Clinical Implementation of Pharmacological Principles

Question 1

Food and drug act of ____: provides legal definitions of drug and prohibited interstate commerce in misbranded and adulterated food, drink, and drugs

Answer 1

1906

Question 2

The food and drug act of 1906 did not prohibited ___ ___ claims but only false and misleading statements about ingredients or identity of a drug. You can claim that your drug cures cancer as long as you list all the ingredients

Answer 2

False therapeutic

Question 3

6 gallons of _____ _ _____ we’re not retrieved and consumed, causing 107 deaths. This lead to the Food Drug and Cosmetic act of ___ which requires that drugs be shown to be safe prior to approval

Answer 3

Elixir of sulfanilamide
1938

Question 4

In Europe, the drug ____, was used for morning sickness but the FDA never approved it. The _______ ____ of 1962 requires that the drug manufacturers prove drug efficacy prior to FDA approval

Answer 4

Thalidomide
Kefauver-Harris Amendment

Question 5

____ ____ is when the drug is first discovered, understanding the mechanisms and identifying molecules

Answer 5

Preclinical trials

Question 6

___ ___ is performed after preclinical trials to help determine efficacy and adverse effects

Answer 6

Animal testing

Question 7

After preclinical trials and animal testing, a ____ ___ ____ application is bright to the FDA for approval before moving into clinical trials

Answer 7

Investigational New Drug (IND)

Question 8

Phase 1 clinical trial: is very ___ scale, goal is to determine safety. Healthy individuals are used

Answer 8

Small

Question 9

Phase II clinical trial is to determine ___ and ____. Affected individuals are used and helps determine clinical dosing

Answer 9

Efficacy and safety

Question 10

Phase III clinical trial is ___ scale trial. It is. Multi center ___ ___ placebo controlled cross over study

Answer 10

Large
Double blind

Question 11

In 1997, clinical evaluation of ___ differences. Sex does matter and all genders should be included in trials

Answer 11

Gender

Question 12

___ ___ requires IND holders to tabulate in their annual report the number of participants enrolled in clinical trials by age, race, gender and requires sponsors of NDA to include summaries of effectiveness for important demographic subgroups

Answer 12

Demographic rule

Question 13

A ___ ___ application requires FDA advisory panel recommendations and agency approval. It needs appropriate labeling indications and adverse effects

Answer 13

New Drug (NDA)

Question 14

There must be ____ ___ when a new drug comes out. ___ ___ is an adverse event reporting system. This are phase ___ clinical trials

Answer 14

Post-marketing surveillance
Med watch

Question 15

Know these equations:

Answer 15