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Report on the AAPS Immunogenicity Guidance Forum.
Myler, Heather; Gorovits, Boris; Phillips, Kelli; Devanarayan, Viswanath; Clements-Egan, Adrienne; Gunn, George R; Kirshner, Susan; DeSilva, Binodh; Shah, Vinod P.
Affiliation
  • Myler H; Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppdi.com.
  • Gorovits B; Biomedicine Design, Pfizer, Andover, Massachusetts, 01810, USA.
  • Phillips K; Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA.
  • Devanarayan V; Statistics and Data Sciences, Charles River Laboratories, Horsham, Pennsylvania, 19044, USA.
  • Clements-Egan A; Biologics Development Sciences, Janssen, Spring House, Pennsylvania, 19477, USA.
  • Gunn GR; Immunogenicity and Clinical Immunology, GSK, Collegeville, Pennsylvania, 19426, USA.
  • Kirshner S; Product Quality and Immunogenicity, FDA, Silver Spring, Maryland, 20903, USA.
  • DeSilva B; Analytical Strategy & Operations, Bristol-Myers Squibb, Princeton, New Jersey, 08540, USA.
  • Shah VP; Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.
AAPS J ; 21(4): 55, 2019 04 16.
Article in En | MEDLINE | ID: mdl-30993501
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products / Proteins / Guidelines as Topic / Antibodies Type of study: Guideline Limits: Animals Country/Region as subject: America do norte Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2019 Document type: Article Affiliation country: United States Country of publication: United States
Fulltext
Add to My VHL
Print
XML
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products / Proteins / Guidelines as Topic / Antibodies Type of study: Guideline Limits: Animals Country/Region as subject: America do norte Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2019 Document type: Article Affiliation country: United States Country of publication: United States