Clinical Studies of Drug-Drug Interactions: Design and Interpretation

被引：26

作者：

Greenblatt, David J. ^{[1
,2
]}

von Moltke, Lisa L. ^{[3
]}

机构：

[1] Tufts Univ, Sch Med, Dept Pharmacol & Expt Therapeut, Boston, MA 02111 USA

[2] Tufts Med Ctr, Boston, MA USA

[3] Millenium Pharmaceut Inst, Cambridge, MA USA

来源：

ENZYME- AND TRANSPORTER-BASED DRUG-DRUG INTERACTIONS: PROGRESS AND FUTURE CHALLENGES | 2010年

关键词：

IN-VITRO DATA; CYTOCHROME-P450 3A ACTIVITY; QUANTITATIVE PREDICTION; INHIBITION CONSTANTS; FLUVOXAMINE; TERFENADINE; METABOLISM; PHARMACOKINETICS; COCKTAIL; KETOCONAZOLE;

D O I：

10.1007/978-1-4419-0840-7_24

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The potential importance of drug-drug interaction (DDIs) is increasing as polypharmacy becomes more and more prevalent. In vitro data cannot directly predict clinical DDIs, but may provide a rationale for initiation of human studies to confirm or exclude possible interactions. Clinical DDI studies are designed to determine whether there is a real drug interaction not due to chance, how big the interaction is, and whether the DDI is of clinical importance. Statistical significance is not equivalent to clinical significance, and supplemental pharmacodynamic or clinical outcome information is needed to address the importance of a pharmacokinetic DDI.

引用

页码：625 / 649

页数：25

共 108 条

[1] Desipramine pharmacokinetics when coadministered with paroxetine or sertraline in extensive metabolizers [J].

Alderman, J ;

Preskorn, SH ;

Greenblatt, DJ ;

Harrison, W ;

Penenberg, D ;

Allison, J ;

Chung, M .

JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, 1997, 17 (04) :284-291

[2] Inhibition constants, inhibitor concentrations and the prediction of inhibitory drug drug interactions: Pitfalls, progress and promise [J].

Bachmann, KA .

CURRENT DRUG METABOLISM, 2006, 7 (01) :1-14

[3] Predicting inhibitory drug-drug interactions and evaluating drug interaction reports using inhibition constants [J].

Bachmann, KA ;

Lewis, JD .

ANNALS OF PHARMACOTHERAPY, 2005, 39 (06) :1064-1072

[4] Influence of the CYP1A2 inhibitor fluvoxamine on tacrine pharmacokinetics in humans [J].

Becquemont, L ;

Ragueneau, I ;

LeBot, MA ;

Riche, C ;

FunckBrentano, C ;

Jaillon, P .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 1997, 61 (06) :619-627

[5] Drug interactions in primary care: Impact of a new algorithm on risk determination [J].

Bergk, V ;

Gasse, C ;

Rothenbacher, D ;

Loew, M ;

Brenner, H ;

Haefeli, WE .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2004, 76 (01) :85-96

[6]

BIAGGIONI I, 1991, J PHARMACOL EXP THER, V258, P588

[7] Pharmacokinetic and pharmacodynamic assessment of a five-probe metabolic cocktail for CYPs 1A2, 3A4, 2C9, 2D6 and 2E1 [J].

Blakey, GE ;

Lockton, JA ;

Perrett, J ;

Norwood, P ;

Russell, M ;

Aherne, Z ;

Plume, J .

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2004, 57 (02) :162-169

[8] Prediction of in vivo drug-drug interactions from in vitro data -: Factors affecting prototypic drug-drug interactions involving CYP2C9, CYP2D6 and CYP3A4 [J].

Brown, Hayley S. ;

Galetin, Aleksandra ;

Hallifax, David ;

Houston, J. Brian .

CLINICAL PHARMACOKINETICS, 2006, 45 (10) :1035-1050

[9] Prediction of in vivo drug-drug interactions from in vitro data:: impact of incorporating parallel pathways of drug elimination and inhibitor absorption rate constant [J].

Brown, HS ;

Ito, K ;

Galetin, A ;

Houston, JB .

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2005, 60 (05) :508-518

[10] Combined phenotypic assessment of cytochrome P450 1A2, 2C9, 2C19, 2D6, and 3A, N-acetyltransferase-2, and xanthine oxidase activities with the "Cooperstown 5+1 cocktail" [J].

Chainuvati, S ;

Nafziger, AN ;

Leeder, JS ;

Gaedigk, A ;

Kearns, GL ;

Sellers, E ;

Zhang, YH ;

Kashuba, ADM ;

Rowland, E ;

Bertino, JS .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2003, 74 (05) :437-447

← 1 2 3 4 5 6 7 8 9 10 →