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103 Cards in this Set
- Front
- Back
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The 1938 federal Food, Drug and Cosmetic act did which of the following?
a) Prohibited fraudulent therapeutic claims b) Allowed the FDA to inspect the manufacturing process for new drugs c) Defined which drugs could be sold over-the-counter d) Defined what a dietary supplement is and how it must be labeled e) All of the answers are true |
b) Allowed the FDA to inspect the manufacturing process for new drugs
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A drug is defined as?
a) Any chemical sold in a Pharmacy b) Any chemical substance used in the diagnosis and treatment of disease c) Any chemical substance used in humans for therapeutic purposes d) Any synthetic chemical substance used in the diagnosis and treatment of disease e) None of the answers are correct |
b) Any chemical substance used in the diagnosis and treatment of disease
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Which of the following statements is/are true?
a) Most new drugs are specifically designed to be used for a specific therapeutic use b) Beta blocker use for hypertension is an example of an unintentionally designed drug use c) Most drugs are derived from natural products d) Adverse effects are usually just an extension of the therapeutic actions and occur by the same mechanism e) None of the answers are true |
b) Beta blocker use for hypertension is an example of an unintentionally designed drug use
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The 1906 Food and Drug Act did which of the following?
a) Required safety testing for all new pharmaceuticals. b) Required labels to be accurate and complete c) Established the legal definition of a drug d) Established the Bureau of Chemistry e) None of the answers are correct |
d) Established the Bureau of Chemistry
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Which of the following is true?
a) In the CAST study the drug caused a three fold increase in the number of cardiac deaths versus placebo. b) The cardiac arrhythmia Suppression test (CAST) measured the ability of Encanide and Flecanide to reduce premature ventricular contractions vs placebo c) Rezulin caused significant liver toxicity and required several liver transplants before it was removed from the market d) None of the answers are true e) All of the answers are true |
e) All of the answers are true
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Pharmacodynamics is defined as?
a) What the body does to the drug b) The role genetic variation plays in the mechanism of a drug’s action c) Why you see adverse effects after drug administration d) How absorption and excretion affect a drug’s mechanism of action e) None of the answers are correct |
e) None of the answers are correct
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Which of the following statements is/are true?
a) All therapeutic uses of drugs are rational b) The main function of drugs is to cure disease c) Investigational New drug applications (IND’s) are submitted to the FDA prior to clinical testing d) On average 12 new drugs are approved by the FDA each year e) All the answers are true |
c) Investigational New drug applications (IND’s) are submitted to the FDA prior to clinical testing
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The 1906 Pure Food and Drug Act established the FDA as we know it today.
The 1912 Sherley amendment required the correct listing of all ingredients on the label. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
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Pharmacodynamics is the study of the effects drugs have on bodily functions.
Vitamins meet our working definition of a drug. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
C = The first statement is true, the second statement is false
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The 1938 Federal Food, Drug and Cosmetic act required for the first time safety and effectiveness testing of all new drugs.
The 1951 Durham-Humphrey amendment defines the requirements for prescription drugs. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
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All drugs are developed with a predetermined therapeutic use.
An Investigational New Drug (IND) application is submitted prior to any screening or toxicity testing. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
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The therapeutic and adverse effects of drugs may occur through different receptor mediated mechanisms.
Knowledge of the correct mechanism of action of a drug is required for FDA approval. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
C = The first statement is true, the second statement is false
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The CAST (cardiac arrhythmia suppression test) study was designed to measure whether Encanide and Flecanide could prevent (PVC’s) premature ventricular contractions in previous MI patients.
Not all therapeutic drug use is rational. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
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Which of the following is/are true?
a. Rezulin was removed from the market because of increased risk of congestive heart failure b. The VIGOR trial compared the use of Bextra with Vioxx in terms of GI safety c. The combination of Fenfluramine and Phentermine was FDA approved for weight loss d. Avandia received FDA black box warnings because of liver toxicity e. All of the above are correct f. None of the above are correct |
f. None of the above are correct
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The 1906 Pure Food and Drug Act established the Bureau of Chemistry.
