Pharmacokinetic/pharmacodynamic integration in drug development and dosage-regimen optimization for veterinary medicine

Peck CC. Rationale for the effective use of pharmacokinetics and pharmacodynamics in early drug development. In: Yacobi A, Skelly JP, Shah VP, et al. eds. Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development. New York, NY: Plenum Press; 1993. 1–5.

Reigner BG, Williams PE, Patel IH, et al. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development: experience within Hoffmann La Roche. Clin Pharmacokinet. 1997; 33(2): 142–152.

Peck CC, Barr WH, Benet LZ, et al. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Int J Pharm. 1992; 82: 9–19.

Derendorf H, Lesko LJ, Chaikin P, et al. Pharmacokinetic/pharmacodynamic modeling in drug research and development. J Clin Pharmacol. 2000; 40(12 pt 2): 1399–1418.

Holford NH, Sheiner LB. Pharmacokinetic and pharmacodynamic modeling in vivo. CRC Crit Rev Bioeng. 1981; 5(4): 273–322.

Riviere JE. Comparative Pharmacokinetics: Principles, Techniques and Applications. Ames, Iowa: Iowa State University Press, 1999.

Holford NH, Sheiner LB. Kinetics of pharmacologic response. Pharmacol Ther. 1982; 16(2): 143–166.

Campbell DB. The use of kinetic-dynamic interactions in the evaluation of drugs. Psychopharmacology. 1990; 100(4): 433–450.

Holford NHG, Ludden TM. Time course of drug effect. In: Welling PG, Balant LP, eds. Pharmacokinetics of Drugs. Vol. 110. Berlin, Germany: Springer-Verlag: 1994: 333–352.

Danhof M, Mandema JW. Modeling of relationships between pharmacokinetics and pharmacodynamics. In: Welling PG, Tse FLS, eds. Pharmacokinetics: Regulatory, Industrial, Academic Perspectives. New York, NY: Marcel Dekker, 1988: 139–174.

Derendorf H, Hochhaus G. Handbook of Pharmacokinetic/Pharmacodynamic Correlation. Washington, DC: CRC Press; 1995.

VanBoxtel CJ, Holford NHG, Danhof M. The In Vivo Study of Drug Action: Principles and Applications of Kinetic-Dynamic Modelling. Amsterdam. The Netherlands: Elsevier, 1992.

Yacobi A, Skelly JP, Shah VP, Benet LZ. Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development. New York, NY: Plenum Press; 1993.

Sheiner LB, Hashimoto Y, Beal SL. A sunulation study comparing designs for dose ranging. Stat Med. 1991; 10(3): 303–321.

Källen A, Larsson P. Dose response studies: how do we make them conclusive? Stat Med. 1999; 18(6): 629–641.

Filloon TG. Estimating the minimum therapeutically effective dose of a compound via regression modelling and percentile estimation. Stat Med. 1995; 149(9–10): 925–932; discussion 933.

Temple R. Dose response and registration of new drugs. In: Lasagna SE, Naranjo CA, eds. Dose Response Relationships in Clinical Pharmacology. Amsterdam, The Netherlands: Elsevier; 1989: 145–167.

Toutain PL, Lefebvre HP, King JN. Benazeprilat disposition and effect in dogs revisited with a pharmacokinetic/pharmacodynamic modeling approach. J Pharmacol Exp Ther: 2000; 292(3): 1087–1093.

Toutain PL, Cester CC, Haak T, Laroute V. A pharmacokinetic/pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog. J Vet Pharmacol Ther. 2001; 24(1): 43–55.

Levy G. Predicting effective drug concentrations for individual patients: determinants of pharmacodynamic variability. Clin Pharmacokinet. 1998; 34(4): 323–333.

Aarons L. Population pharmacokinetics: theory and practice. Br J Clin Pharmacol. 1991; 32(6): 669–670.

Martin-Jimenez T, Riviere JE. Population pharmacokinetics in veterinary medicine: potential use for therapeutic drug monitoring and prediction of tissue residues. J Vet Pharmacol Ther. 1998; 21(3): 167–189.

Toutain PL, DelCastillo JRE, Bousquet-Melou A. The pharmacokinetic-pharmacodynamic (PK/PD) approach to a rational dosage regimen for antibiotics. Res Vet Sci. In press.

Reilly JJ, Workman P. Normalisation of anti-cancer drug dosage using body weight and surface area: is it worthwhile? A review of theoretical and practical considerations. Cancer Chemother Pharmacol. 1993; 32(6): 411–418.

Arrington KA, Legendre AM, Tabeling GS, Frazier DL. Comparison of body surface area-based and weight-based dosage protocols for doxorubicin administration in dogs. Am J Vet Res. 1994; 55(11): 1587–1592.

Sawyer M, Ratain MJ. Body surface area as a determinant of pharmacokinetics and drug dosing. Invest New Drug. 2001; 19(2): 171–177.

