the drug is used to treat. d. The spelling of the trade name indicates how often the drug should be taken. Incorrect feedback: The spelling of some trade names does indicate how often the drug should be taken. 15. The brand name of the drug Lithobid was selected to indicate _______. a. the name of the drug manufacturer 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 Answer: b. how often the drug is to be given Correct Feedback: Tip 7: The drug manufacturer selects a trade name that indicates how often the drug is to be taken. Lithobid: Lithium drug given twice a day (b.i.d. is a Latin abbreviation that means twice a day). a. the name of the drug manufacturer Incorrect Feedback: The name Lithobid does not indicate the name of the drug manufacturer. c. the amount of the active ingredient Incorrect Feedback: The name Lithobid does not indicate the amount of the active ingredient d. the disease the drug is used to treat Incorrect Feedback: The name Lithobid does not indicate the disease the drug is used to treat. 16. 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 Answer: b. observing the toxic effects Correct Feedback: Toxic side effects are observed during animal testing. It is not a way in which drugs are created or designed. a. discovery in nature Incorrect Feedback: Drugs are created by discovery in nature. c. computer-aided design Incorrect Feedback: Drugs are created by computer-aided design. d. recombinant DNA technology Incorrect Feedback: Drugs are created by recombinant DNA technology. 17. In clinical trials, the control group receives the _____. a. trade name drug b. placebo c. chemical name drug d. generic name drug Answer: b. placebo Correct Feedback: 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. a. trade name drug Incorrect Feedback: The control group does not receive the trade name drug. c. chemical name drug Incorrect Feedback: The control group does not receive the chemical name drug. d. generic name drug Incorrect Feedback: The control group does not receive the generic name drug. 18. The patent on a new drug is in effect for ____ years. a. 5 b. 12 c. 17 d. 23 Answer: c. 17 Correct Feedback: A drug company is protected by a 17-year patent on any new drug that is approved by the FDA. a. 5 Incorrect Feedback: A drug patent is not in effect for five years. b. 12 Incorrect Feedback: A drug patent is not in effect for 12 years. d. 23 Incorrect Feedback: A drug patent is not in effect for 23 years. 19. There are _____ phases of human testing for new drugs. a. two b. three c. five d. seven Answer: b. three Correct Feedback: There are three phases of human testing, which are known as clinical trials. a. two Incorrect Feedback: There are more than two phases to human testing. c. five Incorrect Feedback: There are fewer than five phases to human testing. d. seven Incorrect Feedback: There are fewer than seven phases to human testing. 20. Recombinant DNA technology involves _____. a. gene splicing b. genetic engineering c. DNA spliced into a bacterial cell d. all of the above Answer: d. all of the above Correct Feedback: Recombinant DNA technology (rDNA) is also known as gene splicing or genetic engineering. The DNA segments are then spliced together (recombined) with the DNA in a bacterial cell. a. gene splicing Incorrect Feedback: This is true, but it is not the only correct answer. b. genetic engineering Incorrect Feedback: This is true, but it is not the only correct answer. c. DNA spliced into a bacterial cell Incorrect Feedback: This is true, but it is not the only correct answer. 21. In vivo testing is _____. a. testing is done in test tubes b. similar to in vitro testing c. done prior to in vitro testing d. None of the above Answer: d. None of the above Correct Feedback: Chemical analysis of a drug done in a laboratory in test tubes is known as in vitro testing (in vitro is Latin for in glass). Testing carried out in animals or humans is known as in vivo testing (in vivo is Latin for in living). a. testing is done in test tubes Incorrect Feedback: In vivo testing is not done in test tubes. b. similar to in vitro testing Incorrect Feedback: In vivo testing is not similar to in vitro testing. c. done prior to in vitro testing Incorrect Feedback: In vivo testing is not done prior to in vitro testing. 22. Inert ingredients in a drug _____. a. are known as fillers b. can affect drug bioavailability c. are known as binders d. all of the above Answer: d. all of the above Correct Feedback: Drug companies use different types of inert ingredients (binders, fillers), as well as different preservatives, antioxidants, and buffers in a drug that can affect the bioavailability. a. are known as fillers Incorrect Feedback: This is true, but it is not the only correct answer. b. can affect drug bioavailability Incorrect Feedback: This is true, but it is not the only correct answer. c. are known as binders Incorrect Feedback: This is true, but it is not the only correct answer. 