The 1912 Sherley amendment prohibited fraudulent therapeutic claims. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
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Pharmacokinetics is the study of the effects drugs have on bodily functions.
Vitamins are not considered drugs under the 1994 Dietary Supplement Health and Education act. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
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The 1938 Federal Food and Cosmetic act required for the first time safety testing of all new drugs.
The 1951 Durham-Humphrey amendment defines the requirements for prescription drugs. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
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All drugs are developed with a predetermined therapeutic use.
An Investigational New Drug (IND) application is submitted prior to clinical testing. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
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The therapeutic and adverse effects of drugs always occur through the same receptor mediated mechanisms.
Knowledge of the correct mechanism of action of a drug is required for FDA approval. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
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The CAST (cardiac arrhythmia suppression test) study was designed to measure whether Encanide and Flecanide could prevent (PVC’s) premature ventricular contractions in previous MI patients.
All therapeutic drug use is rational. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
C = The first statement is true, the second statement is false
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Which of the following is/are true?
a. Rezulin was removed from the market because of increased risk of liver toxicity b. The VIGOR trial compared the use of Naproxen with Vioxx in terms of GI safety c. The combination of Fenfluramine and Phentermine was not approved by the FDA for weight loss d. Avandia received FDA black box warnings because of cardiac toxicity e. All of the above are correct f. None of the above are correct |
e. All of the above are correct
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The 1906 Food and Drug Act did which of the following?
a. Required safety and effectiveness testing for all new pharmaceuticals. b. Required accurate listing of all ingredients c. Established the legal definition of a drug d. Established the Food and Drug Administration e. None of the answers are correct |
b. Required accurate listing of all ingredients
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The Durham-Humphrey amendment did which of the following?
a. Prohibited fraudulent therapeutic claims b. Allowed the FDA to inspect the manufacturing process for new drugs c. Defined which drugs could be sold over-the-counter d. Defined what a dietary supplement is and how it must be labeled e. All of the answers are true |
c. Defined which drugs could be sold over-the-counter
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Pharmacodynamics is defined as?
a. What a drug does to the body b. The role genetic variation plays in the mechanism of a drugs action c. Why you see adverse effects after drug administration d. How absorption and excretion affect a drugs mechanism of action e. None of the answers are correct |
a. What a drug does to the body
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Which of the following statements is/are true?
a. Most new drugs are specifically designed for their specific therapeutic use b. Minoxidil use for hair growth is an example of an intentionally designed drug use c. Most drugs are derived from natural products d. Adverse effects are usually just an extension of the therapeutic actions and occur by the same mechanism e. None of the answers are true |
e. None of the answers are true
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Which of the following statements is/are false
a. All therapeutic uses of drug is rational b. The main function of drugs is to cure disease c. New drug applications (NDA) are submitted to the FDA prior to clinical testing d. On average 12 new drugs are approved by the FDA each year e. All the answers are false |
e. All the answers are false
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Which of the following COX 2 inhibitors have been removed from the market?
a. Vioxx only b. Celebrex only c. Bextra only d. Vioxx and Bextra e. All the COX 2 inhibitors have been removed from the market |
d. Vioxx and Bextra
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Which of the following is false?
a. In the CAST study the drug caused a three fold increase in the number of cardiac death versus placebo. b. The cardiac arrhythmia Suppression test (CAST) measured the ability of Encanide and Flecanide to reduce premature ventricular contractions vs placebo c. Rezulin caused significant renal toxicity and required several renal transplants before it was removed from the market d. None of the answers are false e. All of the answers are false |
c. Rezulin caused significant renal toxicity and required several renal transplants before it was removed from the market
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The 1906 Federal Pure Food and Drug Act required registration of addicting substances.
