<<

[Keith W. Ward and Brian R. Smith, A Comprehensive Quantitative and Qualitative Evaluation of Extrapolation of Intravenous Pharmacokinetic Parameters from Rat, Dog, and Monkey to Humans. I. Clearance. Drug Metab Dispos 2004 32: 603-611]

APPENDIX

Compounds for which intravenous pharmacokinetic data in the rat, dog, monkey, and human were compiled for this extrapolation exercise (full list of References below).

Acivicin Dolasetron Moxestrol 1-Aminocyclopropane L-DOPA Moxifloxacin carboxylic acid Actisomide Doxorubicin Naltrexone Acyclovir Erythromycin Naproxen Alfentanil Ethosuxamide Napsagatran Amifloxacin Nicardipine Amphotericin B FCE 22101 Nicotine Antipyrine Fentanyl Nimodipine 3'-Azido-3'deoxythymidine Fleroxacin N-(phosphonacetyl)-L- aspartate Betamipron Flunisolide Pelrinone Fluvastatin Phencyclidine BRL 42715 Furosemide Caffeine Gabapentin Pirmenol Captopril GV150526 Prednisone HI-6 Propranolol Cefclidine Ifetroban Quinidine Iloprost Recainam Indomethacin Remikiren Inogatran Ro 25-6833 Iododoxorubicin SCH 34343 Ironotecan Sudoxicam Isosorbide dinitrate Susalimod Isosorbide mononitrate Tebufelone Ketorolac Tiazofurin Lamifiban Tiludronate Ciprofloxacin Lamivudine Trimethadione Citalopram Lidocaine Troglitazone Clonazepam Meperidine Trovafloxacin Cocaine Valproic acid Coumarin Methotrexate Vinblastine Cyclophosphamide Metoprolol Vincristine Diclofenac MK-571 Warfarin Didanosine Morphine Disopyramide Moxalactam

Abadía AR, Aramayona JJ, Muñoz MJ, Pla Delfina JM, Saez MP and Bregante MA (1994) Disposition of ciprofloxacin following intravenous administration in dogs. J Vet Pharmacol Ther 17:384-388. Al-Shabanah OA, El-Kashef HA, Badary OA, Al-Bekairi AM and Elmazar MMA (2000) Effect of streptozotocin-induced hyperglycaemia on intravenous and acute cardiotoxicity of doxorubicin in rats. Pharmacol Res 41:31-37. Anderson BD, Hoesterey BL, Baker DC and Galinsky RE (1990) Uptake kinetics of 2',3'- dideoxyinosine into brain and cerebrospinal fluid of rats: Intravenous infusion studies. J Pharmacol Exp Ther 253:113-118. Andrassy K, Koderisch J, Gorges K, Sonntag H and Hirauchi K (1991) Pharmacokinetics and hemostasis following administration of a new, injectable (6315-S, flomoxef) in volunteers and in patients with renal insufficiency. Infection 19:S296-302. Arnold ST, Hiremagalur NJ, Harper GR, Litterst CL, Malspeis L, DeSouza JJV, Staubus AE, Ahluwalia GS, Wilson YA, Cooney DA and Johns DG (1984) The disposition and of tiazofurin in rodents, rabbits, and dogs. Drug Metab Dispos 12:165-173. Atkison AJ Jr and Bennett JE (1978) Amphotericin B pharmacokinetics in humans. Antimicrob Agents Chemother 13:271-276. Bachmann K, Schwartz J, Sullivan T and Jauregui L (1986) Single sample estimate of ethosuximide clearance. Int J Clin Pharmacol Ther Tox 24:546-550. Baggot JD (1994) Application of interspecies scaling to the bispyridinium oxime HI-6. Am J Vet Res 55:689-691. Baldwin JR, Phillips BA, Overmeyer SK, Hatfield NZ and Narang PK (1992) Influence of the cardioprotective agent dexrazoxane on doxorubicin pharmacokinetics in the dog. Cancer Chemother Pharmacol 30:433-438. Bhargava HN and Villar VM (1992) Pharmacodynamics and pharmacokinetics of intravenously administered morphine in spontaneously hypertensive and normotensive Wistar-Kyoto rats. J Pharmacol Exp Ther 261:290-296. Benet LZ and Williams RL (1990) Design and optimization of dosage regimens: Pharmacokinetic data, in Goodman and Gilman's The Pharmacological Basis of Therapeutics (Gilman AG, Rall TW, Nies AS and Taylor P eds) pp 1650-1715, Pergamon Press, New York. Benowitz N, Forsyth RP, Melmon KL and Rowland M (1974) Lidocaine disposition kinetics in monkey and man I. Prediction by a perfusion model. Clin Pharmacol Ther 16:87-98. Bischoff KB, Dedrick RL, Zaharko DS and Longstreth JA (1971) Methotrexate pharmacokinetics. J Pharm Sci 60:1128-1133. Blaney SM, Daniel MJ, Harker AJ, Godwin K, and Bailis FM (1995) Pharmacokinetics of lamivudine and BCH-189 in plasma and cerebrospinal fluid of nonhuman primates. Antimicrob Agents Chemother 39:2779-2782. Blum MR, Liao SHT, Good