Interferon beta assessment in non-Chinese and Chinese subjects: Pharmacokinetics and pharmacodynamic activity of an endogenous cytokine are not race dependent

Journal of Clinical Pharmacology

Volumn 54, Issue 10, 2014, Pages 1153-1161

  Rogge, Mark C ^a   Liu, Yun ^b   Galluppi, Gerald R ^a  

^a BIOGEN   (United States)

^b Shanghai Xuhui Central Hospital   (China)

Author keywords

Chinese; cytokine; interferon; pharmacodynamics; pharmacokinetics

Indexed keywords

BETA1A INTERFERON; CYTOKINE; NEOPTERIN; BETA INTERFERON; IMMUNOLOGICAL ADJUVANT;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHINESE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN EXPERIMENT; LIVER FUNCTION TEST; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL MODEL; CLINICAL TRIAL; INTRAMUSCULAR DRUG ADMINISTRATION; YOUNG ADULT;

ADJUVANTS, IMMUNOLOGIC; ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; INJECTIONS, INTRAMUSCULAR; INTERFERON-BETA; MALE; MODELS, BIOLOGICAL; YOUNG ADULT;

EID: 84922206765     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.311     Document Type: Article

References (13)

1. Ling J, Lyn S, Xu Z, et al. Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects. J Clin Pharmacol. 2010; 50 (7): 792-802.
2. Uenaka K, Nakano M, Willis BA, et al. Comparison of pharmacokinetics, pharmacodynamics, safety, and tolerability of the amyloid β monoclonal antibody solanezumab in Japanese and white patients with mild to moderate Alzheimer disease. Clin Neuropharmacol. 2012; 35 (1): 25-29.
3. Shirao K, Yoshino T, Boku N, et al. A phase I escalating single-dose and weekly fixed-dose study of cetuximab pharmacokinetics in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2009; 64 (3): 557-564.
4. Doi T, Ohtsu A, Tahara M, et al. Safety and pharmacokinetics of panitumumab in Japanese patients with advanced solid tumors. Int J Clin Oncol. 2009; 14 (4): 307-314.
5. Yasuda SU, Zhang L, Huang SM,. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther. 2008; 84 (3): 417-423.
6. Mager DE,. Target-mediated drug disposition and dynamics. Biochem Pharmacol. 2006; 72 (1): 1-10.
7. Thomas C, Moraga I, Levin D, et al. Structural linkage between ligand discrimination and receptor activation by type I interferons. Cell. 2011; 146 (4): 621-632.
8. Wachter H, Fuchs D, Hausen A, Reibnegger G, Werner ER,. Neopterin as marker for activation of cellular immunity: Immunologic basis and clinical application. Adv Clin Chem. 1989; 27: 81-141.
9. Fuchs D, Weiss G, Wachter H,. Neopterin, biochemistry and clinical use as a marker for cellular immune reactions. Int Arch Allergy Immunol. 1993; 101 (1): 1-6.
10. de Weerd NA, Samarajiwa SA, Hertzog PJ,. Type I interferon receptors: biochemistry and biological functions. J Biol Chem. 2007; 282 (28): 20053-22057.
11. Zhou H, Tsukamoto Y, Davis HM,. Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies? J Clin Pharmacol. 2012; 52 (8): 1273-1276.
12. Gu N, Yi S, Kim TE, et al. Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers. Clin Ther. 2011; 33 (12): 2029-2037.
13. Zhang D, Wang Z, Zhao X, Lu W, Gu J, Cui Y,. Pharmacokinetics, pharmacodynamics, tolerability and safety of single doses of bivalirudin in healthy Chinese subjects. Biol Pharm Bull. 2011; 34 (12): 1841-1848.