The Drug development process starts with the target identification followed by the Pre clinical studies, First in Man, then trials in patients for efficacy followed by large scale trials in various sets of patient population till the same reaches the approval stage followed by the post marketing surveillance studies. As the drug development stage starts, higher is the uncertainty and lesser is the reliability of the clinical trial results of the stage under study of a drug to succeed. A substantial amount of time and investment is spent by drug companies carrying out experiments of high risk and known and unknown side effects. Till the drug’s safety profile has been established, the stage of clinical trials in patients i.e. Phase II always remains under a “”lacunae””. If the drug safety profile has been established successfully in healthy volunteers, the efficacy of the drug can be established in patients only in the second phase. Once the drug reaches its efficacy mark in a patient population in Phase II, only then it proceeds to Phase III trials only.
The Phase III trials are conducted in large patient populations across the world and are conducted to establish and prove efficacy and safety in all types of population over a substantial period of time. Once this stage is accomplished, it can be safely established that the drug is ready to file for approval for marketing. The drug if approved by the regulatory authority of interest has to be finally tested by the manufacturing company for post marketing surveillance. The drug enjoys a patent exclusivity for some years (varies from drug to drug) before it goes off patent. Once the drug is off patent, other manufacturers can make off patent/ copy cat versions/ generic drugs after the loss of patent exclusivity.
Generics once proven bio equivalent to the original drug after conducting Bio –equivalence studies can be made available for marketing in the country of interest.
Bio equivalence studies are outsourced to CRO’s. Indian CRO’s conduct a large number of Bio equivalence studies.
Veeda Clinical Research is an Indian CRO based in Ahmedabad which provides cost effective Bio-Equivalence studies for the drug industry.