Globalisation :
Globalisation Drug Discovery/ Pre-clinical Testing
Clinical Testing
Phase I
Phase II Safety and Efficacy
Phase III
Marketing Approval Process.
Pharmacovigilence
Drug Development Phases :
Drug Development Phases Drug Discovery/ Pre-clinical Testing Discovery
The process of drug development begins with the discovery of potential drug candidates. Pre-Clinical
Before a drug can be tested in humans, it must be tested for effectiveness in laboratory and animal studies. Animal studies are conducted to determine if there are any harmful effects of the drug and to help understand how the drug works.
Drug Development Phases :
Drug Development Phases Clinical Testing
Phase I
The primary goal of a Phase I trial is to determine the safety
of a drug. Conducted on Healthy Volunteers.
Phase II: Safety and Efficacy
After successful completion of the Phase I trial, the NDA will
proceed to larger Phase II trials to assess whether the drug
is effective in treating or preventing the targeted disease
or medical disorder
Drug Development Phases :
Drug Development Phases Phase III
In this trail drug’s safety and efficacy are verified in a large and varied
clinical population. Anywhere from hundreds to thousands of patients
participate in these studies that are conducted at multiple sites.
Marketing Approval Process
If the Phase III trials prove efficacy and safety, the company can then submit an application to the FDA to market the drug. This application must contain all the clinical data compiled during testing of the drug. Clinical Testing
Slide 6:
6 Pharmacovigilance:
Is also called as post marketing surveillance. This is on going process where adverse events are identified and monitored. Drug Development Phases
Questions? :
Questions?
Thank You :
Thank You