BioPharm authors have tackled this subject several times in the past. Here are a few related articles and columns. Order copies online at www.pharmaportal.com.
M.A. Schenerman and K. Phillips, "Comparability (Bioequivalence) Testing of Monoclonal Antibodies," April 1997, 20-26.
L. Little, "Current Trends: Impact of the Well-Characterized Regulatory Paradigm," August 1997, 8-12, 58.
J. Morgan and N. Chew, "Regulatory Affairs: Reinventing FDA, Part 3 - Postapproval Changes," April 1998, 16-18, 56.
M. Behizad and D. Gains, "Regulatory Aspects of Column Chromatography in Biopharmaceutical Manufacturing: US and EU …
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