This is a question that many of us, patients or family members of people with rare diseases in particular, ask ourselves constantly. We are often faced with news about research or the launch of new therapies, but we do not understand the process between the developments of a new drug until it arrives for the patient. The purpose of this text is to inform so that everyone can better understand how the development process happens, until the medication arrives for the patient.
Yes, there are steps to follow
Initially, you need to know that every drug that is going to be launched on the market goes through several stages of research and testing until it is approved by the competent body in the manufacturer’s country of origin. After a proper Drug Post Launch Activity, a medicine is announced safe for the use. Drug post launch activity ensures the benefits/risks of the drug. In this process the company track, report, and evaluate the result.
What is the first step?
The first step necessary for a drug to exist is its discovery. Not all discoveries become drugs. There are thousands of researches underway in the world, and countless researchers without incentive to develop their research. The process of regulating a drug is long, rigorous and very expensive for the pharmaceutical industry. It must comply with several steps.
This step has the objective of verifying if the drug candidate substance is effective and safe, besides analyzing how the new substance is absorbed by the body, how it is eliminated and its safety. Generally, the preclinical study is carried out first in vitro and later in vivo. After the animal stage, clinical studies are scientific research involving human beings and aim to evaluate the safety and efficacy of a test procedure or medication through data collection. It is the systematic study that follows scientific methods applicable to human beings, called research volunteers.
Three phases of clinical research
Phase 1: First investigation into the potential of a new drug in humans, to determine how the drug reacts in the body.
Phase 2: Focuses on the clinical effectiveness of the drug. The study also assesses short-term adverse effects and risks related to the safety of the drug.
Phase 3: Drug Post Launch Activity carried out in a large number of patients, comparing the medication with the best existing treatment or standard of treatment of the disease.