The 1912 Sherley Amendment established the Bureau of Chemistry, which is the predecessor to the FDA. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
C = The first statement is true and the second statement is false
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The 1938 Federal Food, Drug and Cosmetic Act defined the requirements for prescription drugs.
The Durham-Humphrey Amendment required the statement “Caution: Federal law prohibits dispensing without prescription. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
D = The first statement is false and the second statement is true
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Vitamins were excluded from direct FDA regulation by the 1994 Dietary Supplement Health and Education Act.
All chemicals are regulated by the FDA. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
C = The first statement is true and the second statement is false
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FDA approval of a drug requires meeting safety and efficacy standards.
Most drug use is to alleviate symptoms. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
A = Both statements are true
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The therapeutic and adverse effects of drugs always occur through different receptor mediated mechanisms.
The mechanism of action of a drug must be known before FDA approval of use is allowed. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
B = Both statements are false
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New Drug Applications (NDA’s) are submitted to the FDA only after completion of Phase 3 clinical trials.
Investigational New Drug applications (IND’s) must be submitted before submitting a patent and before any testing of a new chemical can begin. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
C = The first statement is true and the second statement is false
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Which of the following is/are true?
A. The average time for FDA approval is 10-15 years. B. A new drug receives FDA approval every three months. C. Use of prescription drugs for weight loss is always a rational use of drugs. D. The FDA may limit the time a new drug may be under investigation. E. All of the above are correct. F. None of the above are correct. |
A. The average time for FDA approval is 10-15 years.
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Which of the following is/are true?
A. Most drugs used today are synthetic. B. Minoxidil use for hair loss is an example of rational drug design. C. The Cardiac Arrhythmia Suppression Trial measured ability of Flecanide and Encanide to prevent death due to myocardial infarction. D. Rezulin, an oral anti hyperglycemic, was removed from the market for causing significant renal toxicity. E. All of the above are correct. F. None of the above are correct. |
A. Most drugs used today are synthetic.
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Which of the following would require a prescription for use?
A. Drugs deemed to be habit forming B. Cough syrup containing codeine C. Drugs given by injection D. New drugs undergoing clinical trials E. All of the above are correct F. None of the above are correct |
E. All of the above are correct
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Which of the following is/are true?
A. Pharmacodynamics deals with information about drug distribution in the body B. Toxicology only deals with chemicals we defined as drugs C. Pharmacokinetic properties are not important in the therapeutic actions of drugs D. Pharmacogenomics deals with the role genetics plays in how we respond to drugs E. All of the above are correct F. None of the above are correct |
D. Pharmacogenomics deals with the role genetics plays in how we respond to drugs
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In which of the following cases would the use of the agent mentioned be regulated by the FDA?
A. Use of morphine to treat an injured dog B. Use of Vitamin C to help prevent a cold C. Use of Saw Palmetto (a natural product) in benign prostatic hyperplasia D. Use of St. Johns Wort (a natural product) for mild depression E. All of the above are correct F. None of the above are correct |
A. Use of morphine to treat an injured dog
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The Kefauver-Harris amendment
A. Required safety testing of drugs approved after 1938 B. Defined over the counter medication C. Allowed for compassionate use of drugs without prescriptions D. Was repealed by the 1994 Dietary Supplement Health and Education Act E. All of the above are correct F. None of the above are correct |
A. Required safety testing of drugs approved after 1938
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The 1938 Federal Food and Drug Act
1. Changed the name of the Bureau of Chemistry to the Food and Drug Administration 2. Allowed manufacturing inspections by the FDA 3. Created the over-the-counter designation for drugs used without medical supervision 4. Required safety testing of all new drugs A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
C = Only 2 and 4 are correct
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The 1962 Kefauver-Harris amendment
1. Allows the FDA to regulate vitamins and health foods 2. Defined drugs requiring prescriptions 3. Required correct listing of all ingredients on the labels 4. Required safety and effectiveness testing for all new drugs A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
D = Only 4 is correct
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Which of the following is/are true?
