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Results: 1 to 20 of 132

1.

Predicting drug-drug interactions: an FDA perspective.

Zhang L, Zhang YD, Zhao P, Huang SM.

AAPS J. 2009 Jun;11(2):300-6. doi: 10.1208/s12248-009-9106-3. Epub 2009 May 6. Review.

PMID:
19418230
[PubMed - indexed for MEDLINE]
Free PMC Article
2.

Drug interactions evaluation: an integrated part of risk assessment of therapeutics.

Zhang L, Reynolds KS, Zhao P, Huang SM.

Toxicol Appl Pharmacol. 2010 Mar 1;243(2):134-45. doi: 10.1016/j.taap.2009.12.016. Epub 2010 Jan 4. Review.

PMID:
20045016
[PubMed - indexed for MEDLINE]
3.

A regulatory viewpoint on transporter-based drug interactions.

Zhang L, Zhang YD, Strong JM, Reynolds KS, Huang SM.

Xenobiotica. 2008 Jul;38(7-8):709-24. doi: 10.1080/00498250802017715 . Review.

PMID:
18668428
[PubMed - indexed for MEDLINE]
4.

Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues.

Huang SM, Lesko LJ, Williams RL.

J Clin Pharmacol. 1999 Oct;39(10):1006-14.

PMID:
10516934
[PubMed - indexed for MEDLINE]
5.

Preclinical pharmacokinetics: an approach towards safer and efficacious drugs.

Singh SS.

Curr Drug Metab. 2006 Feb;7(2):165-82. Review.

PMID:
16472106
[PubMed - indexed for MEDLINE]
6.

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ.

J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. Review.

PMID:
18378963
[PubMed - indexed for MEDLINE]
7.

Emerging role of drug interaction studies in drug development: the good, the bad, and the unknown.

Alfaro CL.

Psychopharmacol Bull. 2001 Autumn;35(4):80-93. Review.

PMID:
12397858
[PubMed - indexed for MEDLINE]
8.

Recent progresses in the experimental methods and evaluation strategies of transporter functions for the prediction of the pharmacokinetics in humans.

Kitamura S, Maeda K, Sugiyama Y.

Naunyn Schmiedebergs Arch Pharmacol. 2008 Jun;377(4-6):617-28. doi: 10.1007/s00210-008-0312-9. Epub 2008 Jun 7. Review.

PMID:
18536908
[PubMed - indexed for MEDLINE]
9.

Therapeutic protein-drug interactions and implications for drug development.

Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, Lesko LJ.

Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3.

PMID:
20200513
[PubMed - indexed for MEDLINE]
10.

Induction of drug metabolizing enzymes: a survey of in vitro methodologies and interpretations used in the pharmaceutical industry--do they comply with FDA recommendations?

Hewitt NJ, de Kanter R, LeCluyse E.

Chem Biol Interact. 2007 May 20;168(1):51-65. Epub 2006 Dec 28. Review.

PMID:
17239835
[PubMed - indexed for MEDLINE]
11.

Introduction to in vitro estimation of metabolic stability and drug interactions of new chemical entities in drug discovery and development.

Baranczewski P, StaƄczak A, Sundberg K, Svensson R, Wallin A, Jansson J, Garberg P, Postlind H.

Pharmacol Rep. 2006 Jul-Aug;58(4):453-72. Review.

PMID:
16963792
[PubMed - indexed for MEDLINE]
Free Article
12.

In vitro - in vivo correlation: from theory to applications.

Emami J.

J Pharm Pharm Sci. 2006;9(2):169-89.

PMID:
16959187
[PubMed - indexed for MEDLINE]
Free Article
13.

Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs.

Zolnik BS, Sadrieh N.

Adv Drug Deliv Rev. 2009 Jun 21;61(6):422-7. doi: 10.1016/j.addr.2009.03.006. Epub 2009 Apr 20. Review.

PMID:
19389437
[PubMed - indexed for MEDLINE]
14.

FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: impact on labeling.

Davit B, Reynolds K, Yuan R, Ajayi F, Conner D, Fadiran E, Gillespie B, Sahajwalla C, Huang SM, Lesko LJ.

J Clin Pharmacol. 1999 Sep;39(9):899-910.

PMID:
10471980
[PubMed - indexed for MEDLINE]
15.

Quantitative drug interactions prediction system (Q-DIPS): a computer-based prediction and management support system for drug metabolism interactions.

Bonnabry P, Sievering J, Leemann T, Dayer P.

Eur J Clin Pharmacol. 1999 Jul;55(5):341-7.

PMID:
10456482
[PubMed - indexed for MEDLINE]
16.

The use of in vitro methods to predict in vivo pharmacokinetics and drug interactions.

Bachmann KA, Ghosh R.

Curr Drug Metab. 2001 Sep;2(3):299-314. Review.

PMID:
11513332
[PubMed - indexed for MEDLINE]
17.

Prediction of drug metabolism and interactions on the basis of in vitro investigations.

Pelkonen O, Turpeinen M, Uusitalo J, Rautio A, Raunio H.

Basic Clin Pharmacol Toxicol. 2005 Mar;96(3):167-75. Review.

PMID:
15733211
[PubMed - indexed for MEDLINE]
18.

Systematic screening for pharmacokinetic interactions during drug development.

Fuhr U, Weiss M, Kroemer HK, Neugebauer G, Rameis H, Weber W, Woodcock BG.

Int J Clin Pharmacol Ther. 1996 Apr;34(4):139-51. Review.

PMID:
8861732
[PubMed - indexed for MEDLINE]
19.

Predicting inhibitory drug-drug interactions and evaluating drug interaction reports using inhibition constants.

Bachmann KA, Lewis JD.

Ann Pharmacother. 2005 Jun;39(6):1064-72. Epub 2005 May 10. Review.

PMID:
15886285
[PubMed - indexed for MEDLINE]
20.

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.

Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM.

Clin Pharmacol Ther. 2011 Feb;89(2):259-67. doi: 10.1038/clpt.2010.298. Epub 2010 Dec 29.

PMID:
21191381
[PubMed - indexed for MEDLINE]

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