parma- cont FDA

Question 1

what I mean by (FDA) ?

Answer 1

it is United States, the Food and Drug Administratio

Question 2

FDA requires that all
approved drugs fulfill two requirements

Answer 2

1- effective against the disease

2- drug must meet safety criteria

Question 3

what I mean by safety criteria ?

Answer 3

being subject to:

1- animal testing ( Pre-clinical trails)

2- controlled human
testing (Clinical Trails)

Question 4

Gaining FDA approval usually takes ?

Answer 4

several years ,,, from 6-12 year

Question 5

Testing done on animals must be ……

Answer 5

1- extensive

2- include several species

Question 6

why the animal testing must be
extensive and include several species ??

Answer 6

to help me to evaluation effectiveness and safety of a drug

Question 7

what is the expensive and lengthy 6-12 years

Answer 7

Drug Development

Question 8

Drug Approval Process requires 2 principle steps ?

Answer 8

1- Pre-clinical trails = on cell and animals

2- Clinical Trails= on humans

Question 9

in Clinical Trails we have 4 phases , what are they?

Answer 9

1-3rd phases = done before drug is marketed

4th phase = post marketing phase

Question 10

the Clinical Trails may take in 4 phase alone ……

Answer 10

2-10 year

Question 11

we can have the FDA approval in which phases??

Answer 11

in phase 3 or 4

Question 12

the phase that we tend to do Clinical Trails - post marketing is-

Answer 12

phase No. 4

Question 13

pre-Clinical Trails done to

Answer 13

cell and animals

Question 14

Clinical Trails done to

Answer 14

human

Question 15

which is first in approval steps

Answer 15

pre-Clinical Trails