SS and De Miranda P (1988) Pharmacokinetics and of zidovudine in humans. Am J Med 85(Suppl A):189-194. Bonati M, Latini R, Tognoni G, Young JF and Garattini S (1984) Interspecies comparison of in vivo caffeine pharmacokinetics in man, monkey, rabbit, rat, and mouse. Drug Metab Rev 15:1355-1383. Boni JP, Barr WH and Martin BR (1991) Cocaine inhalation in the rat: Pharmacokinetics and cardiovascular response. J Pharmacol Exp Ther 257:307-315. Boothe DM, Cullen JM, Calvin JA, Jenkins WL, Brown SA, Green RA and Corrier DE (1994) Antipyrine and caffeine dispositions in clinically normal dogs and dogs with progressive liver disease. Am J Vet Res 55:254-261.

Boxenbaum H (1982) Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokin Biopharm 10:201-226. Boxenbaum H and Ronfeld R (1983) Interspecies pharmacokinetic scaling and the Dedrick plots. Am J Physiol 245 (Regulatory Integrative Comp Physiol 14):R768-R774. Boyes RN, Adams HJ, and Duce BR (1970) Oral absorption and disposition kinetics of lidocaine hydrochloride in dogs. J Pharmacol Exp Ther 174:1-8. Chadwick M, Silveira DM, MacGregor JA, Branfman AR, Liss RH and Yesair DW (1982) Comparative physiological disposition of N-(phosphonacetyl)-L-aspartate in several animal species after intravenous and oral administration. Cancer Res 42:627-632. Chang T (1987) Preclinical and clinical pharmacokinetics of pirmenol. Am J Cardiol 59:15H- 19H. Chaplin MD, Rooks W II, Swenson EW, Cooper WC, Nerenberg C and Chu NI (1980) Flunisolide metabolism and dynamics of a metabolite. Clin Pharmacol Ther 27:402-413. Cherkofsky SC (1995) 1-Aminocyclopropanecarboxylic acid: Mouse to man interspecies pharmacokinetic comparisons and allometric relationships. J Pharm Sci 84:1231-1235. Chu NI, Amos BA, Tökés L, Maddox ML, Matin SB, Hama KM, Patterson JW, Wagner PJ, Bell JP and Chaplin MD (1979) Disposition of flunisolide in the rat, mouse, dog, rhesus monkey, and cynomolgus monkey. Drug Metab Dispos 7:81-89. Chung M, Radwanski E, Loebenberg D, Lin C-C, Oden E, Symchowicz S, Gural RP and Miller GH (1985) Interspecies pharmacokinetic scaling of Sch 34343. J Antimicrob Chemother 15:227-233. Coassolo P, Fischli W, Clozel J-P and Chou RC (1996) Pharmacokinetics of remikiren, a potent oraly active inhibitor of human renin, in rat, dog and primates. Xenobiotica 26:333-345. Colburn WA, Bekersky I, Min BH, Hodshon BJ and Garland WA (1980) Contribution of gut contents, intestinal wall and liver to the first-pass metabolism of clonazepam in the rat. Res Comm Chem Pathol Pharmacol 27:73-90. Coleman K, Griffin DRJ and Upshon PA (1991) Pharmacokinetic studies and renal dehydropeptidase stability of the new β-lactamase inhibitor BRL 42715 in animals. Antimicrob Agents Chemother 35:1748-1752. Cook CS, Rozek LF, Stolzenbach J, Anderson S, Schoenhard GL and Karim A (1993) Pharmacokinetics of a novel antiarrythmic drug, actisomide. Pharm Res 10:427-433. Covell DG, Abbrecht PH and Powers WF (1984) Changes in the pharmacology of warfarin during long-term administration in dogs. J Lab Clin Med 103:272-283. Creasey WA, Scott AI, Wei C-C, Kutcher J, Schwartz A and Marsh JC (1975) Pharmacological studies with vinblastine in the dog. Cancer Res 35:1116-1120. Cruze CA, Kelm GR and Meredith MP (1995) Interspecies scaling of tebufelone pharmacokinetic data and application to preclinical toxicology. Pharm Res 12:895-901. Danhof M, Krom DP and Breimer DD (1979) Studies on the different metabolic pathways of antipyrine in rats: Influence of phenobarbital and 3-methylcholanthrene treatment. Xenobiotica 11:695-702. Data JL, Rane A, Gerkens J, Wilkinson GR, Nies AS and Branch RA (1978) The influence of indomethacin on the pharmacokinetics, diuretic response and hemodynamics of furosemide in the dog. J Pharmacol Exp Ther 206:431-438. Davi H, Tronquet C, Caix J, Simiand J, Briot C, Berger Y and Thiercelin JF (1999) Disposition of tiludronate (Skelid) in animals. Xenobiotica 29:1017-1031. Dedrick RL, Bischoff KB and Zaharko DS (1970) Interspecies correlation of plasma concentration history of methotrexate (NSC-740). Cancer Chemother Rep 54:95-101.

