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Anti-drug Antibody Validation Testing and Reporting Harmonization

Myler Heather,Pedras-Vasconcelos João,Phillips Kelli,Hottenstein Charles Scott,Chamberlain Paul,Devanaryan Viswanath,Gleason Carol,Goodman Joanne,Manning Marta Starcevic,Purushothama Shobha,Richards Susan,Shen Honglue,Zoghbi Jad,Amaravadi Lakshmi,Barger Troy, Bowen Steven,Bowsher Ronald R.,Clements-Egan Adrienne,Geng Dong,Goletz Theresa J.,Gunn George R., Hallett William,Hodsdon Michael E.,Janelsins Brian M.,Jawa Vibha,Kamondi Szilard,Kirshner Susan,Kramer Daniel,Liang Meina, Lindley Kathryn,Liu Susana, Liu ZhenZhen,McNally Jim,Mikulskis Alvydas,Nelson Robert, Ahbari Mohsen Rajabi,Qu Qiang,Ruppel Jane,Snoeck Veerle,Song An,Yan Haoheng,Ware Mark

The AAPS Journal（2021）

Cited 33|Views55
Key words
Anti-drug antibodies (ADA),FDA,Immunogenicity,Neutralizing antibodies (NAb),Regulatory guidance,Validation
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