2. Step1:Discovery and development.
• Researchers discovered new drug through
• New insight into a disease process
• Existing treatments that have unanticipated effect
• New technologies
• Trial tests to find a possible beneficial effect
3. Thousands compounds are potential candidates but
Only small compounds call’s for further studies
4. Development
Researchers conducts experiments to gather information on;
• Absorption,distribution,metabolism and excretion
• Potential benefits and mechanisms of actions
• Best dosage
• Best way of administration
5. • Side effects
• Effects on different groups of people
• Interaction with other drugs and treatments
• It’s effectiveness compared to other drugs
6. Step2:Preclinical research
To establish whether it is toxic
There are two types of Preclinical trials;
1. Invitro
2. Invivo
Preclinical trials are not very large
They are detailed into dosing and toxicity
7. Step3:Clinical research
After review of findings in preclinical testing
Refers to trials done on people
Developers consider their accomplishments
For every different clinical research phases
Researchers begin Investigational New Drug process
8. Designing clinical trials
• Meant to answer specific research questions
• It follows a protocol
• The protocol is developed by researchers
• Before a preclinical trial begins,
• Researchers review prior information about drug
• Research questions and objectives are developed
9. Clinical research phase studies
Phase 1
• Study participants:20-100 healthy volunteers
-they can be people with diseases
• Length of study:several months
• Purpose:safety and dosage
• Approximately 70% move to next phase
10. Phase 2
• Study participants:upto 100 people
- they should have the disease
• Length of study:several months –2 years
• Purpose:efficacy and side effects
• 33% moves to the next phase
11. Phase 3
• Study participants:300-3000 volunteers
- they have the disease
• Length of study:1-4 years
• Purpose:-efficacy of the drug.
- monitoring their adverse reactions
12. Phase 4
• Study participants:several thousand volunteers
- the volunteers should have the disease
• Purpose:safety and efficacy
13. Step 4:FDA drug review
• If a drug developer has evidence
from preclinical and clinical trials that
a drug is safe and effective
for its use,the company file’s
application to market the drug
• FDA reviews their data for decisions
14. New drug application
• It demonstrates that a drug is
safe and effective for intended use
• Drug developers must include the following;
1. Preclinical data to phase 3 trials
2. Proposed labelling
3. Safety updates
15. 4. Drug abuse information
5. Patent information
6. Institutional review board compliance information
7. Directions for use
• For complete data presented,the review
team takes 6-10 months to approve it
16. FDA approval.
• Labeling accurately and objectively describes basis
for approval and how best to
use the drug
• Sometimes FDA requires the developer to
address questions based on existing data
17. Step5:FDA Post-Market Drug Safety Monitoring
• Even though clinical trials provide information
on drug efficacy and safety,
it is impossible to have a
complete information about the safety of
a drug at the approval time
18. • FDA reviews reports of problems with the
prescription and over-the-counter drugs
and decides to add cautions to
the usage information and other measures
• Other information incldes;
1. Supplemental application
19. 2. INDs for marketed drugs
3. Manufacturer inspections
4. Drug advertising
5. Generic drugs
5. Reporting problems
6. Active surveillance