De Miranda P, Krasny HC, Page DA and Elion GB (1982) Species differences in the disposition of acyclovir. Am J Med 73:31-35. Depré M, Margolskee DJ, Van Hecken A, Hsieh JSY, Buntinx A, De Schepper PJ and Rogers JD (1992) Dose-dependent kinetics of the enantiomers of MK-571, an LTD4-receptor antagonist. Eur J Clin Pharmacol 43:431-433. Dockens RC, Santone KS, Mitroka JG, Morrison RA, Jemal M, Greene DS and Barbhaiya RH (2000) Disposition of radiolabeled ifetroban in rats, dogs, monkeys, and humans. Drug Metab Dispos 28:973-980. Doyle E and Chasseaud LF (1981) Comparative pharmacokinetics of antipyrine (phenazone) in the baboon, cynomolgus monkey and rhesus monkey. Toxicology 19:159-168. Doyle E and Chasseaud LF (1981) Pharmacokinetics of isosorbide dinitrate in rhesus monkey, cynomolgus monkey, and baboon. J Pharm Sci 70:1270-1272. Doyle E, Chasseaud LF and Miller JN (1982) Comparative pharmacokinetics of frusemide in female rhesus monkeys, cynomolgus monkeys and baboons. Comp Biochem Physiol 71C:89- 93. Drusano GL, Plaisance KI, Forrest A and Standiford HC (1986) Dose ranging study and constant infusion evaluation of ciprofloxacin. Antimicrob Agents Chemother 30:440-443. Duggan DE, Hooke KF, White SD, Noll RM and Stevenson CR (1977) The effects of probenecid upon the individual components of indomethacin elimination. J Pharmacol Exp Ther 201:463-470. Duhart HM, Fogle CM, Gillam MP, Bailey JR, Slikker W JR and Paule MG (1993) Pharmacokinetics of cocaine in pregnant and nonpregnant rhesus monkeys. Repro Tox 7:429-437. Düsterberg B, Kühne G and Täuber U (1986) Half-lives in plasma and bioavailability of ethinylestradiol in laboratory animals. Arzneim-Forsch/Drug Res 36:1187-1190. Duthu GS (1985) Interspecies correlation of the pharmacokinetics of erythromycin, oleandomycin, and tylosin. J Pharm Sci 74:943-946. Edwards DMF, Marrari P, Efthymiopoulous C, Basileo G, Fraier D, Pianezzola E and Strolin- Benedetti M (1991) Pharmacokinetics of iododoxorubicin in the rat, dog, and monkey. Drug Metab Dispos 19:938-945. Efthymiopoulos C, Battaglia R and Benedetti MS (1991) Animal pharmacokinetics and interspecies scaling of FCE 22101, a . J Antimicrob Chemother 27:517-526. El Dareer SM, Struck RF, White VM, Mellett LB and Hill DL (1977) Distribution and metabolism of prednisone in mice, dogs, and monkeys. Cancer Treat Rep 61:1279-1289. El Dareer SM, White VM, Chen FP, Mellett LB and Hill DL (1977) Distribution and metabolism of vincristine in mice, rats, dogs, and monkeys. Cancer Treat Rep 61:1269-1277. El Sayed MA, Löscher W and Frey H-H (1978) Pharmacokinetics of ethosuximide in the dog. Arch Int Pharmacodyn 234:180-192. Eriksson UG, Renberg L, Bredberg U, Teger-Nilsson A-C and Regårdh CG (1998) Animal pharmacokinetics of inogatran, a low-molecular-weight thrombin inhibitor with potential use as an antithrombotic drug. Biopharm Drug Dispos 19:55-64. Eschenhof VE (1973) Studies on the disposition of the anticonvulsant clonazepam in the organisms of rat, dog, and man. Arzneim-Forsch/Drug Res 23:390-400. Evans GH, Nies AS and Shand DG (1973) The disposition of propranolol III. Decreased half-life and volume of distribution as a result of in man, monkey, dog and rat. J Pharmacol Exp Ther 186:114-122.

