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Abbreviations
ОглавлениеAbbreviation | 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 |