0155934 - QMS TCO RGT PI_FINAL_JP_03.10.11.indd
Contents
1. MV 9 INSBIS CE STE T HPD IC MEP I fa mE SIIL SE OEEO EDOD ET BX D 4 2 8 C 7 wed 7 28 20 5 Q e OMS2. Ah BECOMES MATERU BRI BaTiO BSIMERE AA CUES HBsAg HIV 1 2 HCV 7 gt 0 09 1 BOT ED HER
3. ee STIR Hea FE D AR F 12 QMS 4 E HH eee 10 ug mL Xid t
4. 6 EPRA JR o p QMS es 2 24 QMS nug mL
5. oe RHAI ELOD OES 8 eS CO ORB SEO SUE AED HOBBS lO LCA TF 60 g mL scalar 4 Ui LOO QMS LOQ LOQ 3 0 hg mL 3 0 100 ug mL GR
6. 2 Sah aie 150 6 78 BRA 79 RAVER SEO n area 911 2
7. c Lye z 10096 E 10 3 0 100 hg mL 14 as x100 hg mL pg mL 119 60 89 2 108 13 923 15 48 14 50 85 05 6 CLSI EP6 A 3 E ee 5 ay hg mL ug mL Gt I
8. 2 CV Rl 18 1 19 CLSI EP7 A222 QMS Z ARIMA 30 ug mL gt QMS 6
9. SO 3 1 PAD lt eae VTUEDBS 10 OMS DTA K2 SST OMS
10. R2 2 2 8 32 C A
11. REF 0374645 e OMS EF 0374652 A 1 x 1 0 mL e QMS REF 0374660 1 3 1x 2 0 mL 10 QMS Ik TERU EFIR 6 QMS A B C D E F 2 1 ppg ees A
12. 10 FB pg mL gt 12 g dL 28 70 96 71 21 mg dL 31 29 103 06 HAMA 1 31 08 102 37 LAIL 20 HAMA Human Anti Mouse Antibodies Fis pg mL 21 RMF OMS 30 ug mL hg mU 6 2 5 4 gz 01
13. Coe ET 22 hg mL hg mL ww om o 2 z g gp EF SS mw ET 25 hg mL D ot Detectable 26 1 Hunt AH Molloy RM Occolowitz JL Marconi GG Debono M Structure of the major glycopeptide of the teicoplanin complex J Am Chem Soc 1984 106 4891 4895 Parenti F Structure and mechanism of action of teicoplanin J Hosp Infect 1986 7 suppl Al A79 83 Somma S Gastaldo L Corti A Teicoplanin a new antibiotic from actinoplanes teichomyceticus nov sp Antimicrob Agents Chemother 1984 26 6 917 923 Personal communication with Eric W Lewis M D Marion Merrell Dow Inc Kansas City MO U S A Assandri A Bernareggi A Binding of Teicoplanin to human serum albumin Eur J Clin Pharmacol 1987 33 191 195 Antony KK Lewis EQ Kenny MT Dulworth JK Brackman MB Kuzma R Yuh L Eller MG Thompson GA Pharmacokin
14. HPLC 13 6 QMS IN 3 S7
15. i Si es eA REF 0374645 2 BOBS R1 1 1x21 mL R2 2 1x9 mL lt 5 0 0 05 lt 1 0 0 09 R1 R2 s s
16. GR Teicoplanin measurement in patients with renal failure comparison of fluorescence polarization immunoassay 28 microbiological assay and high performance liquid chromatograpic assay Ther Drug Monit 1991 13 6 511 517 4 Erickson RC Hildebrand AR Hoffman PF Gibson CB A sensitive bioassay for teicoplanin in serum in the presence or absence of other antibiotics Diagn Microbiol Infect Dis 1989 12 235 241 5 Kenny MT Dulworth JK Brackman MA Torney HL Gibson CB Hildebrand AR Weckbach LS Staneck JL Bioassay of teicoplanin in serum containing rifampin or a beta lactam antibiotic Diagn Microbiol Infect Dis 1989 12 449 454 6 Riva E Ferry N Cometti A Cuisinaud G Gallo GG Sassard J Determination of teicoplanin in human plasma and urine by affinity and reversed phase high performance liquid chromatography J Chromatog 1987 421 99 110 7 Dasgupta A Dean R Saldana S et al Absorption of therapeutic drugs by barrier gels in serum seprator blood collection tubes Am J Clin Pathol 1994 101 4 456 61 8 Targocid teicoplanin Powder for Injection Summary of Product Characteristics Guildford Surrey UK Sanofi Aventis November 2006 9 Tholen DW Kroll M Astles JR et al Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach Approved Guideline EP6 A Clinical and Laboratory Standards Institute CLSI Wayne PA 2003 29 20 Krouwer JS Tholen DW Garber CC
