Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes

Journal Title: The AAPS Journal - Year 2013, Vol 15, Issue 1

Abstract

The online version of this article (doi:10.1208/s12248-012-9414-x) contains supplementary material, which is available to authorized users.

Authors and Affiliations

Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel, Chris Macaraeg, Kinnari Pandya, Judy Shih, Mark Ma, Jean W. Lee, Binodh DeSilva

Keywords

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  • EP ID EP681748
  • DOI  10.1208/s12248-012-9414-x
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How To Cite

Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel, Chris Macaraeg, Kinnari Pandya, Judy Shih, Mark Ma, Jean W. Lee, Binodh DeSilva (2013). Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes. The AAPS Journal, 15(1), -. https://europub.co.uk/articles/-A-681748