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 Answer: b. works with the drug company to determine the generic name for a drug Correct Feedback: The drug company, together with an organization known as the United States Adopted Names (USAN) Council, determines a second name for the drug—its generic name. a. gives the final approval for marketing of a drug Incorrect Feedback: The FDA, not the USAN, gives final approval for marketing of a drug. c. selects the generic and trade names for all drugs Incorrect Feedback: The USAN does not select the trade names for drugs. d. names all new chemical and molecular substances Incorrect Feedback: The International Union of Pure and Applied Chemistry (IUPAC), not the USAN, assigns the chemical name. 24. 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. Answer: c. The drug’s original trade name can be used by other companies after the patent expires. Correct Feedback: The drug’s original trade name can only be used by the original drug company. It cannot be used by other drug companies, even after the patent expires. When the patent expires, any other drug company can manufacture that drug under its original generic name or under a new trade name. a. There is only one generic drug name related to a specific chemical name. Incorrect Feedback: This statement is true. b. The trade name is specifically designed to be easy for physicians and patients to remember. Incorrect Feedback: This statement is true. d. The spellings of generic drugs that belong to the same drug category often reflect their similar chemical structure. Incorrect Feedback: This statement is true. 25. 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 Answer: b. the margin of safety between the therapeutic and toxic doses Correct Feedback: The therapeutic index (TI) indicates the relative margin of safety between the dose that produces a therapeutic effect and the dose that produces a lethal effect in animals. a. the therapeutic potential for this new drug Incorrect Feedback: The therapeutic potential for the drug is evaluated by the drug company and the FDA and is not related to the therapeutic index. c. the drug’s effectiveness and likely approval by the FDA Incorrect Feedback: The therapeutic index relates to the drug’s margin of safety, not whether the drug will be effective and approved. d. the bioavailability of the drug Incorrect Feedback: The therapeutic index relates to the drug’s margin of safety, not its bioavailability. 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. a human version of insulin Answer: d. a human version of insulin Correct Feedback: In 1982, human insulin (Humulin) became the first recombinant DNA technology drug to be approved by the FDA. a. an over-the-counter drug Incorrect Feedback: Recombinant DNA technology is not used to produce overthe-counter drugs. b. a drug for HIV Incorrect Feedback: The first drug for HIV was AZT, but it was not produced by recombinant DNA technology. c. a drug from pregnant mares’ urine Incorrect Feedback: The drug from pregnant mares’ urine, a natural source (not recombinant DNA technology), is Premarin. 27. 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 Answer: a. Bactrim DS Correct Feedback: Tip 9: The drug manufacturer selects a trade name that indicates the strength of the drug. Bactrim DS is a double-strength dose of the antibiotic drug. b. Kay Ciel Incorrect Feedback: This trade name indicates the ingredients in the drug— potassium (K) and chloride (Cl). c. Pronestyl-SR Incorrect Feedback: This trade name indicates that this is a sustained-release drug (SR). d. Tylenol w/ Codeine No. 2 Incorrect Feedback: This trade name indicates the amount of a particular active ingredient (codeine). 28. Both the ethical and the tissue rejection issues of stem cell therapy can be avoided if _____. a. embryonic stem cells are used b. umbilical cord blood is used c. the patient’s own bone marrow or blood is used d. all of the above Answer: c. the patient’s own bone marrow or blood is used Correct Feedback: In 2001, the first embryonic stem cell was manipulated to become a mature red blood cell. This breakthrough ignited a controversy over the use of human embryonic cells in stem cell research. Umbilical cord blood can also be used for stem cell therapy, but only if the umbilical cord is saved and preserved after birth. Now, it is known that stem cells can be harvested from the patient’s own bone marrow or blood. This approach has no ethical concerns; it also involves no chance of tissue rejection because the stems cells are harvested from the patient. a. embryonic stem cells are used Incorrect Feedback: The use of embryonic stem cells to make a mature red blood cell ignited an ethical controversy. b. umbilical cord blood is used Incorrect Feedback: Any source of cells that does not belong to the patient raise the issue of tissue rejection. d. all of the above Incorrect Feedback: Not all of these are true. 29. 