Commercial Development Considerations for Biotechnology-Derived Therapeutics
| Autor: | B. J. Marafino, Michael K. Pugsley |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Protein therapeutics
Drug Industry United States Food and Drug Administration business.industry medicine.drug_class Pharmacology toxicology Antibodies Monoclonal Protein Engineering Toxicology Monoclonal antibody Recombinant Proteins United States Biotechnology Food and drug administration Cardiovascular Diseases Drug Design Humans Medicine Cardiology and Cardiovascular Medicine business Drug Approval Molecular Biology |
| Zdroj: | Cardiovascular Toxicology. 3:5-12 |
| ISSN: | 1530-7905 |
| DOI: | 10.1385/ct:3:1:5 |
| Popis: | Although it seems unlikely, it has only been 20 years since the US Food and Drug Administration (FDA) approved the first recombinant protein as a therapeutic modality. Unbelievably, an average of slightly more than two approvals per year of monoclonal antibodies (MAbs) and other human protein therapeutics has been achieved by this burgeoning industry 43 recombinant protein therapeutics in the two decades since 1982 (see Table 1), and the pace is increasing. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink