Guidance for Industry - Assay Development
Assay Development for Immunogenicity Testing of Therapeutic Proteins, Draft Guidance http://www.ipm-biotech.de/fileadmin/user_upload/pdf/guidelines/FDA-GUIDANCE-Assay-Development-Immunogenicity-Testing.pdf
Assay Development for Immunogenicity Testing of Therapeutic Proteins, Draft Guidance
http://www.ipm-biotech.de/fileadmin/user_upload/pdf/guidelines/FDA-GUIDANCE-Assay-Development-Immunogenicity-Testing.pdf
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Contains Nonbinding Recommendations<br />
Draft — Not <strong>for</strong> Implementation<br />
12. Shankar G, Devanarayan V, Amaravadi L, Barret YC, Bowsher R, Finco-Kent D, et al. 2008<br />
Epub ahead of print, Recommendations <strong>for</strong> the Validation of Immunoassays used <strong>for</strong><br />
Detection of Host Antibodies Against Biotechnology Products, J Pharm Biomed Anal.<br />
C:\8495dft.doc<br />
11/4/09<br />
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