Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model

PLoS ONE

Volumn 5, Issue 5, 2010, Pages

  Zuluaga, Andres F ^a   Agudelo, Maria ^a   Cardeño, John J ^a   Rodriguez, Carlos A ^a   Vesga, Omar ^a,b  

^a UNIVERSIDAD DE ANTIOQUIA   (Colombia)

^b Hospital Universitario San Vicente de Paul   (Colombia)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; GENTAMICIN; ANTIINFECTIVE AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANTIBIOTIC SENSITIVITY; AREA UNDER THE CURVE; ARTICLE; BACTERIAL INFECTION; COLONY FORMING UNIT; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MOUSE; NONHUMAN; PHARMACODYNAMICS; ANIMAL; ANTIBODY SPECIFICITY; DISEASE MODEL; DRUG EFFECT; MICROBIOLOGICAL EXAMINATION; MICROBIOLOGY; NEUTROPENIA; PATHOLOGY; PHARMACOKINETICS; REPRODUCIBILITY; SURVIVAL; THIGH;

ANIMALIA;

ANIMALS; ANTI-INFECTIVE AGENTS; BACTERIAL INFECTIONS; DISEASE MODELS, ANIMAL; DRUGS, GENERIC; GENTAMICINS; MICE; MICROBIAL SENSITIVITY TESTS; NEUTROPENIA; ORGAN SPECIFICITY; REPRODUCIBILITY OF RESULTS; SURVIVAL ANALYSIS; THERAPEUTIC EQUIVALENCY; THIGH;

EID: 77954382865     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0010744     Document Type: Article

References (49)

