SEARCH

SEARCH BY CITATION

References

  • 1
    Welage LS, Kirking DM, Ascione FJ, Gaither CA. Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc (Wash) 2001; 41: 856.
  • 2
    Cuffari C, Hunt S, Bayless TM. Enhanced bioavailability of azathioprine compared to 6-mercaptopurine therapy in inflammatory bowel disease: correlation with treatment efficacy. Aliment Pharmacol Ther 2000; 14: 1009.
  • 3
    Haroldson JA, Somerville KT, Carlson S, Hanson J, Emery RW, Lake KD. A retrospective assessment of safety, efficacy, and pharmacoeconomics of generic azathioprine in heart-transplant recipients. J Heart Lung Transplant 2001; 20: 372.
  • 4
    Nightingale SL, Morrison JC. Generic drugs and the prescribing physician. JAMA 1987; 258: 1200.
  • 5
    Henderson J, Dighe S, Williams R. Subject selection and management in bioequivalence studies. Clin Res Reg Aff 1992; 9: 71.
  • 6
    Gleiter CH, Gundert-Remy U. Bioinequivalence and drug toxicity. How great is the problem and what can be done? Drug Saf 1994; 11: 1.
  • 7
    Rheinstein PH. The generic drug approval process. Am Fam Physician 1993; 48: 1357.
  • 8
    Nation RL, Sansom LN. Bioequivalence requirements for generic products. Pharmacol Ther 1994; 62: 41.
  • 9
    Skelly JP. Bioavailability and bioequivalence. J Clin Pharmacol 1976; 16: 539.
  • 10
    Patnaik R, Lesko LJ, Chan K, Williams RL. Bioequivalence assessment of generic drugs. an American point of view. Eur J Drug Metab Pharmacokinet 1996; 21: 159.
  • 11
    Christians U, First MR, Benet LZ. Recommendations for bioequivalence testing of cyclosporine generics revisited. Ther Drug Monit 2000; 22: 330.
  • 12
    Garbe E, Rohmel J, Gundert-Remy U. Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol 1993; 45: 1.
  • 13
    Federal Food, Drug, Cosmetic Act 21USC, 355 (j)&(B).
  • 14
    Marzo A, Balant LP. Bioequivalence. An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products. Arzneimittelforschung 1995; 45: 109.
  • 15
    Bioavailability and Bioequivalence Requirements. 21 CFR 320.163, 2001.
  • 16
    Benet LZ, Goyan JE. Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 1995; 15: 433.
  • 17
    Min DI, Hwang GC, Bergstrom S et al.. Bioavailability and patient acceptance of cyclosporine soft gelatin capsules in renal allograft recipients. Ann Pharmacother 1992; 26: 175.
  • 18
    Zehnder C, Beveridge T, Nuesch E, Abisch A, Thiel G. Cyclosporine A capsules: bioavailability and clinical acceptance study in renal transplant patients. Transplant Proc 1988; 20 (2 Suppl. 2): 641.
  • 19
    Bleck JS, Nashan B, Christians U, Schottmann R, Wonigeit K, Sewing KF. Single dose pharmacokinetics of ciclosporin and its main metabolites after oral ciclosporin as oily solution or capsule. Arzneimittelforschung 1990; 40: 62.
  • 20
    Nashan B, Bleck J, Wonigeit K et al.. Effect of the application form of cyclosporine on blood levels: comparison of oral solution and capsules. Transplant Proc 1988; 20 (2 Suppl. 2): 637.
  • 21
    Hilbrands LB, Hoitsma AJ, Van Den Berg JW, Koene RA. Cyclosporin A blood levels during use of cyclosporin as oral solution or in capsules: comparison of pharmacokinetic parameters. Transplant Int 1991; 4: 125.
  • 22
    Bennett WM, Olyaei AJ. Pharmacoeconomics of immunosuppressive agents in renal transplant recipients. Transplant Proc 1999; 31 (3A (Suppl.): 6S.
  • 23
    Coukell AJ, Plosker GL. Cyclosporin microemulsion (Neoral). A pharmacoeconomic review of its use compared with standard cyclosporin in renal and hepatic transplantation. Pharmacoeconomics 1998; 14: 691.
  • 24
    Alloway RR. Generic immunosuppressant use in solid organ transplantation. Transplant Proc 1999; 31 (3A (Suppl.): 2S.
  • 25
    Roza A, Tomlanovich S, Merion R et al.. Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation. Transplantation 2002; 74: 1013.
  • 26
    Tomlanovich S, Pollack R, Roza A et al.. A pharmacokinetic conversion study of Abbott cyclosporine and NEORAL in stable renal transplant recipients. North Chicago , IL : Abbott Laboratories, Inc. , 1999; 60064: 99J–03199J–8028.
  • 27
    Lindholm A, Welsh M, Rutzky L, Kahan BD. The adverse impact of high cyclosporine. Clearance rates on the incidences of acute rejection and graft loss. Transplantation 1993; 55: 985.
  • 28
    Merion RM, White DJ, Thiru S, Evans DB, Calne RY. Cyclosporine: five years' experience in cadaveric renal transplantation. N Engl J Med 1984; 310: 148.
  • 29
    Neylan JF. Immunosuppressive therapy in high-risk transplant patients: dose-dependent efficacy of mycophenolate mofetil in African-American renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group . Transplantation 1997; 64: 1277.
  • 30
    Watkins PB. The barrier function of CYP3A4 and P-glycoprotein in the small bowel. Adv Drug Deliv Rev 1997; 27: 161.
  • 31
    Malhotra S, Bailey DG, Paine MF, Watkins PB. Seville orange juice–felodipine interaction: comparison with dilute grapefruit juice and involvement of furocoumarins. Clin Pharmacol Ther 2001; 69: 14.
  • 32
    Watkins P, Leichtman A. The molecular basis of cyclosporin a metabolism, pharmacokinetics and drug interactions. Graft 1999; 2: 177.
  • 33
    Kasiske BL, Cohen D, Lucey MR, Neylan JF. Payment for immunosuppression after organ transplantation: American Society of Transplantation. JAMA 2000; 283: 2445.
  • 34
    Burckart G, Venkataramanan R, Starzl T, Ptachcinski R, Gartner C, Rosenthal T. Cyclsoporine clearance in children following organ transplantation. J Clin Pharmacol 1985; 24: 412.
  • 35
    Venkataramanan R, Burckhart GJ, Ptachcinski RJ. Pharmacokinetics and monitoring of cyclosporine following orthotopic liver transplantation. Semin Liver Dis 1985; 5: 357.
  • 36
    Yee GC, Lennon TP, Gmur DJ, Kennedy MS, Deeg HJ. Age-dependent cyclosporine: pharmacokinetics in marrow transplant recipients. Clin Pharmacol Ther 1986; 40: 438.
  • 37
    Hoyer PF, Brodehl J, Ehrich JH, Offner G. Practical aspects in the use of cyclosporin in paediatric nephrology. Pediatr Nephrol 1991; 5: 630.
  • 38
    Isaacs RB. Optimal transplant immunosuppression: a case of the haves and have nots? Am J Kidney Dis 2001; 37: 160.