Abstract
The lack of a pathway for regulatory approval of novel excipients outside a new drug development. The authors, respresenting the International Pharmaceutical Excipients Council, propose a new evalutio procedure, including tiered toxicology testing that may change the way pharmaceutical and biopharmaceutical manufacturers look at drug-product development.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 72-82 |
| Number of pages | 11 |
| Journal | Pharmaceutical Technology |
| Volume | 33 |
| Issue number | 11 |
| State | Published - 2009 |
| Externally published | Yes |
All Science Journal Classification (ASJC) codes
- Biophysics
- Pharmaceutical Science