Bioequivalence and Bioavailability Forum

All scientific guidelines relating to demonstrating efficacy of veterinary medicines (including bioequivalence) can be found at the following link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000381.jsp&mid=WC0b01ac058002ddc2

As you will see there is an adopted guideline that has been in place since November 2011, but the draft VICH GL52 is out on consultation until the end of this month so any comments would need to be sent quickly.

VICH GL52 on Bioequivalence: blood level bioequivalence study Draft Guideline EMA/CVMP/VICH/751935/2013 Release for consulation Dec 2013 End of consultation 31 May 2014

Simon