The drug development process requires more money and lots of time. In case all the development process is in straight forward, then it takes only seven years. But normally the drug development process takes a minimum of twelve years. The procedures and regulations are strictly followed to make the safety and also produce an effective drug. Many of the compounds are rejected on the preclinical research phase itself. Clinical trials are done by using animal or in vitro studies. However many medicines are withdrawn and not accepted as a medicine because of their side effects, less effective and high cost.
Steps to be involved in drug development phases
Step 1: Discover the drug and their validation
The first step of drug development is to find out the target. The drug development companies first choose the molecules like gene or protein to target with the drug. The drug developer will confirm that this molecule should be suitable to produce the drug for the targeted disease. After undergoes multiple testing, the molecule will be finalized to produce the drug.
Step 2: Preclinical testing or preclinical research
The second step is preclinical research. This preclinical testing is divided into two subcomponents: in vitro and in vivo testing.
- In vitro testing: This testing examines the drug molecules interacting in the test tube and also takes place within the lab settings.
- In vivo testing: In this method, the molecules testing on the animal model and other living cell culture.
Step 3: New drug application filling
The 3rd step is to submit the investigational new drug application to the FDA before starts the clinical trials. The FDA will analyze the side effects, safety procedure, drugs chemical structures, etc. If FDA approves then start the human trials.
Step 4: Clinical studies – Phase 1
In this stage, the drug is tested with a small group of healthy people. This will help to analyze how the medicine will absorb and eliminated by the body, any side effects are caused or not.
Step 5: Clinical studies – Phase 2
In this clinical study, the drugs are tested with lots of disease persons, whether it will cure the disease or may cause any other issues on the body. Safety is the main thing in this phase 2.
Step 6: Clinical studies – Phase 3
In this phase 3, efficiency plays a major role. This phase is designed by the drug developers but approved by the FDA based on the complete guidance of the regulations whether the drug get success or failure. This is the longest process and also requires more money.
Step 7: New drug application filling
The seventh step is the simple step of filling the application for the new drug to the FDA. This will takes 10 more months to analyze that the drug is suitable to the people without causing any side effects. This is the final stage that the FDA will approve the medicine and give certification that it is eligible to use.
Step 8: PDUFA date and decision
FDA will wait until the PDUFA date to release the decision. If the FDA gives approval, then immediately the drug comes to the commercial uses.
Step 9: Clinical studies – Phase 4
After the drug comes to the commercial uses, the drug developers should submit the regular report to the FDA and analyze the effects of the drug for some more time.
These are the steps involved in the preclinical research and development of the new drugs.