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Abbreviations
ОглавлениеAbbreviation | Full name |
ABPI | Association of British Pharmaceutical Industry |
AfPA | Alliance for Patient Access |
BAP | Biosimilars Action Plan |
BLA | Biologics License Application |
BPC | Biologics Prescribers Collaborative |
BPCI Act | Biologics Price Competition and Innovation Act |
CAR‐T | Chimeric Antigen Receptor Therapy |
CHMP | Committee for Medicinal Products for Human Use (EMA) |
CIOMS | Council of International Organizations of Medical Sciences |
CQAs | Critical Quality Attributes |
CVMP | Committee for Medicinal Products for Veterinary Use |
Da | Dalton |
DNA | Deoxyribonucleic Acid |
EMA | European Medicines Agency |
EPAR | European Public Assessment Report |
EU | European Union |
FDA | Food and Drug Administration |
GABi/GaBI | Generics and Biosimilars Initiative |
LDN | Limited Distribution Network |
mAbs | monoclonal Antibodies |
NHS | National Health Service |
NICE | National Institute for Clinical Excellence |
NMS | Non‐Medical Switching |
NOBs | Non‐Original Biologics |
PBS | Pharmaceutical Benefits Scheme |
P&T | Pharmacy & Therapeutics (Committee) |
PTMs | Post‐Translational Modifications |
QbD | Quality by Design |
QUM | Quality Use of Medicine |
RMP | Risk Management Plan |
RPS | Reference Product Sponsor |
RWE | Real‐World Evidence |
SEBs | Subsequent‐Entry Biologics |
SMD | Small Molecule Drug |
UMC | Uppsala Monitoring Centre |
UNESCO | United Nations Educational, Scientific and Cultural Organization |
USA | United States of America |
USD | US Dollar |
WHO | World Health Organisation |