Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

מאת Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.
יצא לאור 2008

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

מאת Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.
יצא לאור 2008

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

מאת Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert
הוצא לאור ב AAPS J (2015)

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

מאת Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert
הוצא לאור ב AAPS J (2015)

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

מאת Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann, Donald J., Yu, Lawrence X.
יצא לאור 2012