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. was a result of stem cell therapy d. determined what the names of new genetic drugs should be Answer: b. mapped all 3.2 billion parts of the human genome Correct Feedback: When the Human Genome Project was completed in 2000, the map of all 3.2 billions parts of the human genome had been deciphered. a. led to the development of computer-aided design of drugs Incorrect Feedback: Computer-aided design of drugs was in use before the Human Genome Project was undertaken. c. was a result of stem cell therapy Incorrect Feedback: The Human Genome Project was not a result of stem cell therapy. d. determined what the names of new genetic drugs should be Incorrect Feedback: The Human Genome Project is not related to the naming of drugs. 30. 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 Answer: a. is too lengthy and complicated for everyday use by healthcare professionals Correct Feedback: The chemical name is commonly used by drug companies and researchers, but is too lengthy and complicated for everyday use by healthcare professionals. b. is only used by researchers and consumers Incorrect Feedback: The chemical name is only used by drug companies and researchers. c. is the same as the generic name of the drug Incorrect Feedback: The chemical name is not the same as the generic name of a drug. d. all of the above Incorrect Feedback: Only one of the answers is correct. 31. All of these trade names reflect the disease condition the drugs are used to treat EXCEPT ____. a. Dermasil b. Pepcid c. Azmacort d. Rythmol Answer: a. Dermasil Correct Feedback: Tip 3: The drug manufacturer selects a trade name that indicates what part of the body is being treated. Dermasil is a lotion for the skin. b. Pepcid Incorrect Feedback: This does reflect the disease condition it is used to treat: peptic ulcers. c. Azmacort Incorrect Feedback: This does reflect the disease condition it is used to treat: asthma. d. Rythmol Incorrect Feedback: This does reflect the disease condition it is used to treat: an irregular heart rhythm. 32. 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 their new drug patent d. allowing the drug companies to market the drug to children Answer: c. a six-month extension on their new drug patent Correct Feedback: Drug manufacturers who agree to test their new drugs on children so that pediatric doses can be standardized, receive a six-month extension on the standard 17-year patent on new drugs. a. a cash back refund Incorrect Feedback: The FDA does not give a cash back refund to drug companies. b. speeding up the process for getting a trademark for the drug Incorrect Feedback: A trademark is issued by the U.S. Patent Office, not the FDA. d. allowing the drug companies to market the drug to children Incorrect Feedback: If a drug is tested on children and approved by the FDA it would automatically be allowed to be marketed to children. 33. Placebos commonly are _____. a. injections of sterile normal saline b. genetically engineered drugs c. sugar pills d. a and c Answer: d. a and c Correct Feedback: Placebos are commonly sugar pills or injections of sterile normal saline solution. a. injections of sterile normal saline Incorrect Feedback: This is true, but it is not the only correct answer. b. genetically engineered drugs Incorrect Feedback: A placebo is a drug that has no therapeutic effect. Genetically engineered drugs always have a therapeutic effect. c. sugar pills Incorrect Feedback: This is true, but it is not the only correct answer. 34. A moisture-absorbing packet of silica gel, known as _______, is something that would be added to a drug container during the manufacturing process. a. pharmacogenomics b. a vector c. an isomer d. a dessicant Answer: d. a dessicant Correct Feedback: The manufacturing process also includes securing the drug in an appropriate container. This could require adding a packet of a desiccant (a moisture-absorbing silica gel), if necessary. a. pharmacogenomics Incorrect Feedback: Pharmacogenomics uses genome technology to discover new drugs; this is not related to the manufacturing process. b. a vector Incorrect Feedback: A vector is something such as a virus that carries a gene into a body cell; it is not related to the manufacturing process. c. an isomer Incorrect Feedback: An isomer is a drug with the same chemical formula as another drug; it is not related to the manufacturing process. 35. 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 Answer: d. is done by the drug company and the FDA to monitor drug safety Correct Feedback: The drug companies and the FDA continue to monitor the effectiveness and safety of approved drugs. This is known as post-marketing surveillance. a. is a type of direct-to-consumer advertising Incorrect Feedback: Direct-to-consumer advertising is not related to postmarketing surveillance. b. is performed by the Federal Trade Commission Incorrect Feedback: The Federal Trade Commission regulates the advertising of over-the-counter drugs, but does not do post-marketing surveillance. c. involves adding a National Drug Code to each drug package Incorrect Feedback: There is a National Drug Code on each drug package, but it is put there to identify the drug manufacturer, drug strength, and package size and type, not to do post-marketing surveillance. 