Drug Discovery 00000001

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1) The federal agency responsible for approving drugs before releasing them for public use is

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U.S. Food and Drug Administration (FDA)

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2. The 1962 Kefauver-Harris amendments were approved after babies were born with deformities as a result of

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Thalidomide

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3) A substance can be patented when:

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it has a new chemical structure

a chemical is manufactured in a new way

a new use for a chemical is discovered

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4. The cost of expensive clinical trials to demonstrate a new drug is effective typically is paid by

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The drug manufacturer seeking FDA approval

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5. The FDA publication of Approved Drug Products and Pharmaceutical-related patents

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Red Book

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7. The main responsibility of an IRB is to:

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Protect the welfare of research participants

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8. Which of the following laws established that drugs should be accurately labeled with contents and dosage

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Pure Food and Drug Act (1906)

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9. Which of the following Laws was enacted in response to the infamous Tuskegee syphilis study"

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Pure Food and Drug Act (1906)

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10. Attempted to ensure the safety and effectiveness of all new drugs introduced to the market

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Kefauver Harris Amendment (1962)

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11. A patent examiner reviews:

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Whether the drug is useful

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12. Informed consent refers to:

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A voluntary decision to participate in research, by a competent individual who has received and understood the necessary information

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13. The process where some individuals experience complete symptom reduction in the absence of any
treatment is known as

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the placebo effect

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14. A firm can commence studying a new drug by giving the drug to human subjects when

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The FDA approves an IND and the firm receives approval from the IRB.

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15. Why are some prescription drugs not available as less expensive generic drugs?

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The prescribed drug may be a \pioneer" drug and the 20-year patent-protection period may
not have expired.

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16. Which of the following describes a molecule?

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A chemical substance that results from the combination of two or more atoms

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17. During which phase in the development of pharmaceutical drugs is the drug tested on healthy human
volunteers to test for toxicity?

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phase I clinical trials

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18. Lisa Simpson invented the drug Alpha1. She could prevent anyone else from ever selling Alpha1 if:

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She would apply for a trademark

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19. A phase II trial for Alpha1 is mainly used to determine

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effective dose

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20. A new headache remedy was given to a group of 25 subjects who had headaches. Four hours after
taking the new remedy, 20 of the subjects reported that their headaches had disappeared. From this
information you conclude:

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nothing, because there is no control group for comparison

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21. When P fzer's patent for Lipitor (artovastatin calcium) expires in about a year

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P fzer is anticipated to lose revenue from the exclusivity provided by its patent even though it
can continue to sell artovastatin calcium as Lipitor exclusively.

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22. The NSAID drugs such as aspirin and Celebrex would best be classifed as

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antagonists

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01. A scientific study designed to test a medical intervention in humans known as a

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A clinical trial

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02. What drug marketed in 1937 before safety testing was required, was responsible for the deaths of more than 100 people?

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Elixir Sulfanilamide

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03. Which of the following laws established that drugs should be accurately labeled with contents and dosage

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Pure Food and Drug Act 1906

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04. Which of the following is NOT an ethical concern about placebo-controlled randomized clinical trails?

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The placebo may have unknown side effects.

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05. The 1962 Kefauver Harris amendments were approved after babies were born with deformities as a result of

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Thalidomide

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06. In what year did the FDA begin to require that a new drug be demonstrated to be effective before it could be marketed

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1962

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07. The cost of expensive clinical trials to demonstrate a new drug is effective typically is paid by

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The drug manufacturer seeking FDA approval

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08. Which phase of the FDA new drug application involves double-blind, placebo controlled trials to demonstrate that it actually works and involves hundreds or thousands of patients

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Phase 3

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09. Javier wants to study the effects on achievement of taking a course in chemistry in the afternoon rather than in the morning. Two chem classes with the same amount of students, but different teachers, at 8:30am and 1pm. Volunteer to participate in a study. A major problem with this study would be?

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Confounding variables

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10. The FDA publication of approved drug products and pharmaceutical-related patents.

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Orange Book

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11. A drug class that causes a natural biological action to NOT occur is called a?

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antagonist

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12. The brand name of a drug....

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Identifies the drug as coming from a specific manufacturer

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13. Which statement is true concerning agonist and antagonist?

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ED 50 is measured of agonist potency

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14. A drug that mimics the effect of an natural chemical in the body is called an?

