A word about the Drug Development Process

The heart of all the stages a drug undergoes is the drug development process. Within the drug development process lies a description of each and every step that goes into the development of the drug. The FDA describes five steps that the drug development process has to undergo:

One:The drug's discovery and development

Two:Preclinical research

Three:Clinical research

Four:FDA review

Five:Post Market safety monitoring by the FDA

Stage One:This stage is when the discovery and development that leads to the drug development process of the drug takes place. Innumerable compounds are tested for their ability to get developed into a drug at this stage. Scientists and researchers carry out this stage of the drug development and select a few of these for further study. Protocols of the selected compound are put in place to identify its viability for getting developed into a drug. Core aspects that go into this stage include the manner of its absorption and distribution in the body, side effects, the proper form and dosage, its reaction in varied demographic clusters such as gender, age, race and so on.

Stage Two:In vitro and in vivo tests are carried out at this stage for setting the requirements of the drug for complying with Good Laboratory Practices (GLP) and determining whether it does or not. An important reason for this stage of drug development process is that it offers information on critical aspects such as toxicity of the drug. These results lead scientists to determine if the drug can be, or has to be tested on humans.

Stage Three:Drug development process at this stage is done to decide the precise manner in which the drug needs to be tested on humans, and makes way for the investigational new drug process (IND).

Stage Four:Following the IND process; the drug has to start the New Drug Application (NDA) process. The NDA, which is the complete history of the drug from the earliest stage, opens up the drug for FDA approval. The FDA approval is the final benchmark that the drug needs if it is to be marketed. This is a very lengthy process and, depending on the type of drug, can take years.

Stage Five:Although this is formally the point at which the FDA approves the drug for marketing; the drug development process goes on. The FDA monitors the product much after its entry into the market.

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