-
1
-
-
84900874123
-
Drug interactions for therapeutic proteins: A journey just beginning
-
Zhou H, Meibohm B, eds Hoboken, NJ: Wiley
-
Zhou H, Meibohm B,. Drug interactions for therapeutic proteins: a journey just beginning. In: Zhou H, Meibohm B, eds. Drug-Drug Interactions for Therapeutic Biologics. Hoboken, NJ: Wiley; 2013: 1-4.
-
(2013)
Drug-Drug Interactions for Therapeutic Biologics
, pp. 1-4
-
-
Zhou, H.1
Meibohm, B.2
-
2
-
-
84954370954
-
-
Center for Drug Evaluation and Research (CDER). February 2012. Accessed December 18, 2014
-
Guidance for Industry DISD, Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (draft), Center for Drug Evaluation and Research (CDER). February 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm292362.pdf. Accessed December 18, 2014.
-
Guidance for Industry DISD, Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (Draft)
-
-
-
3
-
-
84882779915
-
Critical review of preclinical approaches to investigate cytochrome p450-mediated therapeutic protein drug-drug interactions and recommendations for best practices: A white paper
-
Evers R, Dallas S, Dickmann LJ, et al., Critical review of preclinical approaches to investigate cytochrome p450-mediated therapeutic protein drug-drug interactions and recommendations for best practices: a white paper. Drug Metab Dispos. 2013; 41 (9): 1598-1609.
-
(2013)
Drug Metab Dispos.
, vol.41
, Issue.9
, pp. 1598-1609
-
-
Evers, R.1
Dallas, S.2
Dickmann, L.J.3
-
4
-
-
17644368573
-
Interleukin-6: From basic science to medicine-40 years in immunology
-
Kishimoto T., Interleukin-6: from basic science to medicine-40 years in immunology. Annu Rev Immunol. 2005; 23: 1-21.
-
(2005)
Annu Rev Immunol.
, vol.23
, pp. 1-21
-
-
Kishimoto, T.1
-
5
-
-
0025274640
-
Cytokines and cytokine inhibitors or antagonists in rheumatoid arthritis
-
Arend WP, Dayer JM,. Cytokines and cytokine inhibitors or antagonists in rheumatoid arthritis. Arthritis Rheum. 1990; 33 (3): 305-315.
-
(1990)
Arthritis Rheum.
, vol.33
, Issue.3
, pp. 305-315
-
-
Arend, W.P.1
Dayer, J.M.2
-
6
-
-
0027443904
-
Cytokines down-regulate expression of major cytochrome P-450 enzymes in adult human hepatocytes in primary culture
-
Abdel-Razzak Z, Loyer P, Fautrel A, et al., Cytokines down-regulate expression of major cytochrome P-450 enzymes in adult human hepatocytes in primary culture. Mol Pharmacol. 1993; 44 (4): 707-715.
-
(1993)
Mol Pharmacol.
, vol.44
, Issue.4
, pp. 707-715
-
-
Abdel-Razzak, Z.1
Loyer, P.2
Fautrel, A.3
-
7
-
-
34548090571
-
Gene-specific effects of inflammatory cytokines on cytochrome P450 2C, 2B6 and 3A4 mRNA levels in human hepatocytes
-
Aitken AE, Morgan ET,. Gene-specific effects of inflammatory cytokines on cytochrome P450 2C, 2B6 and 3A4 mRNA levels in human hepatocytes. Drug Metab Dispos. 2007; 35 (9): 1687-1693.
-
(2007)
Drug Metab Dispos.
, vol.35
, Issue.9
, pp. 1687-1693
-
-
Aitken, A.E.1
Morgan, E.T.2
-
8
-
-
77949873408
-
Disease-Drug Interaction Studies of Tocilizumab with Cytochrome P450 Substrates in Vitro and in Vivo
-
Zhang X, Schmitt C, Grange S, et al., Disease-Drug Interaction Studies of Tocilizumab with Cytochrome P450 Substrates In Vitro And In Vivo. Clin Pharmacol Ther. 2009; 85: S37-S64.
