Before entering patients' hands, a drug or medicine must pass many quality checks. Pharmaceutical companies are required to ensure the safety of the drugs through animal and laboratory tests. According to internet-based research, each year, thousands of companies try to make a license to become pharmaceutical companies.
Drug discovery and development are a long history starting in the early days of human civilisation. In ancient times, drugs were usually made from plants and are also considered an important religious and spiritual aspect. Hippocrates Lacks has contributed a lot to the pharmaceutical industry. He wrote more than 70 books in which he explained many different diseases and their treatment process. Hence, he is also known as the father of medicine. In ancient times, European countries used traditional medicines or drugs to treat patients suffering from various disorders. From around the 18th century, the pharmaceutical industry started developing. In 1669 Merck in Germany was the first pharmaceutical company. And in 1827, Merck started its expansion and production according to the requirements of the world.
The Process of Drug Development
A pharmaceutical company must go through several stages to make its products safe and approved by the authorities. Are you aware that a new drug or medicine takes approximately 12-15 years to get approved in the US? 12-15 years is one-third of a complete professional career in pharmacy. Many drugs are made to treat patients suffering from various diseases or disorders. The drugs or medicines must pass through various stages to get approved. The following are the phases of drug development-
- Drug Discovery and Development- It is the most important and first phase of drug development. Researchers try to develop a new drug with the help of insights into disease and by using the new technologies. To develop or create a new drug, researchers must test many molecular compounds to find the most suitable and safe compound to help doctors give effective treatment to their patients. After finding the most suitable compound, researchers must conduct different types of experiments to gather more information about the compound. For example- The advantages and disadvantages of the compound, the best dosage and the best way to give the drug to the patients (mouth or injection), how it will interact with the body of a patient, etc.
- Preclinical Research- The best drug researchers say that before testing the drug in a human body, they must find out all the possible advantages and disadvantages of the drug in a human body. The researchers are required to check all the toxicity of a new drug. There are two preclinical research, i.e., In Vitro and In Vivo. FDA (Food and Drug Authority) asks researchers to use trusted laboratory practices for preclinical research. It is said that preclinical research must give detailed information about the disadvantages or toxicity of a drug.
- Clinical Research- Preclinical research answers the basic questions about the drug's safety, and clinical research is considered the opposite. Clinical research is regarded as the trial of medicine done in humans and to analyse of the drug's reactions. Through clinical research, researchers check whether they are getting the expected results from the drug or not. If they didn't get the desired results, they analyse what changes they can make to a drug to get the best results. The phase of clinical research starts with the IND process (Investigational New Drug). It is a process in which the researchers are required to submit an application form to the FDA to begin their clinical research.
- FDA (Food and Drug Administration) Review- After getting the safety reports of a drug from the researchers, the FDA authority examines the report and drug and makes decisions on whether they have to approve the drug or not. In the drug report, a developer must include all the data, study, analyses, research, and clinical research report.
- FDA Post-Market Drug Safety Monitoring- Even after all the research and the safety report, it is impossible to have complete safety information about a drug.FDA authorities say that a clear picture of drugs comes after the years. Therefore, FDA asks developers of the drugs to add dosage information to their products.
The above mentioned are the drug development process followed by the developers to approve their medicines. Scientists and Researchers in the world are trying very hard to increase the development of pharmaceutical companies and to deliver safe drugs to patients so that they can recover from their diseases and injuries.
Medical Science is defined as the science of treating and preventing living organisms from various kinds of injuries and diseases. Millions of students all over the world are pursuing a degree in medical science. While studying medical science, students face many different types of challenges in completing their complex assignments and in maintaining their academic scores. Are you also a medical science student suffering from the same problem or stress? If yes, you can take help with assignments from the best industry experts. The best medical science assignment help providers assist students in completing their assignments on time and in an error-free manner. It is said that they also provide essay writing services to university students. By taking essay and assignment writing services from experienced helpers, students can also grab a chance to enhance their subject knowledge and academic scores.
References
https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring
https://tedorpharma.com/news-posts/what-are-the-four-stages-of-drug-development/
https://www.biospectrumindia.com/views/70/20766/evolution-and-developments-in-pharma-industry.html
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