Forgue ST, Shyu WC, Gleason CR, Pittman KA and Barbhaiya RH (1987) Pharmacokinetics of the novel cefepime (BMY-28142) in rats and monkeys. Antimicrob Agents Chemother 31:799-804. Frey H-H and Löscher W (1980) Clinical pharmacokinetics of phenytoin in the dog: A reevaluation. Am J Vet Res 41:1635-1638. Frimodt-Møller PC, Dørflinger T and Madsen PO (1985) Amifloxacin distribution in the dog prostate. The Prostate 6:163-168. Frunicillo RJ and DiGregorio GJ (1984) Pharmacokinetics of pentobarbital, quinidine, lidocaine, and theophylline in the thermally injured rat. J Pharm Sci 73:1117-1121. Fujioka Y, Mizuno N, Morita E, Motozono H, Takahashi K, Yamanaka Y and Shinkuma D (1990) Effect of age on the gastrointestinal absorption of acyclovir in rats. J Pharm Pharmacol 43:465-469. Gardner SY and Papich MG (2001) Comparison of cefepime pharmacokinetics in neonatal foals and adult dogs. J Vet Pharmacol Ther 24:187-192. Garrelts JC and Wagner DJ (1999) The pharmacokinetics, safety, and tolerance of cefepime administered as an intravenous bolus or as a rapid infusion. Ann Pharmacother 33:1258-1261. Gasser TC, Graversen PH, Larsen EH and Dørflinger T (1987) Quinolone penetration into canine vaginal and urethral secretions. Scand J Urol Nephrol 104:101-105. Gianni L, Viganò L, Surbone A, Ballinari D, Casali P, Tarella C, Collins JM and Bonadonna G (1990) Pharmacology and clinical toxicity of 4'-iodo-4'-deoxydoxorubicin: An example of successful application of pharmacokinetics to dose escalation in Phase I trials. J Natl Cancer Inst 82:469-477. Golub MS, Eisele JH Jr and Anderson JH (1986) Maternal-fetal distribution of morphine and alfentanil in near-term sheep and rhesus monkeys. Dev Pharmacol Ther 9:12-22. Golub MS, Eisele JH Jr and Kuhnert BR (1988) Disposition of intrapartum narcotic analgesics in monkeys. Anesth Analg 67:637-643. Good SS and De Miranda P (1982) Metabolic disposition of acyclovir in the guinea pig, rabbit, and monkey. Am J Med 73:91-95. Grant SM and Goa KL (1992) Iloprost: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in peripheral vascular disease, myocardial ischaemia and extracorporeal circulation procedures. Drugs 43:889-924. Greene RF, Miser AW, Lester CM, Bailis FM and Poplack DG (1987) Cerebrospinal fluid and plasma pharmacokinetics of morphine infusions in pediatric cancer patients and rhesus monkeys. Pain 30:339-348. Grygiel JJ, Bailis FM, Collins JM, Lester CM and Poplack DG (1985) Pharmacokinetics of tiazofurin in the plasma and cerebrospinal fluid of rhesus monkeys. Cancer Res 45:2037- 2039. Guissou P, Cuisinaud G, Legheand J and Sassard J (1987) Chronopharmacokinetics of indometacin in rats. Arzneim-Forsch/Drug Res 37:1034-1037. Hammerstad JP, Woodward WR, Gliessman P, Boucher B and Nutt JG (1990) L-dopa pharmacokinetics in plasma and cisternal and lumbar cerebrospinal fluid of monkeys. Ann Neurol 27:495-499. Harrison MP, Moss SR, Featherstone A, Fowkes AG, Sanders AM and Case DE (1989) The disposition and metabolism of meropenem in laboratory animals and man. J Antimicrob Chemother 24:265-277. Haskins NJ, Waddell KA, Ford GC, Spalton PN, Walls CM, Forrest TJ and Palmer RF (1980) The absorption of disopyramide in animals determined using a stable isotope co- administration technique. Biomed Mass Spect 7:80-84.

