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Guidance for industry : assay development for immunogenicity testing of therapeutic proteins.
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Immunogenetics--United States.
- Immunogenetics.
- Biological assay.
- Proteins--Therapeutic use--Testing.
- Proteins.
- United States.
- Physical Description:
- 1 online resource (20 pages) : illustrations
- Other Title:
- Assay development for immunogenicity testing of therapeutic proteins
- Place of Publication:
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]
- Notes:
- "Draft guidance."
- "CMC."
- "December 2009."
- Includes bibliographical references (pages 19-20).
- OCLC:
- 558588044
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