36. 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 Answer: a. a placebo used in double-blind studies Correct Feedback: A placebo is sterile water or normal saline, not a new drug discovered in the environment. A placebo is a drug form that exerts no pharmacologic effect, no therapeutic effect, and has no side effects when administered. b. a chemotherapy drug derived from yew tree needles Incorrect Feedback: This is an example of a drug discovered in the environment. c. cephalosporin antibiotic drugs from a fungus in a sewer outlet Incorrect Feedback: This is an example of a drug discovered in the environment. d. an antituberculosis drug from the stomach of a sick chicken Incorrect Feedback: This is an example of a drug discovered in the environment. 37. 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 Answer: d. all of the above Correct Feedback: Dextrorotary drugs (such as dextromethorphan) and levorotary drugs (such as levothyroxine) are examples of isomers that are rotated and are the right-facing mirror image compared to a related isomer (dextr/o- means right.) a. is an isomer Incorrect Feedback: This is true, but it is not the only correct answer. b. has a right-facing image for its molecular structure Incorrect Feedback: This is true, but it is not the only correct answer. c. example is that of dextromethorphan Incorrect Feedback: This is true, but it is not the only correct answer. 38. 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 Answer: d. all of the above Correct Feedback: A computer can display the molecular structure of any drug from a listing of thousands contained in its database. 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. a. display the molecular structure of any drug in its database Incorrect Feedback: This is true, but it is not the only correct answer. b. identify chemicals that would probably not be successful in treating a particular disease, which saves time and money Incorrect Feedback: This is true, but it is not the only correct answer. c. rotate any molecule in three dimensions on the computer screen Incorrect Feedback: This is true, but it is not the only correct answer. 39. 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 Answer: d. all of the above Correct Feedback: Drugs created through recombinant DNA technology include recombinant human erythropoietin, recombinant human growth factor, recombinant clotting factors, and others. a. clotting factors Incorrect Feedback: This is true, but it is not the only correct answer. b. erythropoietin Incorrect Feedback: This is true, but it is not the only correct answer. c. human growth factor Incorrect Feedback: This is true, but it is not the only correct answer. 40. An isomer is a drug that has the same chemical formula as another drug, but has those atoms arranged in a different way. Answer: True Feedback: An isomer is a drug that has the same chemical formula (same types and numbers of atoms in its molecule) as another drug, but has those atoms arranged in a different way. 41. Once a drug has received its final approval from the FDA, its ingredients, doses, manufacturing process, labeling, and packaging cannot be changed. Answer: True Feedback: Once a drug has received its final approval from the FDA, its ingredients, doses, manufacturing process, labeling, and packaging cannot be changed. 42. The advertising of both prescription and OTC drugs is regulated by the FDA. Answer: False Feedback: The advertising of over-the-counter drugs is regulated by the Federal Trade Commission. The advertising of prescription drugs is regulated by the FDA based on the Federal Food, Drug, and Cosmetic Act. 43. Even though drug manufacturers are held to the linguistic standards of the FDA, some trade name drugs are often difficult to spell. Answer: False Feedback: Some trade name drugs are difficult to spell because drug manufacturers are not held to any linguistic standards. 44. No matter how a drug was originally discovered or designed, it must be thoroughly tested by the FDA before it can be marketed. Answer: False Feedback: No matter how a drug was originally discovered or designed, it must be thoroughly tested by the drug company before it can be marketed. It is tested to determine the drug’s effectiveness and safety according to certain guidelines specified by the FDA. 45. Generic drugs as well as trade name drugs that are in the same drug form and have the same dose strength must all contain exactly the same active ingredients and must be able to be administered in the same way. Answer: True Feedback: Generic drugs, as well as trade name drugs that are in the same drug form and have the same dose strength—even if they are from different drug companies—must all contain exactly the same active drug ingredient and must be able to be administered in exactly the same way. 46. 