Higuchi S and Shiobara Y (1980) Comparative pharmacokinetics of nicardipine hydrochloride, a new vasodilator, in various species. Xenobiotica 10:447-454. Hildebrand M (1994) Inter-species extrapolation of pharmacokinetic data of three prostacyclin- mimetics. Prostaglandins 48:297-312. Huang M-L and Jusko WJ (1990) Nonlinear pharmacokinetics and interconversion of predisolone and prednisone in rats. J Pharmacokin Biopharm 18:401-421 Hug CC Jr and Murphy MR (1981) Tissue redistribution of fentanyl and termination of its effects in rats. Anesthesiology 55:369-375. Hümpel M, Nieuweboer B, Wendt H and Speck U (1979) Investigations of pharmacokinetics of ethinyloestradiol to specific consideration of a possible first-pass effect in women. Contraception 19:421-432. Hussey EK, Donn KH, Daniel MJ, Hall ST, Harker AJ and Evans GL (1994) Interspecies scaling and pharmacokinetic parameters of 3TC in humans. J Clin Pharmacol 34:975-977. Iavarone L, Hoke JF, Bottacini M, Barnaby R and Preston GC (1999) First time in human for GV196771: Interspecies scaling applied on dose selection. J Clin Pharmacol 39:560-566. Ilkiw JE and Benthuysen JA (1991) Comparative study of the pharmacokinetics of alfentanil in rabbits, sheep, and dogs. Am J Vet Res 52:581-584. Inaba M, Ohnishi Y, Ishii H, Tanioka Y, Yoshida Y, Sudoh K, Hakusui H, Mizuno N, Ito K and Sugiyama Y (1998) Pharmacokinetics of CPT-11 in rhesus monkeys. Cancer Chemother Pharmacol 41:103-108. Izumi T, Enomoto S, Hosiyama K, Sasahara K, Shibukawa A, Nakagawa T and Sugiyama Y (1996) Prediction of the human pharmacokinetics of troglitazone, a new and extensively metabolized antidiabetic agent, after oral administration, with an animal scale-up approach. J Pharmacol Exp Ther 27:1630-1641. Jacob P III, Benowitz NL, Copeland JR, Risner ME and Cone EJ (1988) Disposition kinetics of nicotine and cotinine enantiomers in rabbits and Beagle dogs. J Pharm Sci 77:396-400. Jagdis FA, Hoeprich PD, Lawrence RM and Schaffner CP (1977) Comparative pharmacology of amphotericin B and amphotericin B methyl ester in the non-human primate Macaca mulatta. Antimicrob Agents Chemother 12:582-590. Jannuzzo MG, Mandelli M, Benedetti MS, Moro E, Carnovali M, Vaini R and Sassella D (1989) Pharmacokinetics and tolerance of a new penem antibiotic, FCE 22101, in healthy volunteers after a single intravenous dose. Eur J Clin Pharmacol 36:633-635. Johnson JA and Benziger DP (1985) Metabolism and disposition of amifloxacin in laboratory animals. Antimicrob Agents Chemother 27:774-781. Jung D, Mroszczak E and Bynum L (1988) Pharmacokinetics of ketorolac tromethamine in humans after intravenous, intramuscular and oral administration. Eur J Clin Pharmacol 35:423-425. Karim A, Kook C, Campion J and Doherty M (1977) Disopyramide phosphate: Tissue uptake and relationship between drug concentrations in the plasma and myocardium in rats. Arch Int Pharmacodyn 228:222-236. Karim A, Kook C, Novotney RL, Zageralla J and Campion J (1978) Pharmacokinetics and steady-state myocardial uptake of disopyramide in the dog. Drug Metab Dispos 6:338-345. Karim A, Nissen C and Azarnoff DL (1982) Clinical pharmacokinetics of disopyramide. J Pharmacokin Biopharm 10:465-494. Kaul S, Knupp CA, Dandekar KA, Pittman KA and Barbhaiya RH (1991) Pharmacokinetics of 2',3'-dideoxyinosine (BMY-40900), a new anti-human immunodeficiency virus agent, after administration of single intravenous doses to beagle dogs. Antimicrob Agents Chemother 35:610-614.

