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Regulatory Considerations for AntibodyDrug Conjugates Sarah Pope Miksinski, Ph.D. (ONDQA) Marjorie Shapiro, Ph.D. (OBP) OPS, CDER AAPS (October 18, 2012)
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Company
Monoclonal Antibody /
/
IndustryTerm
cell bank /
manufacturing processes /
drug product /
/
MedicalCondition
tumor /
/
Organization
office of Compliance /
/
Person
Marjorie Shapiro /
/
Position
PAI lead inspector /
/
Technology
ADC /
Biotechnology /
/
SocialTag
Biotechnology
Monoclonal antibodies
Antibody
Effector
SHA
Immune system
Biology
Immunology
Regulatory Considerations for AntibodyDrug Conjugates Sarah Pope Miksinski, Ph.D. (ONDQA) Marjorie Shapiro, Ph.D. (OBP) OPS, CDER AAPS (October 18, 2012)