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Of Biotechnological Products

Found 2 free book(s)

Guideline on Comparability after a change in the ...

www.ema.europa.eu

committee 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

  Product, Change, Process, Manufacturing, Clinical, Change in the manufacturing process non clinical and

ICH HARMONISED TRIPARTITE GUIDELINE

database.ich.org

Guidelines Q6A and Q6B, but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities. It is particularly

  Product

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