Bioequivalence Studies

Bioequivalence (BE) studies are a crucial requirement that must be fulfilled by pharmaceutical companies for their newly formulated drugs. BE study reports are mandatory for local and international distribution of drugs as per the guidelines of the National Medicines Regulatory Authority Sri Lanka (NMRA). Until recently, all pharmaceutical companies established in the country completed their BE requirement by outsourcing them to other countries and it is a costly and inconvenient process.

As a leading university in Sri Lanka, KDU has identified the capacity and capability of performing BE studies to cater to the BE study requests within the country. So far, multiple BE study projects have been successfully completed by KDU, gaining much attention among the pharmaceutical companies in the island. KDU is receiving multiple BE requests daily and recently two MOUs were signed with the Navesta Pharmaceutical company for two drugs. Currently, the Institute of Combinatorial Advanced Research and Education (KDU-CARE) has the advanced analytical instrumentation and human resources to carry out the BE studies together with the clinical support from the Faculty of Medicine (FOM-KDU) and the University Hospital (UHKDU).

To date, there are no centers for BE studies equipped with essential laboratory facilities and accreditations in Sri Lanka. KDU is diligently working on expanding the current BE facility at KDU-CARE to a National Center for Bioequivalence Studies (NCBS-KDU) and to obtain all required WHO (World Health Organization) accreditations to efficiently full fill the BE requirement within the country and overseas. Further, the continuous collaborative support from the International Center for Chemical and Biological Sciences (ICCBS) Karachi, Pakistan, led by Professor Iqbal Choudhary will be taken for all training and technical guidance to the establishment of the NCBS-KDU.