-
(2009)
Clin Pharmacol Ther.
, vol.85
, pp. S37-S64
-
-
Zhang, X.1
Schmitt, C.2
Grange, S.3
-
9
-
-
79955465387
-
Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis
-
Schmitt C, Kuhn B, Zhang X, Kivitz AJ, Grange S., Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011; 89 (5): 735-740.
-
(2011)
Clin Pharmacol Ther.
, vol.89
, Issue.5
, pp. 735-740
-
-
Schmitt, C.1
Kuhn, B.2
Zhang, X.3
Kivitz, A.J.4
Grange, S.5
-
10
-
-
84954401140
-
-
South San Francisco, CA, Inc
-
Actemra [package insert]. South San Francisco, CA, Inc; 2014.
-
(2014)
Actemra [Package Insert]
-
-
-
11
-
-
33846607427
-
Appropriate phenotyping procedures for drug metabolizing enzymes and transporters in humans and their simultaneous use in the "cocktail" approach
-
Fuhr U, Jetter A, Kirchheiner J., Appropriate phenotyping procedures for drug metabolizing enzymes and transporters in humans and their simultaneous use in the "cocktail" approach. Clin Pharmacol Ther. 2007; 81 (2): 270-283.
-
(2007)
Clin Pharmacol Ther.
, vol.81
, Issue.2
, pp. 270-283
-
-
Fuhr, U.1
Jetter, A.2
Kirchheiner, J.3
-
12
-
-
1642494659
-
"Cocktail" approaches and strategies in drug development: Valuable tool or flawed science?
-
Zhou H, Tong Z, McLeod JF,. "Cocktail" approaches and strategies in drug development: valuable tool or flawed science? J Clin Pharmacol. 2004; 44 (2): 120-134.
-
(2004)
J Clin Pharmacol.
, vol.44
, Issue.2
, pp. 120-134
-
-
Zhou, H.1
Tong, Z.2
McLeod, J.F.3
-
13
-
-
70849124428
-
Pharmacokinetic assessment of a five-probe cocktail for CYPs 1A2, 2C9, 2C19, 2D6 and 3A
-
Turpault S, Brian W, Van Horn R, et al., Pharmacokinetic assessment of a five-probe cocktail for CYPs 1A2, 2C9, 2C19, 2D6 and 3A. Br J Clin Pharmacol. 2009; 68 (6): 928-935.
-
(2009)
Br J Clin Pharmacol.
, vol.68
, Issue.6
, pp. 928-935
-
-
Turpault, S.1
Brian, W.2
Van Horn, R.3
-
14
-
-
0242382799
-
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."
-
Chainuvati S, Nafziger AN, Leeder JS, et al., 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." Clin Pharmacol Ther. 2003; 74 (5): 437-447.
-
(2003)
Clin Pharmacol Ther.
, vol.74
, Issue.5
, pp. 437-447
-
-
Chainuvati, S.1
Nafziger, A.N.2
Leeder, J.S.3
-
15
-
-
0023945481
-
The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis
-
Arnett FC, Edworthy SM, Bloch DA, et al., The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988; 31 (3): 315-324.
-
(1988)
Arthritis Rheum.
, vol.31
, Issue.3
, pp. 315-324
-
-
Arnett, F.C.1
Edworthy, S.M.2
Bloch, D.A.3
-
16
-
-
79960182099
-
Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study
-
Xu Z, Bouman-Thio E, Comisar C, et al., Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study. Br J Clin Pharmacol. 2011; 72 (2): 270-281.
-
(2011)
Br J Clin Pharmacol
, vol.72
, Issue.2
, pp. 270-281
-
-
Xu, Z.1
Bouman-Thio, E.2
Comisar, C.3
-
17
-
-
84874731986
-
Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects
-
Zhuang Y, Xu Z, de Vries DE, et al., Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects. Int J Clin Pharmacol Ther. 2013; 51 (3): 187-199.
-
(2013)
Int J Clin Pharmacol Ther.