1. The cardiac arrhythmia suppression teat (CAST) measured the ability of Encanide and Flecanide to reduce premature ventricular contractions vs placebo 2. In the CAST study the experimental drugs caused a three fold increase in the number of cardiac deaths vs placebo 3. Rezulin caused significant liver toxicity and required several liver transplants before it was removed from the market 4. The CAST study resulted in Flecanide and Encanide being removed form the market A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
A = Only 1,2 and 3 are correct
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Which of the following is/are false?
1. Logos means study. 2. An Investigational New drug Application (IND) is required before clinical testing in humans. 3. Toxicology deals with chemicals used for any purpose. 4. A drugs mechanism of action must be known before FDA approval can be granted. A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
D = Only 4 is correct
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A drug is defined as?
1. Chemicals sold by prescription 2. Any chemical substance used in humans 3. Any synthetic chemicals used for the diagnosis and treatment of disease 4. Any natural product A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
F = None of the statements are correct
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Most new drugs are specifically designed for their current therapeutic use.
Adverse effects of drugs are an extension of their therapeutic actions and usually occur through the same receptor mechanisms. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
B = Both statements are false
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New drug applications are submitted after toxicity testing has been completed but before clinical testing begins.
FDA approval is limited to 24 drugs/year. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
B = Both statements are false
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The main function of drugs is to treat symptoms
Minoxidil use for hair growth is a rational use of drugs. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
C = The first statement is true and the second statement is false
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Phase 4 clinical trials must be completed before a new drug application can be submitted.
Vioxx® increased heart risk 2 fold over placebo in the APPROVE study. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true |
D = The first statement is false and the second statement is true
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Drugs requiring the label statement “ Caution Federal Law prohibits dispensing without a prescription” include:
A. Drugs given by injection B. Morphine and cocaine C. Drugs limited to investigational use D. Drugs administered by a licensed practitioner E. All of the above F. None of the above |
E. All of the above
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Which of the following is/are true?
A Minoxidal use for hair loss is an example of rational drug design B. Logos means study C. The purpose of a NDA (new drug application) is to determine a drug’s mechanism of action. D. An IND (investigational new drug application) is required before drug testing can begin in humans. E. A and C F. B and D |
F. B and D
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Which of the following is/are true?
A. There are over 13,000 prescription drugs available in the US. B. On average one new drug is approved by the FDA each year. C. A drug must be reviewed by the FDA for a least 24 months before approval. D. Patients over 65 account for ~50% of prescription drug use. E. All of the above F. None of the above |
A. There are over 13,000 prescription drugs available in the US.
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Which of the following is/are false?
A. A drug refers to a chemical used only for treatment of disease B. Pharmacogenomics deals with altered absorption, distribution or biotransformation due to altered drug structure C. Toxicology deals only with chemicals used for medical purposes D. Pharmacokinetic parameters are important for understanding the mechanism by which a drug acts. E. All of the above are false F. None of the above are false. |
E. All of the above are false
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The FDA regulates all chemicals meeting our classroom definition of a drug.
The FDA under the 1994 Dietary Supplement Health and education Act regulates vitamins. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
C = The first statement is true and the second statement is false
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Most drugs in use today were designed to cure disease.
FDA approval of a drug assures safety and effectiveness of a drug. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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The 1906 Federal Pure Food and Drug Act prohibited fraudulent therapeutic drug claims.
The 1912 Sherley Amendment established the Bureau of Chemistry, which is the predecessor of the FDA. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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The 1938 Federal Food, Drug and Cosmetic act required safety testing of new drugs.
The 1938 Federal Food, Drug and Cosmetic act also defined the requirements for a prescription drug. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
C = The first statement is true and the second statement is false
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1994, Dietary Supplement, Health and Education Act requires effectiveness testing of herbal medications.
1994, Dietary Supplement Health and Education Act allows the FDA to regulate therapeutic claims of dietary supplements. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
D = The first statement is false and the second statement is true.
