The Hindu : Human pharmacology unit opened

Online edition of India's National Newspaper
Monday, Jan 19, 2004

Karnataka

Karnataka - Bangalore

Human pharmacology unit opened

By Our Staff Reporter

BANGALORE, JAN. 1 8. Clinigene International Pvt. Ltd., a subsidiary of Biocon Ltd., has launched a state-of-the-art human pharmacology unit at the Sagar Apollo Hospital here.

The Biocon Chairperson and Managing Director, Kiran Mazumdar Shaw, on Friday inaugurated the unit to conduct world class cost-effective Phase I clinical trials on volunteers.

Ms. Shaw said the unit was also equipped to conduct studies on bioavailability and bioequivalence on volunteers.

It could accommodate 26 volunteers at a time. It had facilities for screening, counselling, blood sampling, and handling emergencies, she added.

Arvind Atignal, Chief Operating Officer, Clinigene, said that highest levels of safety would be maintained at the unit. "The investigator and sponsor will conduct clinical trials in compliance with global ethical and regulatory standards such as International Conference on Harmonisation, Good Clinical Practice, and Declaration of Helsinki regarding protection of human subjects," he added.

The Sagar Apollo Hospital Vice-Chairman, Premachandra Sagar, said the unit would help the pharmaceutical industry and society. It would also enable critical drugs to enter the market at a faster pace, he added.

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