Terms from drugs

Question 1

The Drug Approval Process

Answer 1

The drug is developed and has to seek FDA approval for sale in the US

PRE CLINICAL
1) Animal testing
new drugs are tested on animals to identify toxicity
gather basic info on efficacy

2) IND Application
must submit a IND application to the FDA based on the results from the initial testing that includes the drugs composition and plans for human testing

CLINICAL
3) Phase 1
20-80 healthy volunteers used in phase one-emphasizes safety-determines the most frequent side effects

4) Phase 2
100s the typical number of patients-to deterime effectivness-tested on people with the drug

at the end of phase 2 the FDA and sponsors discuss how large scale studies in Phase 3 will be done

5) Phase 3
1000s of patients used to gather more information and determine effectiveness and dosages

NDA Review
6) there is a review meeting
7) The is NDA aplication for the marketing of the drug
8-9) the app is reviewed
10) drug is labelled with accurate info
11) there is a facility inspection
12) drug is FDA approved

Phase 4-post marketing to monitor safety issues after the drug is release

Question 2

Average cost

Answer 2

2.3 billion

Question 3

Average time

Answer 3

12-15 years

Question 4

in vitro

Answer 4

means research done in a laboratory dish or test tube

Question 5

in vivo

Answer 5

means research done on a living organism

Question 6

What is the modern discovery method for drugs?

Answer 6

identify disease
then find drugs to treat the disease

before they would have the drug but didnt know which disease it treated

Question 7

Methods of finding new drugs

Answer 7

a) extraction from natural sources
b)modifications to existing drugs
c) computer based methods
d) combinaitonal chemistry and high throughout screening

Question 8

Structure-activity relationship

Answer 8

are used to make better compounds from those identified serendipitously or by purposeful searching-modifying and improving existing drugs may speed up the drug discovery process

evaluate the effects of structural changes on drug activity

Question 9

structure guided drug design

Answer 9

computational chem software is used to design molec that could bind to a specific target of a known structure

3D images are oftained by x-ray crystalography

Question 10

Combinatorial chem

Answer 10

allows the syntehsis of large libaries of compounds-split and mix synthesis

makes like all combinations of proteins

but just bc it works in a test tude doesnt mean it wil work in the body

Question 11

Photodynamic therapy

Answer 11

drug inserted then the area is irradiated with light of the correct wavelength