What's the Regulatory Value of a Target Product Profile?
| Autor: | Wenny Du, Adria Tyndall, Christopher D. Breder |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
business.industry United States Food and Drug Administration Time to market Product profile Bioengineering humanities United States 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Value (economics) New product development Humans 030212 general & internal medicine Business Product (category theory) Dialog box Drug Approval Industrial organization Biotechnology |
| Zdroj: | Trends in biotechnology. 35(7) |
| ISSN: | 1879-3096 |
| Popis: | Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. |
| Databáze: | OpenAIRE |
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