Section 1 of 6
Terms and abbreviations
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| Abbreviation | Term |
|---|---|
| AAD | American Academy of Dermatology |
| ABCG2 | ATP-binding cassette subfamily G member 2 |
| AE | Adverse event |
| AESI | Adverse event of special interest |
| AHFS | American Hospital Formulary Service |
| ALAS2 | 5-aminolevulinate synthase 2 |
| ALP | Alkaline phosphatase |
| ALT | Alanine aminotransferase |
| AST | Aspartate aminotransferase |
| ATC | Anatomical Therapeutic Chemical classification |
| AUC | Area under the plasma concentration versus time curve |
| BCRP | Breast cancer resistance protein |
| BID | Twice daily |
| BMD | Bone mineral density |
| BMT | Bone marrow transplantation |
| CBC | Complete blood count |
| CDLQI | Children's Dermatology Life Quality Index |
| CI | Confidence interval |
| Cmax | Maximum observed plasma concentration |
| CNPV | Commissioner's National Priority Voucher |
| CRL | Complete response letter |
| CYP | Cytochrome P450 |
| DALY | Disability-adjusted life year |
| DBE | Double-blind extension |
| DBT | Double-blind treatment |
| DDI | Drug-drug interaction |
| DLQI | Dermatology Life Quality Index |
| ECG | Electrocardiogram |
| ED | Emergency department |
| eGFR | Estimated glomerular filtration rate |
| EMA | European Medicines Agency |
| EOT | End of treatment |
| EPIQ | Erythropoietic Protoporphyria Impact Questionnaire |
| EPP | Erythropoietic protoporphyria |
| EPP-QoL | Erythropoietic protoporphyria quality of life questionnaire |
| ePPIX | Erythrocyte protoporphyrin IX |
| EQ-5D | EuroQol 5 Dimensions |
| ERG | Evidence review group |
| FDA | U.S. Food and Drug Administration |
| FECH | Ferrochelatase |
| GGT | Gamma-glutamyl transferase |
| HADS | Hospital Anxiety and Depression Scale |
| HCC | Hepatocellular carcinoma |
| HCU | Healthcare utilization |
| HRQoL | Health-related quality of life |
| HRU | Healthcare resource utilization |
| HST | Highly specialised technologies |
| HTA | Health technology assessment |
| ICER | Incremental cost-effectiveness ratio |
| IHSI | International Horizon Scanning Initiative |
| IMP | Investigational medicinal product |
| IP | Inpatient |
| IQR | Interquartile range |
| IRB | Institutional review board |
| ITT | Intent-to-treat |
| LFT | Liver function test |
| LS | Least squares |
| LSMD | Least-squares mean difference |
| MAA | Marketing Authorisation Application |
| MAD | Multiple ascending dose |
| MC1R | Melanocortin 1 receptor |
| MCV | Mean corpuscular volume |
| MD | Melanin density |
| MedDRA | Medical Dictionary for Regulatory Activities |
| MMRM | Mixed-effect model for repeated measures |
| NDA | New Drug Application |
| NICE | National Institute for Health and Care Excellence |
| NoMA | Norwegian Medicines Agency |
| OAT | Organic anion transporter |
| OATP | Organic anion transporting polypeptide |
| OP | Outpatient |
| PBPF | Phototoxic burn protection factor |
| PBPK | Physiologically based pharmacokinetic |
| PBTT | Phototoxic burn tolerance time |
| PD | Pharmacodynamics |
| PDC | Proportion of days covered |
| PDUFA | Prescription Drug User Fee Act |
| PedsQL | Pediatric Quality of Life Inventory |
| PGIC | Patient Global Impression of Change |
| PGIS | Patient Global Impression of Severity |
| P-gp | P-glycoprotein |
| PK | Pharmacokinetics |
| PP | Per-protocol |
| PPIX | Protoporphyrin IX |
| PPPY | Per patient per year |
| PRO | Patient-reported outcome |
| PROMIS | Patient-Reported Outcomes Measurement Information System |
| QALY | Quality-adjusted life year |
| QD | Once daily |
| QoL | Quality of life |
| RR | Relative rate |
| SAD | Single ascending dose |
| SAE | Serious adverse event |
| SAP | Statistical analysis plan |
| SD | Standard deviation |
| SE | Standard error |
| SF-36 | 36-Item Short Form Health Survey |
| TEAE | Treatment-emergent adverse event |
| TPE | Therapeutic plasma exchange |
| TTP | Time to prodrome |
| UGT | Uridine diphosphate glucuronosyltransferase |
| ULN | Upper limit of normal |
| UVA | Ultraviolet A |
| UVB | Ultraviolet B |
| VAT | Value added tax |
| WAC | Wholesale acquisition cost |
| XLP | X-linked protoporphyria |
| ZnPP | Zinc protoporphyrin |