Kim H, Loebenberg D, Marco A, Symchowicz S and Lin C (1984) Comparative pharmacokinetics of Sch 28191 and amphotericin B in mice, rats, dogs, and cynomolgus monkeys. Antimicrob Agents Chemother 26:446-449. Kimura Y, Nakashimizu H, Nakano M, Otsubo R, Matsubara H and Yoshida T (1987) Pharmacokinetic characterization of 6315-S (Flomoxef) in experimental animals. Chemotherapy (Tokyo) 35(S-1):161-175. Kita Y, Kimura Y, Yamazaki T and Imada A (1993) Cefozopran, a new antibiotic: Pharmacokinetics in experimental animals. Chemotherapy (Tokyo) 41(S-4):121-130. Kleinbloesem CH, Weber C, Fahrner E, Dellenback M, Welker H, Schröter V and Belz GG (1993) Hemodynamics, biochemical effects, and pharmacokinetics of the renin inhibitor remikiren in health human subjects. Clin Pharmacol Ther 53:585-592. Klotz U, McHorse TS, Wilkinson GF and Schenker S (1974) The effect of cirrhosis on the disposition and elimination of meperidine in man. Clin Pharmacol Ther 16:667-675. Knodell RG, Allen RC and Kyner WT (1982) Effects of ethinyl on pharmacokinetics of meperidine and pentobarbital in the rat. J Pharmacol Exp Ther 221:1-6. Koch KM, Ludwick BT and Levy RH (1981) Phenytoin-valproic acid interaction in rhesus monkey. Epilepsia 22:19-25. Koup JR, Olson SC and Ridout G (1997) Bayesian estimation of troglitazone pharmacokinetic parameters following intravenous and oral administration. Pharm Res 14:S243. Krause W, Schubert M, and Totzek M (1983) Pharmacokinetics and biotransformation of the prostacyclin analogue, ZK 36 374, in the monkey (Macaca fascicularis). Prostaglandins Leukotrienes Med 11:325-338. Kripalani KJ, Singhvi SM, Weinstein SH, Everett DW, Bathala MS, Dean AV, Ita CE, Lawrence L, Meeker FS Jr, Shaw JM, Walker BD and Midgalof BH (1984) Disposition of [14C]aztreonam in rats, dogs, and monkeys. Antimicrob Agents Chemother 26:119-126. Kurihara A, Naganuma H, Hisaoka M, Tokiwa H and Kawahara Y (1992) Prediction of human pharmacokinetics of panipenim-betamipron, a new , from animal data. Antimicrob Agents Chemother 36:1810-1816. Kusajima H, Ishikawa N, Machida M, Uchida H and Irikura T (1986) Pharmacokinetics of a new quinolone, AM-833, in mice, rats, rabbits, dogs, and monkeys. Antimicrob Agents Chemother 30:304-309. Kyerematen GA, Taylor LH, DeBethizy JD and Vessell ES (1988) Pharmacokinetics of nicotine and 12 metabolites in the rat: Application of a new radiometric high performance liquid chromatography assay. Drug Metab Dispos 16:125-129. Lai AA and Levy RH (1978) Pharmacokinetic profile of clonazepam in rhesus monkeys. J Pharm Sci 67:295-299 Lai AA, Levy RH and Martis L (1980) Pharmacokinetic profile of valproic acid in rhesus monkeys following single bolus and constant rate intravenous administrations. Thérapie 35:221-232. Langley MS and Sorkin EM (1989) Nimodipine: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in cerebrovascular disease. Drugs 37:669-699. Lave T, Saner A, Coassolo P, Brandt R, Schmitt-Hoffmann AH and Chou RC (1996) Animal pharmacokinetics and interspecies scaling from animals to man of lamifiban, a new platelet aggretation inhibitor. J Pharm Pharmacol 48:573-577. Lavé T, Portmann R, Schenker G, Gianni A, Guenzi A, Girometta M-A and Schmitt M (1999) Interspecies pharmacokinetic comparisons and allometric scaling of napsagatran, a low molecular weight thrombin inhibitor. J Pharm Pharmacol 51:85-91.

