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Abbreviations

Оглавление
Abbreviation Full name
ADA Adenosine Deaminase Deficiency
ADC Antibody–Drug Conjugate
ANDA Abbreviated New Drug Application
BLA Biologics License Application
BPCIA Biologics Price Competition and Innovation Act
CBER Center for Biologics Evaluation and Research
CDE Center for Drug Evaluation
CDER Center for Drug Evaluation and Research
CFDA China Food and Drug Administration
COPD Chronic Obstructive Pulmonary Disease
CTA Clinical Trials Application
DO Drug Organization (Japan)
DRG Diagnosis‐Related Groups
EGRF Endothelial Growth Factor Receptor
EMA European Medicines Agency
EU European Union
FDA Food and Drug Administration
GCP Good Clinical Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
HER‐2 Human Epidermal Growth Factor Receptor‐2
IDL Import Drug License (China)
IL‐5 Interleukin‐5
IMS Intercontinental Medical Statistics
IV Intravenous
JAAME Japanese Association for the Advancement of Medical Equipment
KIKO Another Name for OPSR (Japan)
LLP Lipoprotein Lipase Deficiency
mABs Monoclonal Antibodies
MHLW Ministry of Health, Labour and Welfare (Japan)
MIDAS Market Information on Global Sales Activities (from IQVIA)
NASDAQ (Index) National Association of Securities Dealers Automated Quotations (Index)
NOBs Non‐Original Biologics
OPSR Organization for Pharmaceutical Safety and Research
PCSK‐9 Proprotein Convertase Subtilisin/Kexin type 9
PMDA Pharmaceuticals and Medical Devices Agency (Japan)
PMDEC The Pharmaceuticals and Medical Devices Evaluation Center
R&D Research and Development
SC Subcutaneous
SCID Severe‐Combined Immuno‐Deficiency
TGA Therapeutic Goods Administration
TNF Tumor Necrosis Factor
WHO World Health Organization

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