共 8 条
[1]
Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice
[J].
Grillo, Joseph A.
;
Zhao, Ping
;
Bullock, Julie
;
Booth, Brian P.
;
Lu, Min
;
Robie-Suh, Kathy
;
Berglund, Eva Gil
;
Pang, K. Sandy
;
Rahman, Atiqur
;
Zhang, Lei
;
Lesko, Lawrence J.
;
Huang, Shiew-Mei
.
BIOPHARMACEUTICS & DRUG DISPOSITION,
2012, 33 (02)
:99-110

Grillo, Joseph A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Zhao, Ping
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Bullock, Julie
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Booth, Brian P.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Lu, Min
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, DHP, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Robie-Suh, Kathy
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, DHP, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Berglund, Eva Gil
论文数: 0 引用数: 0
h-index: 0
机构:
Med Prod Agcy, Uppsala, Sweden US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Pang, K. Sandy
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Toronto, Leslie Dan Fac Pharm, Toronto, ON M5S 1A1, Canada US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Rahman, Atiqur
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Zhang, Lei
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Lesko, Lawrence J.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Huang, Shiew-Mei
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[2]
The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review
[J].
Huang, S-M
;
Rowland, M.
.
CLINICAL PHARMACOLOGY & THERAPEUTICS,
2012, 91 (03)
:542-549

Huang, S-M
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Rowland, M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[3]
Leong R, CLIN PHARM IN PRESS
[4]
Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science
[J].
Rowland, Malcolm
;
Peck, Carl
;
Tucker, Geoffrey
.
ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 51, 2011,
2011, 51
:45-73

Rowland, Malcolm
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Manchester, Ctr Pharmacokinet Res, Sch Pharm & Pharmaceut Sci, Manchester M13 9PT, Lancs, England Univ Manchester, Ctr Pharmacokinet Res, Sch Pharm & Pharmaceut Sci, Manchester M13 9PT, Lancs, England

Peck, Carl
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Calif San Francisco, Sch Med, Ctr Drug Dev Sci, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA
Univ Calif San Francisco, Sch Pharm, Ctr Drug Dev Sci, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA Univ Manchester, Ctr Pharmacokinet Res, Sch Pharm & Pharmaceut Sci, Manchester M13 9PT, Lancs, England

Tucker, Geoffrey
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Sheffield, Royal Hallamshire Hosp, Sheffield S10 2JF, S Yorkshire, England
Simcyp Ltd, Sheffield S2 4SU, S Yorkshire, England Univ Manchester, Ctr Pharmacokinet Res, Sch Pharm & Pharmaceut Sci, Manchester M13 9PT, Lancs, England
[5]
Viera MLT, CLIN PHARM IN PRESS
[6]
Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development
[J].
Zhang, Xinyuan
;
Lionberger, Robert A.
;
Davit, Barbara M.
;
Yu, Lawrence X.
.
AAPS JOURNAL,
2011, 13 (01)
:59-71

Zhang, Xinyuan
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, OGD, Rockville, MD 20857 USA US FDA, OGD, Rockville, MD 20857 USA

Lionberger, Robert A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, OGD, Rockville, MD 20857 USA US FDA, OGD, Rockville, MD 20857 USA

Davit, Barbara M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, OGD, Rockville, MD 20857 USA US FDA, OGD, Rockville, MD 20857 USA

Yu, Lawrence X.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, OGD, Rockville, MD 20857 USA US FDA, OGD, Rockville, MD 20857 USA
[7]
Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review
[J].
Zhao, P.
;
Zhang, L.
;
Grillo, J. A.
;
Liu, Q.
;
Bullock, J. M.
;
Moon, Y. J.
;
Song, P.
;
Brar, S. S.
;
Madabushi, R.
;
Wu, T. C.
;
Booth, B. P.
;
Rahman, N. A.
;
Reynolds, K. S.
;
Berglund, E. Gil
;
Lesko, L. J.
;
Huang, S-M
.
CLINICAL PHARMACOLOGY & THERAPEUTICS,
2011, 89 (02)
:259-267

Zhao, P.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Zhang, L.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Grillo, J. A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Liu, Q.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Bullock, J. M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Moon, Y. J.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Song, P.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Brar, S. S.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Madabushi, R.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Wu, T. C.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Booth, B. P.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Rahman, N. A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Reynolds, K. S.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Berglund, E. Gil
论文数: 0 引用数: 0
h-index: 0
机构:
Med Prod Agcy, Efficacy & Safety 2, Uppsala, Sweden US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Lesko, L. J.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

Huang, S-M
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[8]
Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation
[J].
Zhao, Ping
;
Vieira, Manuela de L. T.
;
Grillo, Joseph A.
;
Song, Pengfei
;
Wu, Ta-Chen
;
Zheng, Jenny H.
;
Arya, Vikram
;
Berglund, Eva Gil
;
Atkinson, Arthur J., Jr.
;
Sugiyama, Yuichi
;
Pang, K. Sandy
;
Reynolds, Kellie S.
;
Abernethy, Darrell R.
;
Zhang, Lei
;
Lesko, Lawrence J.
;
Huang, Shiew-Mei
.
JOURNAL OF CLINICAL PHARMACOLOGY,
2012, 52
:91S-108S

Zhao, Ping
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Vieira, Manuela de L. T.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA
Univ Florida, Dept Pharmaceut, Gainesville, FL USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Grillo, Joseph A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Song, Pengfei
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Wu, Ta-Chen
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Zheng, Jenny H.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Arya, Vikram
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Berglund, Eva Gil
论文数: 0 引用数: 0
h-index: 0
机构:
Med Prod Agcy, Uppsala, Sweden US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Atkinson, Arthur J., Jr.
论文数: 0 引用数: 0
h-index: 0
机构:
Northwestern Univ, Chicago, IL 60611 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

论文数: 引用数:
h-index:
机构:

Pang, K. Sandy
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Toronto, Leslie Dan Fac Pharm, Toronto, ON M5S 1A1, Canada US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Reynolds, Kellie S.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Abernethy, Darrell R.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Zhang, Lei
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Lesko, Lawrence J.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

Huang, Shiew-Mei
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA
