Section 1 of 6
Terms and abbreviations
1 evidence topic · 0 sources
| Abbreviation | Term |
|---|---|
| 3PL | Third-party logistics |
| ADA | Anti-drug antibody |
| AMD | Age-related macular degeneration |
| ATE | Arterial thromboembolic event |
| AUC | Area under the concentration-time curve |
| BCVA | Best corrected visual acuity |
| BLA | Biologics license application |
| BPCIA | Biologics Price Competition and Innovation Act |
| BRVO | Branch retinal vein occlusion |
| CATT | Comparison of Age-related Macular Degeneration Treatments Trials |
| CFR | Code of Federal Regulations |
| CFT | Central foveal thickness |
| CI | Confidence interval |
| Cmax | Maximum plasma concentration |
| CMC | Chemistry, manufacturing, and controls |
| CNV | Choroidal neovascularization |
| CRL | Complete response letter |
| DME | Diabetic macular edema |
| EC | European Commission |
| ETDRS | Early Treatment Diabetic Retinopathy Study |
| EU | European Union |
| FDA | Food and Drug Administration |
| FES-I | Falls Efficacy Scale-International |
| GA | Geographic atrophy |
| HCPCS | Healthcare Common Procedure Coding System |
| ICGA | Indocyanine green angiography |
| ITT | Intention-to-treat |
| MHRA | Medicines and Healthcare products Regulatory Agency |
| nAMD | Neovascular age-related macular degeneration |
| NCT | National Clinical Trial (ClinicalTrials.gov identifier prefix) |
| NI | Non-inferiority |
| OCT | Optical coherence tomography |
| OCTA | Optical coherence tomography angiography |
| ONS-5010 | Development code name for bevacizumab-vikg used prior to FDA approval |
| PCV | Polypoidal choroidal vasculopathy |
| PDT | Photodynamic therapy |
| PDUFA | Prescription Drug User Fee Act |
| PED | Pigment epithelial detachment |
| PFS | Pre-filled syringe |
| PP | Per-protocol |
| PRN | As needed (pro re nata) |
| Q12W | Every 12 weeks |
| Q16W | Every 16 weeks |
| RPE | Retinal pigment epithelium |
| RVO | Retinal vein occlusion |
| SD | Standard deviation |
| SPA | Special Protocol Assessment |
| UK | United Kingdom |
| VEGF | Vascular endothelial growth factor |
| WAC | Wholesale acquisition cost |