17. 0155934 0 2011 1 OMS EMEA OMS 1 800 232 3342 Microgenics vp LOT OJ MM At HRI stoma B2 E Wo CEIR eran REF ECIREP EU INGRED ud ah Microgenics GmbH i C Spitalhofstrasse 94 D 94032 Passau 0374645 EC REP SCIENTIFIC Tel 49 0 851 886 89 0 Fax 49 0 851 886 89 10 2011 Thermo Fisher Scientific Inc All rights res
18. erved QMS TEICO QMS CORRE REEMA TOES 12 3 7 4 90
19. et al Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition EP9 A2 Clinical and Laboratory Standards Institute CLSI Wayne PA 2002 21 Tholen DW Kallner A Kennedy JW et al Evaluation of Precisio Performance of Quantitative Measurement Methods Approved Guideline Second Edition EP5 A2 Clinical and Laboratory Standards Institute CLSI Wayne PA 2004 22 McEnroe RJ Burritt MF Powers DM et al Interference Testing in Clinical Chemistry Approved Guideline Second Edition EP7 A2 Clinical and Laboratory Standards Institute CLSI Wayne PA 2005 30 Thermo Fisher Scientific Inc Microgenics Corporation 46360 Fremont Blvd Fremont CA 94538 6406 USA 31
20. etics and bioavailability of a new formulation of teicoplanin following intravesnous and intramuscular administration to humans JPharm Sciences 1991 80 6 605 607 Falcoz C Ferry N Pozet N Cuisinaud G Zech PY Sassard J Pharmacokinetics of teicoplanin in renal failure Antimicrob Agents Chemother 1987 31 8 1255 1262 27 8 Derbyshire N Webb DB Roberts D Glew D Williams JD Pharmacokinetics of teicoplanin in subjects with varying degrees of renal vunction J Antimicrob Chemother 1989 23 6 869 876 9 Domart Y Pierre C Clair B Garaud JJ Regnier B Gilbert C Pharmacokinetics of teicoplanin in critically ill patients with various degrees of renal impairment Antimicrob Agents Chemother 1987 31 10 1600 1604 10 Potel G Moutet J Bernareggi A LeNormand Y Meigner M Baron D Pharmacokinetics of teicoplanin in burn patients Scand J Infect Dis 1990 72 suppl 29 34 11 Rybak MJ Lerner SA Levine DP Albrecht LM McNeil PL Thompson GA Kenny MT Yuh L Teicoplanin pharmacokinetics in intravenous drug abusers being treated for bacterial endocarditis Antimicrob Agents Chemother 1991 35 4 696 700 12 Bibler MR Frame PT Hagler DN Bode RB Staneck JL Thamlikitkul V Harris JE Haregewoin A Bullock WE Jr Clinical evaluation of efficacy pharmacokinetics and safety of teicoplanin for serious gram positive infections Antimicrob Agents Chemother 1987 31 2 207 212 13 Awni WM St Peter WL Guay DRP Kenny MT Matzke
21. t Tal T a REREN 16 3 hg mL pg mL peek a csi 7 EP9 A220 QMS Innofuor 100 2 RM Bablok ent cl ps mi Pog CU nee cl QMS vs 0 93 0 29 0 94 0 17 Innofluor 100 0 89 0 96 0 60 1 17 0 90 0 97 0 50 0 76 0 98 CLSI EP9 A2 2 3 1 2 2 20
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