Table 1.4 Abbreviations used in biologic medicine literature.
| Abbreviation | Full name |
|---|---|
| ADCs | Antibody–Drug Conjugates |
| ADR | Adverse Drug Reaction |
| ADE | Adverse Drug Event |
| AE | Adverse Event |
| ANDA | Abbreviated New Drug Application |
| ARTG | Australian Register of Therapeutic Goods |
| ATMP | Advanced Therapy Medicinal Products |
| BDMARDs | Biologic Disease‐Modifying Anti‐Rheumatic Drugs |
| BIA | Budget Impact Analysis |
| BLA | Biologics License Application |
| BPCI Act | Biologics Price Competition and Innovation Act |
| CAPs | Centrally Authorised Products (EU) |
| CAR‐T | Chimeric Antigen Receptor Therapy |
| CDMO | Contract Development and Manufacturing Organisation |
| CEOR | ClinicoEconomics and Outcomes Research |
| CHMP | Committee for Medicinal Products for Human Use (EMA) |
| CIOMS | Council for International Organizations of Medical Sciences |
| CE | Comparability Exercise |
| CMA | Critical Material Attribute |
| CPP | Critical Process Parameter |
| CQA | Critical Quality Attribute |
| CTD | Common Technical Document |
| DCP | Decentralised Procedure |
| DDD | Defined Daily Dose |
| DDR | Dose‐Dense Regimens |
| EC | European Commission |
| EMA (EMEA) | European Medicines Agency |
| EPARs | European Public Assessment Reports |
| EPO | Erythropoietin (epoetin) |
| EU | European Union |
| Eudra | European Drug Regulatory Authorities |
| FDA | Food and Drug Administration |
| FD&C | Food, Drug, and Cosmetic |
| FTC | Federal Trade Commission (in the United States) |
| GCP | Good Clinical Practice |
| GH | Growth Hormone |
| GMP | Good Manufacturing Practice |
| GVP | Good Pharmacovigilance Practice |
| HCPCS | Healthcare Common Procedure Coding System |
| HPLC | High‐Performance Liquid Chromatography |
| IBD | Inflammatory Bowel Disease |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| INN | International Non‐proprietary Name |
| IP | Intellectual Property |
| LDN | Limited Distribution Network |
| LMWH | Low Molecular Weight Heparins |
| MA | Marketing Authorisation |
| MAA | Marketing Authorisation Application |
| MCOs | Managed Care Organisations |
| MR | Mutual Recognition |
| NHS | National Health Service |
| NDA | New Drug Application |
| NMS | Non‐Medical Switching |
| NICE | National Institute for Clinical Excellence (UK) |
| mAb | Monoclonal Antibody |
| PBAC | Pharmaceutical Benefits Advisory Committee |
| PBS | Pharmaceutical Benefits Scheme |
| PFS | Pre‐Filled Syringe |
| PHS | Public Health Service |
| PMS | Post‐Marketing Surveillance |
| PPRS |
Pharmaceutical Price
|