| Autor: |
Coutant, Michael, Zhihong Ge, McElvain, James S., Miller, Scott A., O'Connor, Dennis, Swanek, Frank, Szulc, Michael, Trone, Mark D., Wong-Moon, Kirby, Yazdanian, Mehran, Yehl, Peter, Zhang, Shuhong |
| Předmět: |
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| Zdroj: |
Pharmaceutical Technology Europe; Nov2012, Vol. 24 Issue 11, p26-32, 7p |
| Abstrakt: |
The article presents information on recommendations by the pharmaceutical industry experts for setting drug substance (DS) and drug product (DP) specifications in early development for conventional solid oral dosage forms intended for the U.S. regulatory submissions and for producing quality products with high patient safety and low production costs. Tables related to proposed DS, powder in tablet, powder in capsule and oral dosage specifications are also given. |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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