Martinez MN, Riviere JE, Koritz GD. Review of the first interactive workshop on professional flexible labeling. J Am Vet Med Assoc. 1995; 207(7): 865.

Stanski DR, Greenblatt DJ, Lowenstein E. Kinetics of intravenous and intramuscular morphine. Clin Pharmacol Ther. 1978; 24(1): 52–59.

Barnhart MD, Hubbell JA, Muir WW, Sams RA, Bednarski RM. Pharmacokinetics, pharmacodynamics, and analgesic effects of morphine after rectal, intramuscular, and intravenous administration in dogs. Am J Vet Res. 2000; 61(1): 24–28.

Combie JD, Nugent TE, Tobin T. Pharmacokinetics and protein binding of morphine in horses. Am J Vet Res. 1983; 44(5): 870–874.

Baggot JD, Davis LE. Species differences in plasma protein binding of morphine and codeine. Am J Vet Res. 1973; 34(4): 571–574.

MacKichan JJ, Hink WF. High-performance liquid chromatographic determination of CGA-184699 (lufenuron) in dog and cat blood. J Liq Chromatogr. 1993; 16(12): 2595–2604.

Blagburn BL, Vaughan JL, Butler JM, Parks SC. Dose titration of an injectable formulation of lufenuron in cats experimentally infested with fleas. Am J Vet Res. 1999; 60(12): 1513–1515.

Knapp DW, Chan TC, Kuczek T, Reagan WJ, Park B. Evaluation of in vitro cytotoxicity of nonsteroidal anti-inflammatory drugs against canine tumor cells. Am J Vet Res. 1995; 56(6): 801–805.

Page RL, McEntee MC, George SL, et al. Pharmacokinetic and phase I evaluation of carboplatin in dogs. J Vet Intern Med. 1993; 7(4): 235–240.

Rassnick KM, Ruslander DM, Cotter SM, et al. Use of carboplatin for treatment of dogs with malignant melanoma: 27 cases (1989–2000). J Am Vet Med Assoc. 2001; 218(9): 1444–1448.

Holford NHG. Parametric models of the time course of drug action. In: vanBoxtel CJ, Holford NHG, Danhof M, eds. The In Vivo Study of Drug Action. Amsterdam, The Netherlands: Elsevier; 1992: 61–69.

Rolan P. The contribution of clinical pharmacology surrogates and models to drug development_a critical appraisal. Br J Clin Pharmacol. 1997; 44(3): 219–225.

Colburn WA. Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development. J Clin Pharmacol. 2000; 40(12 pt 2): 1419–1427.

Anonymous. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001; 69(3): 89–95.

Dingemanse J. Kinetics and dynamics of drug effects on the nervous system: an introduction. In: vanBoxtel CJ, Holford NHG, Danhof M, eds. The In Vivo Study of Drug Action. Amsterdam, The Netherlands: Elsevier; 1992: 113–129.

Toutain PL, Lefebvre HP, Laronte V. New insights on effect of kidney insufficiency on disposition of angiotensin-converting enzyme inhibitors: case of enalapril and benazepril in dogs. J Pharmacol Exp Ther. 2000; 292(3): 1094–1103.

Hammarlund-Udenaes M, Benet LZ. Furosemide pharmacokinetics and pharmacodynamics in health and disease_an update. J Pharmacokinet Biopharm. 1989; 17(1): 1–46.

Landoni MF, Lees P. Pharmacokinetic/pharmacodynamic modelling of non-steroidal anti-inflammatory drugs. J Vet Pharmacol Ther. 1997; 20(suppl 1): 118–120.

Lees P, Aliabadi FS. Rational dosing of antimicrobial drugs: animals versus humans. Int J Antimicrob Agents. In press.

Bennett DG. Clinical pharmacology of ivermectin. J Am Vet Med Assoc. 1986; 189(1): 100–104.

Karlsson MO, Molnar V, Bergh J, Freijs A, Larsson R. A general model for time-dissociated pharmacokinetic-pharmacodynamic relationships exemplified by paclitaxel myelosuppression. Clin Pharmacol Ther. 1998; 63(1): 11–25.

Aliabadi FS, Lees P. Pharmacokinetic/pharmacodynamic integration of danofloxacin in the calf. Res Vet Sci. In press.

Nies AS, Spielberg SP. Principles of therapeutics. In: Hardman JG, Gilman AG, Limbird LE, eds. Goodman & Gilman's, The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill Health Profession Division; 1996.

Black JW, Leff P. Operational models of pharmacological agonism. Proc R Soc Lond B Biol Sci. 1983; 220(1219): 141–162.

Kenakin T. Pharmacologic Analysis of Drug-Receptor Interaction. Philadelphia, PA: Lippincott-Raven; 1997.

