Drug discovery and development is already a complex process but do you know that over the preceding 4 decades, the intricacy of drug development has multiplied even more? Yes, you heard it right! This has further necessitated the preclinical stage of drug research, an investigational new drug (IND) application, and extensive clinical testing prior to FDA marketing clearance.
You need to remember that before being approved, new drug applications (NDAs) or biologics license applications (BLAs) are typically thoroughly reviewed. And, following approval, drug effectiveness is then once again forwarded to regulatory organizations for post-marketing research.
You need to keep in mind that the main objective is to provide patients with safer, more effective treatments as soon as possible following a careful medical review.
Drug Discovery and Development: How Many Stages Are There?
As we are talking about drug discovery and development, you need to remember that it comprises 5 important stages. Yes, that’s correct! And, those 5 stages include:
- Discovery and Development of Drug
- Performing Preclinical Research
- Clinical Development
- Review By The FDA
- Post-Market Safety Monitoring by the FDA
Drug Discovery and Development: A More Detailed Study of Each Stage
Now that you are aware of the different stages and processes of drug discovery and development, let us have a more detailed understanding of each stage.
Discovery And Development of Drug
New drugs are developed through drug discovery research. Drug research, formulation, and development traditionally began with the identification of active components in conventional medicines or just by chance.
Present-day drug research and development procedures include screening findings, iterative pharmaceutical applications, and refinement of hits to lessen possible side effects.
Performing Preclinical Research
The preclinical stage of drug development starts with in-vivo investigation to ascertain the drug’s safety and effectiveness after a lead chemical is discovered. Remember that the preclinical CRO researchers explore the following facts concerning the medication:
- Information about ingestion, dispersion, metabolization, and disposal.
- Potential advantages and functional properties.
- Optimal dosage and method of administration.
- Undesirable incidents or side effects.
- Impact on specific racial, ethnic, or gender groupings.
- Interactions with additional therapies.
- Efficacy in comparison to comparable medications.
Clinical Development
Following the conclusion of preclinical research, scientists proceed to clinical drug development, which involves human participant studies and clinical trials to optimize the medicine for use in patients. Trials conducted during this period may be impacted by the intricacy of clinical trial layout, its associated expenses, and implementation challenges.
In order to ensure that the drug is as effective as feasible for its intended use, experiments must be both safe and effective.
Review By The FDA
The FDA advances a new medicine for comprehensive assessment once it has been developed for maximum safety and effectiveness and the findings of clinical trials are accessible. Remember that at this stage, the FDA examines the medicine application that the pharmaceutical company has submitted and decides whether to permit it or not.
Post-Market Safety Monitoring by the FDA
The FDA mandates that pharmaceutical firms use the FDA Adverse Event Reporting System (FAERS) repository to track the safety of their drugs once they have been manufactured and approved. FAERS supports FDA’s post-marketing security surveillance program implementation.
Remember that manufacturers, medical experts, and patients can all report issues with licensed medications using this service.
The Bottom Line
All in all, we can say that indeed the development and discovery process of drugs is quite complex. And, each step needs to be performed the right way to ensure the safety and security of the potential users. So, it’s recommended that you take help from a good drug discovery company for good results.