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 lost during the testing process. Answer: True Feedback: A drug company is protected by a 17-year patent on any new drug that is approved by the FDA. This means that, during those 17 years, no other company can manufacture or market an identical drug. However, part of the 17-year patent period is used up during the testing process before the drug is even approved. 47. Once a drug has been approved by the FDA, the drug is guaranteed to stay on the market indefinitely because it has received FDA approval. Answer: False Feedback: Just because a drug has been approved by the FDA and is on the market does not guarantee that it will remain on the market indefinitely. 48. Many drugs still in use today were originally taken from plant, animal, or mineral sources hundreds or even thousands of years ago. Answer: True Feedback: Many drugs still in use today were originally derived from plant, animal, or mineral sources hundreds or even thousands of years ago. 49. 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. Answer: True Feedback: 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. 50. The animal phase of drug testing precedes testing on humans. Answer: True Feedback: The animal phase of drug testing precedes testing on humans. 51. The pharmacodynamics of a drug are tested during the human phase of drug testing. Answer: False Feedback: During the animal phase of drug testing, the pharmacodynamics of the drug are explored. 52. 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. Answer: True Feedback: The higher the therapeutic index, the more desirable it is, because it indicates that the drug has a wide margin of safety. 53. 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. Answer: True Feedback: While it is physiologically impossible for a placebo to exert any pharmacologic effect, patients often report a decrease in certain types of symptoms and can even experience “side effects” when given a placebo. 54. Every drug company must provide the FDA with a complete list of all prescription drugs they currently have on the market. Answer: True Feedback: Every drug company must provide the FDA with a complete list of all of the prescription drugs they currently have on the market. 55. In double-blind studies, each patient receives both the drug and a placebo. Answer: False Feedback: In a double-blind study with the drug and a placebo, neither the patients nor the physician-investigators know which patients are receiving the drug and which patients (the control group) are receiving the placebo. 56. 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. Answer: False Feedback: In a double-blind study with the drug and a placebo, neither the patients nor the physician-investigators know which patients are receiving the drug and which patients (the control group) are receiving the placebo. 57. A placebo uses the power of suggestion to produce changes in the body that mimic the pharmacologic action of an actual drug. Answer: True Feedback: The power of suggestion can produce changes within the body that closely mimic the pharmacologic action of an actual drug. 58. Genetic engineering came about as a result of deciphering the human genome. Answer: False Feedback: Recombinant DNA technology (rDNA) is also known as gene splicing or genetic engineering. Gene therapy was the result of deciphering the human genome. 59. 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. Answer: True Feedback: 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. 60. In gene therapy, a normal version of the gene is linked to a harmless virus, known as a ______, that carries the gene into body cells affected by the disease. Answer: vector Feedback: In gene therapy, a normal version of the gene is linked to a harmless virus, known as a vector that carries the gene into body cells affected by the disease. 61. When animal studies are completed, the drug manufacturers submit an IND application to the FDA. The abbreviation IND stands for ________. Answer: Investigational New Drug Feedback: Feedback: When animal studies are completed, the drug manufacturer submits an IND application to the FDA. The abbreviation IND stands for Investigational New Drug. 62. There are three phases of human testing, which together are known as _______. Answer: clinical trials Feedback: There are three phases of human testing, which are known as clinical trials. 63. A _______, a drug that has no pharmacologic effect, is often used in double-blind studies during phase III clinical trials. Answer: placebo Feedback: A placebo (drug form that exerts no pharmacologic effect, therapeutic effect, or side effects when administered) is often used in double-blind studies during phase III. 64. 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 and waits for a final FDA decision for approval or denial. The abbreviation NDA stands for ______. Answer: New Drug Application Feedback: Once phase III is completed, the drug company submits all of its documentation on the drug to the FDA in a New Drug Application (NDA) and waits for a final FDA decision for approval or denial. 