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Steps that the pharmaceutical companies develop their products before the are made available for public
Drug development
A process begin after experts/scientists identify a molecule targets (cell receptors, enzymes,…) that can be dysfunctional and cause disease and then discover new compounds that may have beneficial effects
Discovery
What is NME?
New molecular entity
The process after the NMEs is identified they will be conducted experiments → mechanism of action. potential benefits, effectiveness, dosage, route off administration,…
Development
What is FDA
In vitro
In vivo
What is IND
Investigational New Drug
The process of testing an NME through in vitro and in vivo studies → Safety and Toxicity before using in human. Researchers then analyse the results and submit IND to the FDA.
Preclinical research
The process after the FDA approves and IND submitted by a sponsor clinical trials can begin.
Clinical research