Lode H (1989) Pharmacokinetics and clinical results of parenterally administered new quinolones in humans. Rev Infectious Dis 2 (Suppl 5):S996-S1004. Löscher W (1978) Serum protein binding and pharmacokinetics of valproate in man, dog, rat and mouse. J Pharmacol Exp Ther 204:255-261. Mandema JW and Wada DR (1995) Pharmacodynamic model for acute tolerance development to the electroencephalographic effects of alfentanil in the rat. J Pharmacol Exp. Ther 275:1185- 1194. Maruhn D, Siefert HM, Weber H, Rämsch K and Suwelack D (1985) Pharmacokinetics of nimodipine I. Communication: Absorption, concentration in plasma and excretion after single administration of [14C]nimodipine in rat, dog, and monkey. Arzneim-Forsch/Drug Res 35:1781-1786. Matsui H, Komiya M, Ikeda C and Tachibana A (1984) Comparative pharmacokinetics of YM- 13115, ceftriaxone, and in rats, dogs, and rhesus monkeys. Antimicrob Agents Chemother 26:204-207. Matsushita H, Suzuki H, Sugiyama Y, SawadaY, Iga T, Hanano M and Kawaguchi Y (1990) Prediction of the pharmacokinetics of cefodizime and cefotetan in humans from pharmacokinetic parameters in animals. J Pharmacobio-Dyn 13:602-611. McLean MJ (1994) Clinical pharmacokinetics of gabapentin. Neurology 44:S17-S22. McCoy LF, Crawmer BP and Benziger DP (1985) Analysis of amifloxacin in plasma and urine by high-pressure liquid chromatography and intravenous pharmacokinetics in rhesus monkeys. Antimicrob Agents Chemother 27:769-773. McGovren JP, Williams MG and Stewart JC (1988) Interspecies comparison of acivicin pharmacokinetics. Drug Metab Dispos 16:18-22. Melink TJ, Von Hoff DD, Kunh JG, Hersh MR, Sternson LA, Patton TF, Siegler R, Boldt DH and Clark GM (1985) Phase I evaluation and pharmacokinetics of tiazofurin (2-β-D- ribofuranosylthiazole-4-carboxamide, NSC 286193). Cancer Res 45:2859-2865. Mellett LB (1969) Comparative . Prog Drug Res 13:136-169. Milne RW, Nation RL and Somogyi AA (1996) The disposition of morphine and its 3- and 6- glucuronide metabolites in humans and animals, and the importance of the metabolites to the pharamcological effects of morphine. Drug Metab Rev 28:345-472. Miyamoto Y, Ozaki M and Yamamoto H (1988) Effects of adrenalectomy on pharmacokinetics and antinociceptive activity of morphine in rats. Japan J Pharmacol 46:379-386. Moriyama M, Watanabe N, Toyosawa T, Sugihara Y, Katsu K and Kitoh K (1992) Pharmacokinetic characterization of in experimental animals. Chemotherapy (Tokyo) 40(S-4):215-222. Morrison RA and Fung H-L (1984) Isosorbide dinitrate disposition in the rat: Metabolite pharmacokinetics and interactions. J Pharmacol Exp Ther 231:124-130. Mroszczak EJ, Lee FW, Combs D, Sarnquist FH, Huang B-L, Wu AT, Tokes LG, Maddox ML and Cho DK (1987) Ketorolac tromethamine absorption, distribution, metabolism, excretion, and pharmacokinetics in animals and humans. Drug Metab Dispos 15:618-626. Murakawa T, Sakamoto H, Fukada S, Nakamoto S, Hirose T, Itoh N and Nishida M (1980) Pharmacokinetics of ceftizoxime in animals after parenteral dosing. Antimicrob Agents Chemother 17:157-164. Murphy MR, Hug CC Jr and McClain DA (1983) Dose-independent pharmacokinetics of fentanyl. Anesthesiology 59:537-540. Murthy SS, Nelson WL, Shen DD, Power JM, Cahill CM and McLean AJ (1991) Pharmacokinetic interaction between verapamil and metoprolol in the dog: Stereochemical aspects. Drug Metab Dispos 19:1093-1100.

