DOI: 10.21276/ajptr
Fri, 24 May 2019

Consecrate to Population Suffering From Life Threatening Diseases: A Regulatory Perspective to Biomarker and Surrogate Endpoint

Akash J. Dave*, Valluru Ravi, Balamuralidhara V., Pramod Kumar TM., Venkatesh MP.


1. Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University,Mysore-570015, Karnataka, India. 571422, India

Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are substituting the clinical trials and decrease the duration of product development phase as well as decrease the entry time period of novel products in the market. The article enlightens the extent to which the biomarkers and surrogate endpoint have benefited the pharma industry for expediting the entry of their products into the market at the earliest to get the maximum benefit of the product during the patent period. Simultaneously article also throws light on the history of risk factors of surrogate endpoint which are likely to jeopardize the interest of the human beings involved. It may conclude that Biomarkers and surrogate endpoints play pivotal role in accelerating approval process for drug approval in USA and the usage of these parameters to minimize the casualty of human lives who are suffering from serious life threatening diseases by providing recent research products which have caliber to cure or improving the quality of life.

Key words: Clinical trial, Biomarker, Surrogate end point, Accelerated approval, Caliber to cure, Casualty of human lives.

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