Kenakin TP. The quantification of relative efficacy of agonists. J Pharmacol Methods. 1985; 13(4): 281–308.

Schoemaker RC, van Gerven JM, Cohen AF. Estimating potency for the Emax-model without attaining maximal effects. J Pharmacokinet Biopharm. 1998; 26(5): 581–583.

Toutain PL, Cester CC, Haak T, Metge S. Pharmacokinetic profile and in vitro selective cyclooxygenase-2 inhibition by nimesulide in the dog. J Vet Pharmacol Ther. 2001; 24(1): 35–42.

Toutain PL, Autefage A, Legrand C, Alvinerie M. Plasma concentrations and therapeutic efficacy of phenylbutazone and fluxinin meglumine in the horse: pharmacokinetic/pharmacodynamic modelling. J Vet Pharmacol Ther. 1994; 17(6): 459–469.

Mattie H. Antibiotic efficacy in vivo predicted by in vitro activity. Int J Antimicrob Agents. 2000; 14(2): 91–98.

Zhi J, Nightingale CH, Quintiliani R. A pharmacodynamic model for the activity of antibiotics against microorganisms under nonsaturable conditions. J Pharm Sci. 1986; 75(11): 1063–1067.

Mager DE, Jusko WJ. Pharmacodynamic modeling of time-dependent transduction systems. Clin Pharmacol Ther. 2001; 70(3): 210–216.

Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther. 1979; 25(3): 358–371.

Qiao GL, Fung KF. Pharmacokinetic-pharmacodynamic modelling of meperidine in goats, II: modelling. J Vet Pharmacol Ther. 1994; 17(2): 127–134.

Jusko WJ. Conceptualization of drug distribution to a hypothetical pharmacodynamic effect compartment. Clin Pharmacol Ther. 1993; 54(1): 112–113.

Shafer SL, Varvel JR, Gronert GA. A comparison of parametric with semiparametric analysis of the concentration versus effect relationship of metocurine in dogs and pigs. J Pharmacokinet Biopharm. 1989; 17(3): 291–304.

Unadkat JD, Bartha F, Sheiner LB. Simultaneous modeling of pharmacokinetics and pharmacodynamics with nonparametric kinetic and dynamic models. Clin Pharmacol Ther. 1986; 40(1): 86–93.

Fuseau E, Sheiner LB. Simultaneous modeling of pharmacokinetics and pharmacodynamics with a nonparametric pharmacodynamic model. Clin Pharmacol Ther. 1984; 35(6): 733–741.

Dayneka NL, Garg V, Jusko WJ. Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm. 1993; 21(4): 457–478.

Jusko WJ, Ko HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther. 1994; 56(4): 406–419.

Sharma A, Jusko WJ. Characterization of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm. 1996; 24(6): 611–635.

Gobburu JV, Jusko WJ. Role of dosage regimen in controlling indirect pharmacodynamic responses. Adv Drug Deliv Rev. 2001; 46(1–3): 45–57.

Levy G. Mechanism-based pharmacodynamic modeling. Clin Pharmacol Ther. 1994; 56(4): 356–358.

Hop CE, Wang Z, Chen Q, Kwei G. Plasma-pooling methods to increase throughput for in vivo pharmacokinetic screening. J Pharm Sci. 1998; 87(7): 901–903.

Allen MC, Shah TS, Day WW. Rapid determination of oral pharmacokinetics and plasma free fraction using cocktail approaches: methods and application. Pharm Res. 1998; 15(1): 93–97.

Rowland M, Tozer TN. Clinical Pharmacokinetics: Concepts and Applications. London, UK: Williams & Wilkins; 1995.

Landoni MF, Lees P. Pharmacokinetics and pharmacodynamics of ketoprofen enantiomers in calves. Chirality. 1995; 7(8): 586–597.

Landoni MF, Cunningham FM, Lees P. Pharmacokinetics and pharmacodynamics of tolfenamic acid in calves. Res Vet Sci. 1996; 61(1): 26–32.

Landoni MF, Cunningham FM, Lees P. Determination of pharmacokinetics and pharmacodynamics of flunixin in calves by use of pharmacokinetic/pharmacodynamic modeling. Am J Vet Res. 1995; 56(6): 786–794.

Lees P, McKellar Q, May SA, Ludwig B. Pharmacodynamics and pharmacokinetics of carprofen in the horse. Equine Vet J. 1994; 26(3): 203–208.

McKellar QA, Delatour P, Lees P. Stereospecific pharmacodynamics and pharmacokinetics of carprofen in the dog. J Vet Pharmacol Ther. 1994; 17(6): 447–454.

Botrel MA, Haak T, Legrand C, et al. Quantitative evaluation of an experimental inflammation induced with Freund's complete adjuvant in dogs. J Pharmacol Toxicol Methods. 1994; 32(2): 63–71.