Drug Development Process

List the following stages in the correct order as they relate to the process of drug development:

Post-marketing surveillance, government/FDA review, drug discovery and development, preclinical research and clinical research.

Drug discovery & development —> Preclinical —> Clinical —> Government/FDA review —> Post marketing safety studies

which phase is established safety and dosing

20-100 people

phase 1

what phase is side effects and efficacy

up to several hundreds of people

phase 2

what phase is confirm efficacy & safety

300 to 3000 people who have the disease

phase 3

provides earlier approval of certain drugs and is used for

• For drugs for serious health conditions 

• For conditions for which there is unmet medical need 

• Approval is based on surrogate endpoint 

• Phase 4 studies (post marketing studies) are still required after market approval. If there is no confirmation of efficacy and safety, drug can be removed from the market 

accelerated approval program

biomarker that is to predict clinical benefit but is not itself a measure of clinical benefit is what

surrogate endpoint

when is IND submitted

after stage 2

when is NDA submitted

after stage 3

• Confirms safety in larger population after long term

• Months- years 

• Several thousands people who have the disease

What phase?

phase 4

when is FDA accelerated approval program happen

after phase 4 study will be perform

Which of the following phases occurs in humans after an Investigational New Drug (IND) approval but before FDA approval?

phase 1,2,3