, vol.51
, Issue.3
, pp. 187-199
-
-
Zhuang, Y.1
Xu, Z.2
De Vries, D.E.3
-
18
-
-
84875870177
-
Interleukins-12 and -23 do not alter expression or activity of multiple cytochrome P450 enzymes in cryopreserved human hepatocytes
-
Dallas S, Chattopadhyay S, Sensenhauser C, Batheja A, Singer M, Silva J., Interleukins-12 and -23 do not alter expression or activity of multiple cytochrome P450 enzymes in cryopreserved human hepatocytes. Drug Metab Dispos. 2013; 41 (4): 689-693.
-
(2013)
Drug Metab Dispos.
, vol.41
, Issue.4
, pp. 689-693
-
-
Dallas, S.1
Chattopadhyay, S.2
Sensenhauser, C.3
Batheja, A.4
Singer, M.5
Silva, J.6
-
19
-
-
84954401129
-
The cocktail approach and its utility in drug-drug interaction assessments for therapeutic proteins
-
Zhou H. Meibohm B. eds. Hoboken, Hoboken, NJ: Wiley
-
Jetter A, Fuhr U,. The cocktail approach and its utility in drug-drug interaction assessments for therapeutic proteins. In:, Zhou H, Meibohm B, eds. Drug-Drug Interactions for Therapeutic Biologics. Hoboken, Hoboken, NJ: Wiley; 2013: 111-118.
-
(2013)
Drug-Drug Interactions for Therapeutic Biologics
, pp. 111-118
-
-
Jetter, A.1
Fuhr, U.2
-
20
-
-
84880762256
-
A physiologically based pharmacokinetic modeling approach to predict disease-drug interactions: Suppression of CYP3A by IL-6
-
Machavaram KK, Almond LM, Rostami-Hodjegan A, et al., A physiologically based pharmacokinetic modeling approach to predict disease-drug interactions: suppression of CYP3A by IL-6. Clin Pharmacol Ther. 2013; 94 (2): 260-268.
-
(2013)
Clin Pharmacol Ther.
, vol.94
, Issue.2
, pp. 260-268
-
-
Machavaram, K.K.1
Almond, L.M.2
Rostami-Hodjegan, A.3
-
21
-
-
84905164026
-
A human anti-interleukin-6 monoclonal antibody: A randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy
-
Sirukumab
-
Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B., Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014; 73 (9): 1616-1625.
-
(2014)
Ann Rheum Dis
, vol.73
, Issue.9
, pp. 1616-1625
-
-
Smolen, J.S.1
Weinblatt, M.E.2
Sheng, S.3
Zhuang, Y.4
Hsu, B.5
-
22
-
-
79960606980
-
Effects of interleukin-6 (IL-6) and an anti-IL-6 monoclonal antibody on drug-metabolizing enzymes in human hepatocyte culture
-
Dickmann LJ, Patel SK, Rock DA, Wienkers LC, Slatter JG,. Effects of interleukin-6 (IL-6) and an anti-IL-6 monoclonal antibody on drug-metabolizing enzymes in human hepatocyte culture. Drug Metab Dispos. 2011; 39 (8): 1415-1422.
-
(2011)
Drug Metab Dispos.
, vol.39
, Issue.8
, pp. 1415-1422
-
-
Dickmann, L.J.1
Patel, S.K.2
Rock, D.A.3
Wienkers, L.C.4
Slatter, J.G.5
-
23
-
-
84865770458
-
Effects of interleukin 1beta (IL-1beta) and IL-1beta/interleukin 6 (IL-6) combinations on drug metabolizing enzymes in human hepatocyte culture
-
Dickmann LJ, Patel SK, Wienkers LC, Slatter JG,. Effects of interleukin 1beta (IL-1beta) and IL-1beta/interleukin 6 (IL-6) combinations on drug metabolizing enzymes in human hepatocyte culture. Curr Drug Metab. 2012; 13 (7): 930-937.
-
(2012)
Curr Drug Metab
, vol.13
, Issue.7
, pp. 930-937
-
-
Dickmann, L.J.1
Patel, S.K.2
Wienkers, L.C.3
Slatter, J.G.4
|