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Agonist

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15. The main responsibility of an IRB is to

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Protect the welfare and research participants

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16. Three basic ethical principles which became the standard for acceptable conduct of research involving human subjects in the US, "Respect of Person", "Justice", and "Beneficence" are the guiding principles behind the IRB process. In which of the following where these principles first outlined?

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The Belmont Report

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17. ___ highlighted the vulnerability of the institutionalized children as participants in research and concerned the issue of children deliberately infected with the hepatitis virus

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Willowbrook Study

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18. Which of the following is NOT a criteria that the IRB uses to evaluate research proposals ?

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The political and community reaction to the research topic being studied

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19. A does-reponse curve is:

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A tool to compare the size of the response to the amount of the drug

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21. In class we discussed the drug Celebrex. Which of the following statements about Celebrex is correct?

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Celebrex is an antagonist

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23. If a new drug is proposed to reduce the symptoms of depression, a Phase 3 clinical study of that new drug should

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Develop a protocol which tests the proposed drug for both efficacy and safety when administered to people who have been diagnosed with depression

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24. Because of the patent and the rules of the FDA a drug is marketed under a patent

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For less than 20 years

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25. A patent examiner reviews:

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Whether the drug is useful

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26. The process where some individuals experience complete symptoms reduction in the absence of any treatment is known as the ?

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Placebo effect

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27. A firm can commence studying a new drug by giving the drug to human subjects when

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The FDA approves an IND and the firm receives approval from the IRB

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28. Why are some prescription drugs not available as less expensive generic drugs?

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The prescribed drug may be a pioneer drug and the 20 year patent protection period may not have expired

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29. Which of the following defines a molecule

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A Chemical substance that results from the combination of two or more atoms

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30. A chemical reaction

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Breaking of old and formation of new chemical bonds that result in a new molecule

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31. During which phase in the development of pharmaceutical drugs is the drug tested on a healthy human volunteer to test for toxicity?

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Phase 1 clinical trials

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32. Which one of the following statements best describes the pharmaceutical term "off label"

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Prescribing a drug for a use not approved by the FDA

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33. The patents system of supporting pharmaceutical research has the following consequences:

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It leads to higher prices for the most recently discovered drugs.

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34. When Pfizer's patent for Lipitor (artovastatin calcium) expires in about a year

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Pfizer is anticipated to lose revenue from the exclusivity provided by its patent even though it can continue to sell artovastatin calcium as Lipitor

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35. A ____ is a string of 100-1000 amino acids joined by peptide bonds

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Protein

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38. Johnson, in his research related to Zeta, also discovered some new scientific information relating to cancer. Johnson

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Published an article relating to the science of cancer, since science cannot be patented

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39. A patent on the claim that Zeta would be useful in treatment of cancer would give Johnson and the assignee the right to

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Exclude others from selling Zeta in the US for cancer

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40. On the successful completion of Phase 3 trials testing Zeta for efficacy in treating colorectal caner and approval by the FDA of the sale of Zeta for that indication

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Newcorp or its licensee could market zeta only for the indication approved by the FDA

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42. In an invention is novel and non-obvious to an expert who worksinthe feild, that is suffcient to recieve a patent from the US Patent Office (T or F)

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False

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43. Potency refers to the degree to which a drug is able to produce maximal effects (T or F)

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False

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44. A widely accepted proviso in human research is that the use of placebos is unethical when effective treatments are already available (T or F)

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True

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45. The "American Invents Act of 2011" changes the patent law in the US so that a patent is issued to the first person to invent a product or process, even though someone else may have been the first to file the patent (T or F)

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False

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46. In a double blind study a researcher tests the effectiveness of a medication so that neither the person administering nor the person receiving the treatments knows whether the subject is in the control or the experimental group (T or F)

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True

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47. One purpose of "random assignment" in clinical trial is to eliminate bias in treatments assignment, such as selection bias and confounding (T or F)

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True

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48. It is generally understood that consent to do research on children is not required (T or F)

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False

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49. The Hatch Waxman Amendment to the Food Drug and Cosmetic Act provided a mechanism for the approval of a generic drug product (T or F)

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True

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50. Approval of an abbreviated new drug application (ANDA) requires review of large clinical studies assessing the effectiveness of the product (T or F)

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False