Impact of recent Indian regulatory change on Bioequivalence studies
Saturday, 3 January 2015
Requirement of approval from CDSCO for conducting Bioavailability/Bioequivalence studies
Clinical / Bio-analytical unit conducting Bioavailability/Bioequivalecne studies should be approved from CDSCO (C
ENTRAL DRUGS STANDARD CONTROL ORGANIZATION) as per office memorandum from DCGI (effective from 09 Jan. 2014).
http://www.cdsco.nic.in/writereaddata/Office%20Memorandum.pdf
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