Zdrowie i gospodarka · 21/07/2009

FDA Publishes Draft Guidance on Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products

The US Food and Drug Administration (FDA) has released a draft guidance document, VICH GL45, which provides industry with reduced design options for stability testing of new veterinary drugs, building on the principles outlined in the 2007 VICH GL3(R) guidance.