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Guideline on Comparability after a change in the ...
www.ema.europa.eucommittee for human medicinal products (chmp) guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process non-clinical and clinical issues draft agreed by bmwp1 december 2006 adoption by chmp for release for consultation january 2007 end of consultation (deadline for comments) april 2007