When a drug enters the market, all we think about is how effective it is going to be and some might think of it in terms of commercial success. However, how many of us think of what goes into a drug in development?
Drug in development is an umbrella term that involves several stages and lengthy steps that aid in bringing a new drug to the market. This involves steps like product development, clinical trials and pre-clinical research. In terms of strategies for commercialization, this process has a great effect on drug developments. A lot of these processes are spent in focusing on adhering to regulations put forth by licensing authorities. The aim behind this process is to analyze the parameters of new elements that result from the procedure. Before performing the human clinical trials, this process could help in determining the safety, effectiveness of the drug and toxicity.
Another important aim of drug in development is to determine the appropriate dosage of the new drug for the first intake by a human. During this process, it is important to determine things like stability and solubility of the drug, chemical makeup, and suitability of the product to be fit into aerosol, tablets, capsules or intravenous substances. This entire process is termed as Chemistry, Manufacturing and Control or CMC. It comes under pre-clinical development.
After the results of clinical trials are established, the process of drug in development also focuses on factors like chronic or long-term toxicities due to the new chemical compounds as well as the effects it has on functions of human body such as the immune system, reproductive system and fertility. The compounds are also tested for its relation with causing cancer.
Drug development process is not only a lengthy and painstaking process but it is also a costly affair. And the labor and elaborate process involved contributes to a large extent to the rising cost.
