Clinical research is emerging as a promising career of a branch of one of the medical science and one of the most knowledge-oriented industries, with rapid growth in India’s health sector. The Indian pharmaceutical industry is growing rapidly and has become a very favorite destination for global pharmaceutical companies to conduct their pharmaceutical research and development. As a result, India, which is considered as the second largest drug market in Asia, is becoming a center for clinical research. To open up new opportunities for the implementation of the General Agreement on Tariffs and Trade (GATT), India has to focus on the medical test market. Apart from this, there are several government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as an ideal for multi-centered clinical trials. Due to the spread of such a large variety of diseases like cancer and diabetes, India is seen as the ideal place for clinical research testing for the pharmaceutical industry.
The discovery process of clinical research drugs is an integral part of ensuring safety and efficacy of any new drug. It is the full biography of the medicine since its inception in the laboratory to introduce it to the consumer market and beyond. Clinical research is defined as the systematic and scientific study of the effects of exposure, risk, efficacy and a new medicinal product (medicine) that can be used for prevention, treatment, diagnosis or relief of a disease. can go. This clinical research determines the effect of safety and the effects of medicines, devices, diagnostic products and treatment therapies that are intended for human use.
Clinical research of new medicinal products is carried out through an organized clinical trial, for its release in the former market. To determine clinical trials, new biological or behavioral remedies are effective, effective and effective. These tests are conducted in 4 steps and are treated as a separate clinical trial at each stage of the drug approval process. The process of drug-development will normally proceed through all four phases for several years. The drug successfully passes through phase I, II, and III, it will be approved by the FDA (Food and Drug Administration) and then marketed for public use. Fourth phase ‘After approval’ are studying.
Before the pharmaceutical companies started clinical trials on a drug, they conducted a comprehensive pre-clinical study. In vitro (test tube or cell culture) and in vivo (experimental) experiments, the use of extensive dose of study medication involves the initial efficacy, toxicity and pharmacokinetic information. After this, the data obtained from the study of data are presented as an indigenous drug application for permission to study human. Then, it enters the clinical trial.
The main four phases in clinical trails include:
I phase tests: I have been made to assess Pharmacovigilance, Tolerance, Pharmacokinetics, and Pharmacodynamics of a drug. In the phase I tested, a new drug is administered by a doctor in a small number under the supervision of around 20-80 healthy, informed volunteers.
Second phase trials: Phase of the Phase II test works to assess how well the drug, as well as a large group of volunteers and patients, is designed to continue the safety assessment in the first phase. In the second phase testing, the drug has been administered to a group of about 100 – 300 inform patients will be able to determine the effects and also check for the unacceptable side.
Triple Phase Trials: Second stage tests are sometimes known as ‘pre-marketing phase’ which are aimed at ensuring that the assessment of the most expensive and time-consuming tests are done The effective drug is compared with the current ‘gold standard’, is the treatment. To analyze the results of using the company’s statistics, 3000 – The group is in the 1000s in this phase. If the results are favorable, then the data is presented for licensing of officers for a commercial license.
Fourth phase tests: Fourth phase tests include ongoing monitoring of security known as Postmarket Monitoring Trial (Pharmacovigilance) and getting permission to be sold after a medication. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
There is a very sensitive area for clinical research and is directly related to human life. This is an area which demands a scientific approach with quality, ethics, emotions and perfection. The future of medical science is in the hands of clinical research professionals and one mistake in this field can cost a lot for our future generations. So, who want to make a career in the field of clinical research, should be aware of their big responsibility.
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