Bioavailability and Bioequivalence

Clinical Trials

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behaviour, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. Preclinical trials are early experiments performed in the lab, prior to being tested in humans. This early research helps to identify potential treatments that are unsafe or ineffective. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

The market of clinical trials in India is predicted to reach at a CAGR of nearly 36% between 2006–2011 to gain revenues worth US $ 546 Million in future. The Prime advantage of conducting clinical trials in India is the availability of a huge patient pool that can be initiated at much lower time then it takes to recruit patients in the west.