drug development & clinical testing

Question 1

is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery

Answer 1

Drug Development

Question 2

phase wherein

Determine drug effectiveness, efficacy and safety dosage

Answer 2

Pre-clinical testing

Question 3

Subjects of Pre-clinical testing:

Answer 3

• Microorganisms
• Laboratory Animals (hamster, mice, rabbit, cat, monkey, ape)

Question 4

Time period of Pre-clinical testing:

Answer 4

1-2 years period

Question 5

phase wherein

Determine the drug effects, safe dosage & pharmaco-kinetics

Answer 5

Phase 1 Clinical Testing (Humans)

Question 6

Subjects of Phase 1 clinical testing:

Answer 6

Small # of healthy HUMAN volunteers

Question 7

Time period of Phase 1 clinical testing:

Answer 7

less than 1 year

Question 8

phase wherein

Assess drug effectiveness in treating a specific disease or disorder

Answer 8

Phase 2 Clinical Testing

Question 9

Subjects of Phase 2 clinical testing:

Answer 9

200–300 patients with target diseases or disorders

(co-morbidity → DM, HPN,COPD, allergy)

Question 10

Time period of Phase 2 Clinical testing:

Answer 10

2 years period

Question 11

phase wherein

Assess drug effectiveness and safety in a larger disease or disorder population

Answer 11

Phase 3 Clinical Testing

Question 12

Subjects of Phase 3 Clinical testing:

Answer 12

1,000–3,000 patients with target diseases or disorders

(co-morbidities)

Question 13

Time period of Phase 3 Clinical testing:

Answer 13

3 years period

Question 14

Phase wherein:

Monitor any problems that occurs after NDA approval

Answer 14

Phase 4 Clinical testing

(post marketing surveillance)

Question 15

Subjects of Phase 4 clinical testing:

Answer 15

General population with target disease or disorder

Question 16

Time period of Phase 4 clinical testing:

Answer 16

Indefinite

Question 17

The entire process to approved vaccine or drug typically takes more than a ______

Answer 17

Decade (10 years timeline)

Question 18

Phases in Investigational New Drugs (IND) Application

Answer 18

Phase 1

Phase 2

Phase 3

Question 19

Phase where drug is approved (New Drug Application (NDA) Approval) :

Answer 19

Phase 4