| Autor: |
Steinberg M; Hercules Incorporated, Wilmington, Delaware 19894, USA., Borzelleca JF, Enters EK, Kinoshita FK, Loper A, Mitchell DB, Tamulinas CB, Weiner ML |
| Jazyk: |
angličtina |
| Zdroj: |
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 1996 Oct; Vol. 24 (2 Pt 1), pp. 149-54. |
| DOI: |
10.1006/rtph.1996.0120 |
| Abstrakt: |
This article presents a set of proposed guidelines for the safety assessment of new pharmaceutical excipients. These guidelines were developed by the Safety Committee of the International Pharmaceutical Excipients Council and represent a new, scientifically based approach to establishing conditions for the safe use of proposed pharmaceutical excipients utilizing various routes of human exposure. They are based upon the best currently available toxicological science and have taken the deliberations of the International Conference on Harmonization into consideration. These guidelines were developed because there are no regulatory agency guidelines currently available which specifically address the toxicological testing of a material intended for use as an excipient in pharmaceutical preparations. Only materials which have been previously permitted for use in a pharmaceutical preparation or which have been permitted for use in foods may be considered safe under current practices. If implemented, these guidelines should expedite the review of a proposed new excipient by regulatory agencies. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
|
Full Text from ScienceDirect