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Veterinary Drug Residue Methods – Implications of the latest issue of Draft Volume 8 (Final Adoption by CVMP 14 February 2001)
As discussed in earlier editions of the Biographer, the requirements for regulatory methods within the EU continue to evolve. The latest draft edition of ‘Volume 8’ (available on the EMEA website: www.eudra.org) outlines the most specific “recommendations” to date. Although the guidelines are specifically for enforcement methods, it is widely accepted that these criteria also apply to analytical methods submitted as part of the MRL application process. Some of the new specific requirements that will impact on method validation design are as follows:
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