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Drug treatment to reduce weight in the clinically obese is a rational use of drugs.
Pharmacokinetic properties of a drug are important in the therapeutic response of a drug. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
A = Both statements are true
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The 1962 Kefaurer-Harris Amendment created the over-the-counter designation for drugs used without medical supervision.
In 1952 the Durham-Humphrey Amendment finally required the FDA to test for both safety and effectiveness. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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Therapeutic and adverse effects usually occur through the same receptor mechanisms.
It is necessary to understand the mechanism of action of the drug before we use it therapeutically. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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Phase III clinical studies require a minimum of 100,000 patients to receive the new drug before FDA review.
The Approve study (2000) was a placebo-controlled study to compare the effectiveness of Vioxx with Naproxen on GI bleeding. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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All chemicals are regulated by the FDA.
The majority of drugs available today can be considered to cure the underlying disease they are used to treat. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
B= Both statements are false:
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Pharmacokinetics deals with what the body does with the drug.
Pharmacodynamics deals with what the drug does to the body. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
A= Both statements are true:
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FDA approval of a drug assures safety and efficacy of a drug.
Most drugs are designed to treat the symptoms of disease. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
D= The first statement is false and the second statement is true:
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Individuals over the age of 64 account for a disproportionate use of all prescriptions.
Side effects of drugs are always considered adverse effects. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
C= The first statement is true and the second statement is false:
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Which of the following is /are correct?
1. Most drugs come from natural sources 2. Minoxidil use for hair loss is an example of rational drug use. 3. The mechanism of action of a drug must be known before FDA approval. 4. Pharmakon means drug or poison A = 1,2 3 are correct B = 1 and 3 are correct C = 2 and 4 are correct D = 4 is correct E = All are correct |
D = 4 is correct
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Which of the following is/are true ?
1. There are over 13,000 prescription drugs. 2. On average 6 new drugs are approved by the FDA each year. 3. 2/3 of physician visits result in prescriptions. 4. Patent life for a new drug is 27 years. A = 1,2 3 are correct B = 1 and 3 are correct C = 2 and 4 are correct D = 4 is correct E = All are correct |
B = 1 and 3 are correct
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Which of the following factors explains why we don't understand how drugs work?
1. Multiple mechanisms of action 2. Knowledge base has not been expanded sufficiently 3. Proposed mechanism doesn't correlate with therapeutic time course 4. FDA limits the time a new drug may be under investigation. A = 1,2 3 are correct B = 1 and 3 are correct C = 2 and 4 are correct D = 4 is correct E = All are correct |
A = 1,2 3 are correct
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Which of the following is /are false?
1. Toxicology deals mainly with adverse effects of drugs 2. Insulin is an example of a drug from natural sources 3. The Cardiac Arrhythmia Suppression Test was designed to examine control of atrial fibrillation 4. Drugs may bind to multiple receptors to produce therapeutic effects. A = 1,2 3 are correct B = 1 and 3 are correct C = 2 and 4 are correct D = 4 is correct E = All are correct |
A = 1,2 3 are correct
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Pharmacology is defined as the basic and clinical applied science that concerns itself with how drugs are affected by the body.
Toxicology deals with adverse effects to chemicals due mainly to environmental exposure. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
B= Both statements are false:
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Drug refers only to those chemicals approved by the FDA.
Natural products are no longer used as sources for new drugs. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
B= Both statements are false:
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The use of Minoxidil for hair loss is an example of accidental drug design.
Drugs approved by the FDA have been screened to have only beneficial effects. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
C= The first statement is true and the second statement is false:
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Drugs usually have only a single mechanism of action to account for both beneficial effects and side effects.
Drugs may bind to multiple receptors. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
D= The first statement is false and the second statement is true:
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Understanding the mechanism of action is not a prerequisite for FDA approval of a drug.
Antidepressants produce biochemical changes in a matter of days but take weeks to develop clinical effects. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
A= Both statements are true:
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Most drugs used today are for the treatment of disease symptoms.