65. DTC marketing has become common, beginning with magazine ads and moving to television. The abbreviation DTC stands for _____. Answer: direct-to-consumer Feedback: Direct-to-consumer (DTC) marketing has become common, beginning with magazine ads and moving to television. 66. The _______ of the active drug ingredient can be particularly crucial in drugs with a low therapeutic index. Answer: bioavailability Feedback: The bioavailability of the active drug ingredient can be particularly crucial in drugs with a low therapeutic index (a low margin of safety between the therapeutic dose and the toxic dose). 67. Define these abbreviations. FDA ______________ DTC ______________ TI ________________ IND _______________ NDC ______________ Answer: FDA (Food and Drug Administration) DTC (direct-toconsumer (advertising)) TI (therapeutic index) IND (Investigational New Drug) NDC (National Drug Code) 68. Darlene Ellis has been prescribed the drug Nasalcrom. From the trade name of the drug, you can tell that the drug is used to treat this part of her body: ____. Answer: Nose Feedback: Tip 3: The drug manufacturer selects a trade name that indicates what part of the body is being treated. Nasalcrom is used to treat nasal allergies. 69. 1. frequency distribution curve A. relative margin of safety between the dose that produces a therapeutic effect and the dose that produces a lethal effect in animals 2. half-life B. shows the number of people who responded or do not respond to a drug and at what doses. 3. median effective dose (ED50) C. the dose at which 50 percent of the animals tested had toxic levels of the drug 4. median toxicity dose (TD50) D. the dose at which 50 percent of the animals tested show a therapeutic response to the drug 5. therapeutic index (TI) E. the time required for drug levels in the serum to decrease from 100 percent to 50 percent. Answer: B Answer: E Answer: D Answer: C Answer: A Feedback: Frequency distribution curve: The number of people who respond or do not respond to the drug and at what dose. Half-life: The time required for the drug level in the serum to decrease from 100 percent to 50 percent. Median effective dose (ED50): The dose at which 50 percent of animals tested show a therapeutic response to the drug. Median toxicity dose (TD50): The dose at which 50 percent of animals tested had toxic levels of the drug. Therapeutic index (TI): The relative margin of safety between the dose that produces a therapeutic effect and the dose that produces a lethal effect in animals. 70. 1. diazepam (Valium) A. a totally new chemical created through genetic DNA manipulation 2. Aranesp B. a totally new chemical derived from molecular manipulation of a drug that is already in use 3. fexofenadine (Allegra) C. a totally new chemical substance discovered in the 4. human insulin (Humulin) 5. streptomycin environment, from plants, animals, or the soil Answer: B Answer: 2. B Answer: 3. Answer: B Answer: 4. A Answer: 5. C Feedback: Working with the chlordiazepoxide molecule, the same researcher then derived diazepam (Valium). When researchers added two more sugar molecules to the molecular structure of erythropoietin, they created the new drug Aranesp. Researchers modified the chemical structure of terfenadine (Seldane) to derive the new drug fexofenadine (Allegra). Human insulin (Humulin) became the first recombinant DNA technology drug to be approved by the FDA. The antituberculosis drug streptomycin was first isolated from the stomach of a sick chicken. 71. In addition to concerns about unexpected adverse effects of drugs, the FDA also removes certain batches of drugs from the market because of manufacturing defects. Name three manufacturing defects that would be the reasons for a drug recall. Answer: (1) The drug does not contain the correct amount of active ingredient. (2) The drug does not remain stable until its expiration date. (3) The drug is contaminated with particulate matter from the manufacturing process. 72. Briefly explain the difference between in vivo testing and in vitro testing. Answer: Chemical analysis of a drug done in a laboratory in test tubes is known as in vitro testing (in vitro is Latin for in glass). Testing carried out in animals or humans is known as in vivo testing (in vivo is Latin for in living). 73. Briefly explain how a double-blind study is performed using a control group, a placebo, and drug group. Answer: A double-blind study with a drug and a placebo is performed so that neither the patients nor the physician-investigators know which patients are receiving the drug and which patients (the control group) are receiving the placebo. The two groups, the group receiving the drug and the control group, are then compared. Test Bank for Understanding Pharmacology for Health Professionals Susan M. Turley 9780135145708, 9780133911268