1. Henry D, Lexchin J (2002) The pharmaceutical industry as a medicines provider. Lancet 360: 1590; 1-1595. S0140-6736(02)11527-3 [pii];10.1016/ S0140-6736(02)11527-3 [doi].
2. Kirking DM, Ascione FJ, Gaither CA, Welage LS (2001) Economics and structure of the generic pharmaceutical industry. J Am Pharm Assoc (Wash) 41: 578-584.
3. Blossom DB, Kallen AJ, Patel PR, Elward A, Robinson L, et al. (2008) Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med 359: 2674-2684. NEJMoa0806450 [pii];10.1056/NEJMoa0806450 [doi].
4. Feldschreiber P (2009) Public health issues with counterfeit medicines. Clin Med 9: 63-64.
5. Mastoraki E, Michalopoulos A, Kriaras I, Mouchtouri E, Falagas M, et al. (2008) Incidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroxime. J Infect 56: 35-39.
6. Katzung BG (2007) Basic & clinical pharmacology. New York: McGraw-Hill Medical.
7. Henderson JD, Esham RH (2001) Generic substitution: issues for problematic drugs. South Med J 94: 16-21.
8. Meredith P (2003) Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 25: 2875-2890.
9. Nation RL, Sansom LN (1994) Bioequivalence requirements for generic products. Pharmacol Ther 62: 41-55. 0163-7258(94)90004-3 [pii].
10. Strom BL (1987) Generic drug substitution revisited. N Engl J Med 316: 1456-1462.
11. Apte SP, Ugwu SO (2003) A Review and Classification of Emerging Excipients in Parental Medications. Pharmaceutical Technology Europe 15: 45-55.
12. Dodd S, Besag FM (2009) Lessons from contaminated heparin. Curr Drug Saf 4: 1.
13. Roy J (2002) Pharmaceutical impurities-a mini-review. AAPS PharmSciTech 3: E6.
14. Welage LS, Kirking DM, Ascione FJ, Gaither CA (2001) Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc (Wash) 41: 856-867.
15. Gonzalez LS, III, Spencer JP (1998) Aminoglycosides: a practical review. Am Fam Physician 58: 1811-1820.
16. Rheinstein PH (1990) Therapeutic inequivalence. Drug Saf 5 Suppl 1: 114-119.
17. Clinical and Laboratory Standards Institute (2003) Methods for dilution antimicrobial susceptibility test for bacteria that grow, approved standard M7- A6. Wayne: Clinical and Laboratory Standards Institute (CLSI).
18. Weinstein MJ, Luedemann GM, Oden EM, Wagman GH, Rosselet JP, et al. (1963) Gentamicin, a new antibiotic complex from Micromonospora. J Med Chem 6: 463-464.
19. Clinical and Laboratory Standards Institute (2006) Performance standards for antimicrobial susceptibility testing, approved standard M100-S16. Wayne, PA: Clinical and Laboratory Standards Institute (CLSI).
20. Zuluaga AF, Salazar BE, Rodriguez CA, Zapata AX, Agudelo M, Vesga O (2006) Neutropenia induced in outbred mice by a simplified low-dose cyclophosphamide regimen: characterization and applicability to diverse experimental models of infectious diseases. BMC Infect Dis 6: 55.
21. Craig WA (1998) Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 26: 1-10.
22. Gerber AU, Craig WA, Brugger HP, Feller C, Vastola AP, et al. (1983) Impact of dosing intervals on activity of gentamicin and ticarcillin against Pseudomonas aeruginosa in granulocytopenic mice. J Infect Dis 147: 910-917.
23. Brashier MK, Geor RJ, Ames TR, O'Leary TP (1998) Effect of intravenous calcium administration on gentamicin-induced nephrotoxicosis in ponies. Am J Vet Res 59: 1055-1062.
24. Singh YN, Harvey AL, Marshall IG (1978) Antibiotic-induced paralysis of the mouse phrenic nerve-hemidiaphragm preparation, and reversibility by calcium and by neostigmine. Anesthesiology 48: 418-424.
25. Zuluaga AF, Agudelo M, Rodriguez CA, Vesga O (2009) Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics. BMC Clin Pharmacol 9: 1. 1472-6904-9-1 [pii];10.1186/1472-6904-9-1 [doi].
26. Tracy M, Wanahita A, Shuhatovich Y, Goldsmith EA, Clarridge JE, III, et al. (2001) Antibiotic susceptibilities of genetically characterized Streptococcus milleri group strains. Antimicrob Agents Chemother 45: 1511-1514. 10.1128/ AAC.45.5.1511-1514.2001 [doi].
27. Toutain PL, Lees P (2004) Integration and modelling of pharmacokinetic and pharmacodynamic data to optimize dosage regimens in veterinary medicine. J Vet Pharmacol Ther 27: 467-477. JVP613 [pii];10.1111/j.1365-2885.2004.00613.x [doi].
28. Lees P, Cunningham FM, Elliott J (2004) Principles of pharmacodynamics and their applications in veterinary pharmacology. J Vet Pharmacol Ther 27: 397-414. JVP620 [pii];10.1111/j.1365-2885.2004.00620.x [doi].
29. Glantz SA (2006) Primer of Biostatistics McGraw-Hill Companies, Inc. 520 p.
30. Dupont WD, Plummer WD (1997) PS power and sample size program available for free on the internet. Controlled Cllin Trials 18: 274.
31. British Pharmaceutical Society (2007) British Pharmacopoeia British Pharmacopoeia Commission.
32. Food and Drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation. -22.
33. U.S.Department of Health and Human Services, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) (2001) Guidance for industry. Statistical Approach to Establishing Bioequivalence.
34. Generic Drugs (2002) Med Lett Drugs Ther 44: 89-90.
35. Dettelbach HR (1986) A time to speak out on bioequivalence and therapeutic equivalence. J Clin Pharmacol 26: 307-308.
36. Jones RN, Fritsche TR, Moet GJ (2008) In vitro potency evaluations of various piperacillin/tazobactam generic products compared with the contemporary branded (Zosyn, Wyeth) formulation. Diagn Microbiol Infect Dis 61: 76-79. S0732-8893(07)00598-6 [pii];10.1016/j.diagmicrobio.2007.12.010 [doi].
37. Pollack M (1984) The virulence of Pseudomonas aeruginosa. Rev Infect Dis 6 Suppl 3: S617-S626.
38. Rodriguez CA, Agudelo M, Cataño JC, Zuluaga AF, Vesga O (2009) Potential Therapeutic Failure of Generic Vancomycin in a Liver Transplant Patient with MRSA Peritonitis and Bacteremia. J Infect 59: 277-80. Epub 2009 Aug 19. 10.1016/j.jinf.2009.08.005.
39. Ammerlaan H, Seifert H, Harbarth S, Brun-Buisson C, Torres A, et al. (2009) Adequacy of antimicrobial treatment and outcome of Staphylococcus aureus bacteremia in 9 Western European countries. Clin Infect Dis 49: 997-1005. 10.1086/605555 [doi].
40. Moellering RC, Jr. (2009) What is inadequate antibacterial therapy? Clin Infect Dis 49: 1006-1008. 10.1086/605556 [doi].
41. Jia H (2008) Regulators scramble to tighten loopholes after heparin debacle. Nat Biotechnol 26: 477-478. nbt0508-477 [pii];10.1038/nbt0508-477 [doi].
42. United States Pharmacopeial Convention (2002) The Pharmacopoeia of the United States of America. Rockville, MD.: United States Pharmacopeia Convention. 1084 p.
43. Akers MJ (2002) Excipient-drug interactions in parenteral formulations. J Pharm Sci 91: 2283-2300. 10.1002/jps.10154 [doi].
44. Crowley PJ (1999) Excipients as stabilizers. Pharm Sci Technolo Today 2: 237-243. S1461534799001583 [pii].
45. Allen LV, Jr. (2008) Dosage form design and development. Clin Ther 30: 2102-2111. S0149-2918(08)00409-8 [pii];10.1016/j.clinthera.2008.11.015 [doi].
46. Duenas-Laita A, Pineda F, Armentia A (2009) Hypersensitivity to generic drugs with soybean oil. N Engl J Med 361: 1317-1318. 361/13/1317 [pii];10.1056/ NEJMc0904562 [doi].
47. Napke E, Stevens DG (1984) Excipients and additives: hidden hazards in drug products and in product substitution. Can Med Assoc J 131: 1449-1452.
48. Wang D, Notari RE (1994) Cefuroxime hydrolysis kinetics and stability predictions in aqueous solution. J Pharm Sci 83: 577-581.
49. Recht MI, Douthwaite S, Puglisi JD (1999) Basis for prokaryotic specificity of action of aminoglycoside antibiotics. EMBO J 18: 3133-3138. 10.1093/emboj/18.11.3133 [doi]