The total number of FDA approved drugs is limited by law to 5,000 compounds. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
C= The first statement is true and the second statement is false:
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The IND (Investigational New Drug application) is filed by a company after clinical testing to get FDA approval.
Phase 3 clinical trials require at least 100,000 patients to receive the new drug. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
B= Both statements are false:
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The Cardiac Arrhythmia Suppression Test (CAST) was a placebo controlled blind study to determine the effectiveness of drugs against ventricular fibrillation.
Rezulin @ (Troglitazone) was removed from the market due to liver and heart toxicity. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
D= The first statement is false and the second statement is true:
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Fen-Phen (Fenfluramine and Phenteramine) was not an approved treatment for obesity.
Drug treatment to reduce weight in the clinical obese is a rational use of drugs. A= Both statements are true: B= Both statements are false: C= The first statement is true and the second statement is false: D= The first statement is false and the second statement is true: |
A= Both statements are true:
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The 1906 Pure Food and Drug Act established the legal definition of a drug
The 1938 Federal Food, Drug and Cosmetic act defined which drugs could be sold over the counter. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
(F) (under other legisislation) (F) (1951 Durham-Humphru) |
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The 1912 Sherley amendment prevented misbranding and adulteration of food, drinks or drugs.
The deaths from the introduction of the Elixir of Sulfanilamide were a significant factor in the passage of the 1938 Federal Food, Drug and Cosmetic act. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
(F) (1906 law) (T) |
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Adverse effects of drugs are usually just an extension of their therapeutic actions and usually occur by the same mechanism.
Beta blockers used to lower blood pressure in hypertension are an example of intentional drug design. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
(F) (May not be related) (F) (found accidentally) |
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Investigational new Drug applications (IND’s) are submitted to the FDA prior to phase 1 clinical trials
Most of the 33 drugs approved by the FDA in 2008 were considered “me too” drugs because their mechanisms are similar to drug already approved. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
(T) (T) |
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The 1951 Humphrey-Durham amendment defines the requirements for a prescription drug.
The 1998 Pediatric rule requires pediatric dosing levels to be included on the label for all FDA approved drugs. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
C = The first statement is true, the second statement is false
(T) (F) (does not require) |
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Phase 4 clinical testing is not required for most drugs approved by the FDA. It is only required for drugs if there is a suspicion of severe life threatening side effects, that have a low prevalence rate in the population.
The COX2 inhibitors have all been withdrawn from the market because of the increased incidence of stroke, MI or blood clots. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
(F) (required of all) (F) (celebrex still on market) |
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Which of the following is/are true?
1. Rezulin was removed from the market berceuse of kidney failure which required several patients to have kidney transplants 2. Pharmacodynamics is the study of what the body does to the drug 3. Prior to FDA approval of all therapeutic drugs, the mechanism of action must be known 4. The cardiac arrhythmia suppression test (CAST) measured the ability of Encanide and Flecanide to suppress PVC’s in patients after MI’s |
4. The cardiac arrhythmia suppression test (CAST) measured the ability of Encanide and Flecanide to suppress PVC’s in patients after MI’s
(liver problems) (Pharmcokinetics) (must not be known) |
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The 1906 Pure Food and Drug Act established the “Poison squad” which was established to determine the safety of chemical preservatives
The 1938 Federal Food, Drug and Cosmetic act allowed the FDA to inspect the manufacturing process A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
(F) (established in 1902) (T) |
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The 1912 Sherley amendment required the listing on the label of addicting substances
The deaths from the introduction of the Elixir of Sulfanilamide were a significant factor in the passage of the 1906 Pure Food and Drug Act A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
B = Both of the statements are false
(F) (1906 act) (F) (1938 law) |
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Adverse effects of drugs are usually not just an extension of the therapeutic actions and may occur by the a separate mechanism
Beta blockers used to lower blood pressure in hypertension are an example of accidental drug design A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
(T) (T) |
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New drug applications (NDA’s) are submitted to the FDA after phase 4 clinical trails.
