Drug Development Flashcards Preview

World of Chem > Drug Development > Flashcards

Flashcards in Drug Development Deck (16):
1

William Withering

Floxglove (Digoxin)

2

Highest Evidence

Meta-analysis and Systemic review

3

non scientific evidence ex.

youtube..

4

Case reports

Situation happen and share

5

2 types of animal trial

Interventional
Observational

6

Cross-sectionnal study

Observational on a single point in time
DO NOT PROVE CAUSE and EFFECT

7

Case-control study

Compare exposure on a risk factor
DO NOT PROVE CAUSE AND EFFECT

8

Cohort study

Prospective
retrospective

9

Randomized controlled double-blind trial

Experimental
Drugs research

10

T or F: Statistical difference is not the same thing than practical difference

True.

11

Meta-Analysis is

study of studies

12

How drugs goes to markets? steps

1. Idea
2. In vitro and Animal Trials
3. Investigational new drug application (Phase I,II,III)
4.New drugs application
5.Decision/review
6. Review data, labelling, facilities.
7. Phase 4.
8. Marketing/promotion

13

Accelerated approval for

Drugs for cure Cancer/ illness without cure or Tx.

14

Problems with clinical trials

Unforeseen risks
Unnecessary risks (drugs should be better than others)
Proper monitoring
Subjects' comprehension of trials
Financial

15

Drugs need to have the same bioavailability than the generic one, need to show that

the maximum concentration reach in the same amount of time than the generic one.

16

Orphan drugs

Very rare disease
Gouv. finance