Hi there I am having some trouble with some toxicology questions. I put an arrow

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Hi there I am having some trouble with some toxicology questions. I put an arrow next to the arrows that I thought the right answer was, but number 13 I am completely unsure about. Any reasurance or answers would be extremely helpful

1. The 1938 expansion of the Federal Food, Drug and Cosmetics Act was passed in response to the accidental poisoning of people who ingested:

A) aspirin

B) mercury

>C) elixir sulfanilamide

D) rezulin

2. Dietary supplements are monitored for safety by the FDA only after sale, under the powers granted by the:

A) Supreme Court

>B) Federal Food, Drug and Cosmetics Act of 1938

C) Food and Drugs Act of 1906

D) Dietary Supplement Health and Education Act of 1994 (DSHEA)

3. In _________________, a small group (20-100) of healthy volunteers receiving the NCE in order to verify the compound's safety and determine the appropriate dosing schedule (dose given and timing interval of treatments).

A) Pre-clinical trials

>B) Phase I trials

C) Phase II trials

D) Phase III trials

4. The goal of Phase II trials is/are:

A) assess the effectiveness of the drug against the disease

B) determine whether there are any side effects (toxicity)

>C) test the effects of the drug in a patient population

D) all of the above

E) none of the above

5. This phase involves post-approval monitoring of drug safety:

A) pre-clinical trials

B) Phase I

C) Phase II

D) Phase III

>E) Phase IV

6. The Ames bacterial mutagenesis test and the chromosome aberration test in primary human lymphocytes or other mammalian cell line are required by the FDA and ICH as tests of:

>A) genotoxicity

B) cardiotoxicity

C) immunotoxicity

D) drug-drug interactions

7. The _____________ assay measures activity of the repolarizing potassium channel that regulates ventricular heart rate.

>A) calcium channel activity

B) sodium channel activity

C) Ames

D) hERG

8. The ICH defines _____________ as " as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above."

A) toxicology

>B) safety pharmacology

C) pharmacology

D) pre-clinical trials

9. Metabolite profiling studies are often used to:

A) Identify non-human animal model species for toxicity testing

>B) Identify the metabolic pathway of the NCE

C) Determine whether induction is taking place

10. Before human clinical trials can begin, the FDA must approve a company’s:

A) Investigational New Drug application

B) Request for Drug Marketing application

C) New Drug Approval application

>D) All of the above

11. A New Drug Application (NDA) is filed after Phase ____ clinical trials.

A) I

B) II

>C) III

D) IV

12. Post-approval monitoring is also called:

A) Phase 1

B) Phase 2

C) Phase 3

>D) Phase 4

E) Phase 5

13. In vivo toxicology studies must be performed following:

A) Good manufacturing processes (GMP)

B) Good clinical practices (GCP)

C) Good laboratory practices (GLP)

D) All of the above

14. If a NCE causes QT interval prolongation in an in vitro study, this indicates high probability that the NCE will cause _______ in vivo.

>A) Cardiotoxicity

B) Reproductive toxicity

C) Respiratory toxicity

D) Genotoxicity

15. If a drug induces any isoform of CYP450, that drug cannot be approved by the FDA.

A) True

>B) False

16. Toxicity of the reproductive organs themselves is called:

A) Teratogenesis

B) Cancer

C) Offspring toxicity

>D) Reproductive toxicity

17. Times during development when organ systems are most susceptible to damage are called:

>A) Formation periods

B) Manifestations

C) Critical periods

D) Teratogen times

18. Low exposure levels to methylmercury preferentially targets the developing fetus, in comparison to the relative lack of effects in the mother. This is a classic example of which of Wilson’s six principles?

A) Specificity

B) Selectivity

>C) Dose-response effect

D) Genetic influence

19. The organ system susceptible to damage for the longest period of time during development is the:

>A) Nervous system

B) Heart

C) Palate

D) Arms

20. The drug originally used as a morning sickness therapeutic from the mid-1950s through the early 1960s, that caused birth defects including Amelia (lack of limbs), is:

>A) Thalidomide

B) Accutane

C) Diethylstilbestrol

D) Methylmercury

Explanation / Answer

C) Good laboratory practices (GLP)

in vivo toxicology studies are needed to authenticate the toxicological profiles of new drugs prior to administration to humans and to increase the acknowledged profiles of existing drugs.

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