Seven of the drugs approved by the FDA in 2008 were considered new drug classes because their mechanism is novel. A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
(F) (after phase 3) (T) |
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The 1951 Humphrey-Durham amendment creates the over-the-counter drug designation.
The 1998 Pediatric rule requires safety and efficacy testing for all existing and new drugs to be used in pediatric patients A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
A = Both of the statements are true
(T) (T) |
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Phase 1 clinical testing is to determine the safety and efficacy of a drug in a small number of paid volunteers.
The COX2 inhibitors interfere with the balance in actions in blood vessels between PGI2 and TXA2 A = Both of the statements are true B = Both of the statements are false C = The first statement is true, the second statement is false D = The first statement is false, the second statement is true. |
D = The first statement is false, the second statement is true.
(F) (only safety in phase 1) (T) |
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Which of the following is/are true?
1. Patients over 65 account for ~50% of prescription drug use. 2. On average one new drug is approved by the FDA each year. 3. A drug must be reviewed by the FDA for a least 24 months before approval. 4. There are over 13,000 prescription drugs available in the US. A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
D = Only 4 is correct
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Which of the following is/are true?
1. A drug refers to a chemical used only for the treatment of disease 2. Pharmacogenomics deals with absorption, distribution and biotransformation due to altered drug structure 3. Toxicology deals only with chemicals used for medicinal purposes 4. Pharmacokinetic parameters are unimportant in the drug approval process A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
F = None of the statements are correct
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Which of the following is/are true?
1. Minoxidil use for hair loss is an example of rational drug design 2. Logos means study 3. The purpose of NDA is to determine a drug's mechanism of action 4. An IND is required before drug testing can begin in humans A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
C = Only 2 and 4 are correct
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Which of the following is/are true?
1. Rezulin was removed from the market because of increased liver toxicity 2. The VIGOR trial compared the use of Vioxx with Naproxen in terms of GI safety 3. The combination of Fenfluramine and Phentermine was never approved by the FDA for weight loss 4. Avandia received FDA block box warning because of congestine heart failure and myocardial infarctions A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
E = All of the statements are correct
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Drugs requiring the label statement "Caution Federal Law Prohibits dispensing without a prescription include:
1. Drugs given by injection 2. Morphine and cocaine 3. Drugs under investigational use 4. Drugs administered by a licensed practitioner A = Only 1,2 and 3 are correct B = Only 1 and 3 are correct C = Only 2 and 4 are correct D = Only 4 is correct E = All of the statements are correct F = None of the statements are correct |
E = All of the statements are correct
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Therapeutic and adverse drug effects usually occur through the same receptor mechanisms.
It is necessary to understand the mechanism of action of a drug before we use it therapeutically. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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Most drugs in use today were designed to cure diseases.
The Durham-Humphrey Amendment required safety and effectiveness testing for all new drugs. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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The FDA regulates all chemicals meeting our classroom definition of a drug.
FDA approval of a drug requires meeting safety and efficacy standards. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
A = Both statements are true
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The 1994 Dietary Supplement, Health and Education Act requires the effectiveness testing of herbal medications.
The 1994 Dietary Supplement, Health and Education Act allows the FDA to regulate therapeutic claims for dietary supplements. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
D = The first statement is false and the second statement is true.
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The 1912 Sherley Amendment prohibited fraudulent therapeutic claims for new drugs.
The 1938 Federal Food, Drug and Cosmetic Act also defined the requirements for a prescription drug. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
C = The first statement is true and the second statement is false
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The 1906 Federal Pure Food and Drug Act prohibited fraudulent therapeutic drug claims.
The 1962 Kefauver-Harris Amendment allowed inspections of factories making FDA approved drugs. A = Both statements are true B = Both statements are false C = The first statement is true and the second statement is false D = The first statement is false and the second statement is true. |
B = Both statements are false
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