What is Step 1 in the drug development process
Discovery and Development
What are some of the things studied in the step 1 phase
- How is a compound absorbed, metabolized, and excreted
- Potential benefits and MOA
- Best dosage
- Best way to give the drug
- Drug interactions
- Effectiveness compared to other drugs
What is Step 2 in the drug development process
Preclinical research
What are the two types of preclinical research
In vitro, in vivo
Data from which step in the drug development process will allow researchers to move on with human trials
Step 2: Preclinical research
What is Step 3 in the drug development process
Clinical Research
What does IND stand for?
Investigational new drug process. This is the stage before human trials are allowed to begin
What are some of the things to consider when designing a study protocol?
- Who qualifies to participate
- How long will it last
- How many participants
- Whether there is a control group or what mechanisms are in place for limiting research bias
- What assessments will be conducted, when, and what data will be collected
- How the data will be reviewed and analyzed
What are the components of an IND application to the FDA?
- Animal study data and toxicity
- Manufacturing information
- Clinical protocols (study plans)
- Data from any prior human research
What is the purpose of Phase 1 trials
Safety and dosage
Generally how many participants are in phase 1 trials
20 - 100 healthy volunteers with the disease or condition
What is the duration of Phase 1
Several months
What is the purpose of Phase 2 trials
Efficacy and side effects. Typically trials isn’t large enough to determine efficacy, but will help to design phase 3 and establish a safety dosages
How many participate in Phase 2
Up to several hundred
What is the purpose of Phase 3
Efficacy and monitoring of side effects
How many participate in Phase 3
300 to 3000
What is the duration of Phase 3
1 - 4 years
What is the purpose of Phase 4
Safety and efficacy
What is the FDA application after an IND
NDA. This will tell the full story of the drug and allow the manufacturer to market it. Once FDA approves, it will work with manufacturer on the labeling process
Do generic drugs go through the same process as the initial sponsor?
No, they just need to conduct bio-equivalence studies and file a New Drug Application
