The development of drugs involves a meticulous and coordinated process in which lead molecules are transformed into safer and more effective medicines. During this process, new medicines are ensured to comply with high standards and contribute to improved health outcomes through collaboration among researchers, practitioners, regulators and industry professionals. In the process of developing medicines, a number of stages are necessary to bring new medicinal products out of concept and into the market:-
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The journey at a glance
Identifying a potential target for drug development, often a specific molecule or biological pathway that is associated with certain diseases, is the first stage of this process.
Using a variety of instruments and techniques, including high-throughput screening as well as computing methods, researchers carry out large studies in order to gain an understanding of the objective.
When you have selected a possible target, you have to demonstrate that the target is involved in the process of progression of a particular disease and that the activity of the target molecule can be easily regulated.
This process involves identification of a compound which can interact with the selected target. Different screening experiments can be done to select the natural compound which can be re-purposed like drugs. Synthetic compounds can also be designed that can target the potential target and not interfere in other processes that takes place in the cells
Once lead compounds are found, they're optimized for safety and effectiveness. Modifications are made to prevent them from binding to unintended targets. Dosage and administration routes are tested on cell cultures before safety assessments in animals.
In order to evaluate safety, dosage, efficacy and side effects of the medicinal product in human subjects, this stage consists of three stages: Phase I, II and III clinical studies.
The initial phase of trials, involves less people generally <15. Phase I trial evaluates the safety and efficacy of new drug in healthy volunteers. Among all, approximately 70% drugs advance to phase II.
Determines a drug's toxicity, absorption, distribution, metabolism and excretion.
Phase II trials checks safety and efficacy. Participants usually have the targeted health conditions. It involves several hundred participants (200-500) who already have the condition the medication is designed to treat.
If Phase II results are promising, the medication may advance to Phase III trials.
It is final trial in which new medication is compared with existing treatment for some conditions. It involves large group, nearly 3000-5000 participants
Results usually provide package insert info (Prescribing Information for doctors, and Patient Information materials)
When results from the three phases of clinical trials are obtained and the drug has been appropriately formulated for a good safety and efficacy, it is forwarded for being reviewed by FDA (Food and Drug Administration).
When a drug is approved from USFDA, you have to register it in those countries where you want to sell it. All countries have different guidelines for registering drugs.
Any previously missed uncommon or long-term effects can be detected.
There are strict laws and regulations governing the drug development process. The Basic Law of the United States is a Federal Food, Drug and Cosmetic Act to ensure that medicines are safe and effective.
The process of drug development in India is governed by the new rules on drugs and clinical trials, published in 2019.
