Research on different aspects of diseases is always a continuous process that results in developing new drugs to improve medication. To do that, pharmaceutical companies conduct a drug process development which entails transforming a potential drug compound into a final product approved by the authorities for human use and sale. The process entails numerous and rigorous stages to get an end product that's effective, safe, and economically viable. Below is an overview of the steps involved in drug process development.
Drug Discovery Research and Development
This process involves how compounds are discovered and developed into potential drug candidates for treating a particular disease. At the discovery stage, researchers study various molecular compounds and narrow them down to one that stops or minimizes the virulence of a particular disease. They conduct further experiments at the development stage to gather detailed information on the drug. For instance, the results show potential absorption and utilization methods, dosage, reaction to other medications and diseases, and the effect on different groups of people, e.g., age and race.
Pre-clinical research involves testing the drug's efficacy on non-human subjects to determine its toxicity before trying it on a person. That is done via in vivo, ex vivo, and in vitro experiments. In vivo experiments are conducted on animals such as dogs, rats, and mice. Ex vivo experiments are done on animal cells and tissues from a dead animal. In vitro test uses chemical compounds in the laboratory. The results from the pre-clinical test will determine whether to proceed and conduct the experiments on humans.
Clinical Drug Development Process
Clinical research entails testing the drugs on humans, and it's the only way to determine exactly how the medicine will behave in a person's body. Clinical trials take time because discovering a drug's effects is lengthy as they uniquely affect different groups of people. Also, finding people willing to participate in the trial takes time. This stage may start with a small group of healthy people volunteering and then advance to studies in a patient population.
Review and Approval by Authorities
After the clinical research tests find the drug fit for use, it is then taken to the drug regulatory authority for an independent quality assurance test for your company to get approval to sell the drug. The regulatory authority will grant or deny approval based on the drug's toxicity, performance level compared to existing medications, and depth of research and information. Once the drug is approved, you can then distribute and sell it. The regulatory authority will also conduct post-market safety surveillance to gather consumer and expert reports.
Choosing the right pharmaceutical company for drug process development services is important for an effective process that will comply with regulations and develop a safe drug. Consult the services of a reliable pharmaceutical company for more information on drug process development services and get your drugs approved.Share