Question

Hi there I am looking for some help with my toxicology study guide questions

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

Answer 1

1.C) elixir sulfanilamide

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

3. B) Phase I trial

4.C) test the effects of the drug in a patient population.

5.E) Phase IV

6.A) genotoxicity