Pharmaceutical companies serve to discover, patent and market medications and medical apparatus. They are permitted to research substances via experiments that can prove to be curative or preventive. Once a breakthrough discovery is made, the developing product is tested regarding its safety, efficacy is measured and tested, both on individual basis and comparative to similar drugs. After a series of processes, the final product is allowed by the Food and Development Authority (FDA) to be marketed.
In the past, drugs were made by extracting the curative material from natural substances. The decision of which substance was most efficacious was based on trial and error, leading to many human casualties. Scientists now have discovered a much safer method of developing drugs. Researchers belonging to the pharmaceutical industry study diseases, their pathogenesis and effects in great detail to discover substances that may inhibit or reverse one or more steps involved in disease development. The use of knowledge obtained from molecular biology and biochemistry, and supported by the latest techniques as given by biotechnology helps manipulate disease progression, giving impressive results.
This refers to the next step after a substance has been discovered that can inhibit or block a critical step in the development of a disease. It includes testing the substance until it is proved to possess the qualities of a potent, efficacious and safe medication. Objectives include the formulation and dosing of the substance at which the most competent effects can be elicited. This is done by both in vivo and in vitro laboratory testing and clinical trials. The trials can be performed by the company itself or be performed by universities and various contracted research societies.
Product approval lies with the FDA in the United States. Once a pharmaceutical company discovers a potential medication, it should be filed to the FDA as a Investigational New Drug (IND). There should be sufficient pre-clinical data to allow the company to proceed to human testing and trials. If IND is approved by the FDA, a series of procedures constituting three basic phases is started.
- Phase I:
It is primarily about testing the toxicity of the drug and its reactions and cross reactions with different substances.
- Phase II:
It is about studying in detail the pharmacokinetics and dosage of the drug.
- Phase III:
In phase III, an intended population for the usage of the drug is decided and the efficacy of the drug is tested on that population.
If positive results are obtained, a new application, called the New Drug Application is submitted to the FDA. It contains details of experiments performed in the three phases and their results. It is reviewed by the FDA, and if the FDA decides that the product has a positive benefit-risk assessment, it is approved to be marketed by the pharmaceutical company.