Nagashima R and Levy G (1969) Comparative pharmacokinetics of coumarin anticoagulents V. Kinetics of warfarin elimination in the rat, dog, and rhesus monkey compared to man. J Pharm Sci 58:845-849. Nakashima M and Nishijima K (1984) Clinical phase I study of ceftriaxone (Ro 13-9904). Chemotherapy (Tokyo) 32(S-7):178-196. Nelson RL, Dyke RW and Root MA (1980) Comparative pharmacokinetics of vindesine, vincristine and vinblastine in patients with cancer. Cancer Treat Rev 7:17-24. Ochs HR, Greenblatt DJ, Woo E, Franke K and Smith TW (1978) Effect of propranolol on pharmacokinetics and acute electrocardiographic changes following intravenous quinidine in humans. Pharmacology 17:301-306. Ogiso T, Ito Y, Iwaki M and Atago H (1989) A pharmacokinetic model for the percutaneous absorption of indomethacin and the prediction of drug disposition kinetics. J Pharm Sci 78:319-323. Olsen KM, Rebuck JA, Weidenback T and Fish DN (2000) Pharmacokinetics of intravenous trovafloxacin in critically ill adults. Pharmacotherapy 20:400-404. Overo KF (1982) Kinetics of citalopram in test animals: Drug exposure in safety studies. Prog Neuro-Psychopharmacol & Biol Psychiat 6:297-309. Owens SM, Hardwick WC and Blackall D (1987) Phencyclidine pharmacokinetic scaling among species. J Pharmacol Exp Ther 242:96-101. Pace NL, Parrish RG, Lieberman MM, Wong KC and Blatnick RA (1979) Pharmacokinetics of naloxone and naltrexone in the dog. J Pharmacol Exp Ther 208:254-256. Påhlman I, Edholm M, Kankaanranta S and Odell M-L (1998) Pharmacokinetics of susalimod, a highly biliary-excreted sulphasalazine analogue, in various species. Nonpredictable human clearance by allometric scaling. Pharm Pharmacol Comm 4:493-498. Parker RB, Laizure SC, Williams CL, Mandrell TD and Lima JJ (1998) Evaluation of dose- dependent pharmacokinetics of cocaethylene and cocaine in conscious dogs. Life Sci 62:333-342. Pasloske K, Renaud R, Burger J and Conlon P (1999) Pharmacokinetics of ketorolac after intravenous and oral single dose administration in dogs. J Vet Pharmacol Ther 22:314-319. Patel BA, Chu CK and Boudinot FD (1989) Pharmacokinetics and saturable renal tubular secretion of zidovudine in rats. J Pharm Sci 78:530-534. Patel BA, Boudinot FD, Schinazi RF, Gallo JM and Chu CK (1990) Comparative pharmacokinetics and interspecies scaling of 3'-azido-3'deoxythymidine (AZT) in several mammalian species. J Pharmacobio-Dyn 13:206-211. Patel IH, Levy RH and Bauer TG (1975) Pharmacokinetic properties of ethosuxamide in monkeys. I. Single-dose intravenous and oral administration. Epilepsia 16:705-716. Perucca E, Gatti G, Frigo GM and Crema A (1978) Pharmacokinetics of valproic acid after oral and intravenous administration. Br J Clin Pharmacol 5:313-318. Peterson LR, Gerding DN, Van Etta LL, Eckfeldt JH and Larson TA (1982) Pharmacokinetics, protein binding, and extravascular distribution of ceftizoxime in normal subjects. Antimicrob Agents Chemother 22:878-881. Prebmar F, Niedlein R, Strein K and Bartsch W (1992) Pharmacokinetics of the organic nitrates trans-2-amino-2-methyl-N-(4-nitroxycyclohexylmethyl)-propionamide in dogs, and of 4-(2- nitroxyethyl)-piperadine in dogs and in monkeys. Arzneim-Forsch/Drug Res 42:1186-1191. Qian M, Finco TS, Swagler AR and Gallo JM (1991) Pharmacokinetics of 2',3'-dideoxyinosine in monkeys. Antimicrob Agents Chemother 35:1247-1249.

Qian M and Gallo JM (1992) High-performance liquid chromatographic determination of the calcium channel blocker nimodipine in monkey plasma. J Chromatogr Biomed Appl 578:316-320. Radulovic LL, Türck D, von Hodenberg A, Vollmer KO, McNally WP, DeHart PD, Hanson BJ, Bockbrader HN and Chang T (1995) Disposition of gabapentin (Neurontin) in mice, rats, dogs, and monkeys. Drug Metab Dispos 23:441-448. Rakhit A, Guentert TW, Holford NHG, Verhoeven J and Riegelman S (1984) Pharmacokinetics and pharmacodynamics of quinidine and its metabolite, quinidine-N-oxide, in beagle dogs. Eur J Drug Metab Pharmacokin 9:315-324. Rane A, Högstedt S, Lindberg B, Regårdh CG and Jorluf H (1984) Comparison of different clearance estimates for metoprolol in the rhesus monkey. J Pharmacol Exp Ther 228:774- 778. Reuning RH, Ashcraft SB, Wiley JN and Morrison BE (1989) Disposition and pharmacokinetics of naltrexone after intravenous and oral administration in rhesus monkeys. Drug Metab Dispos 17:583-589. Richter WF, Heizmann P, Meyer J, Starke V and Lave T (1998) Animal pharmacokinetics and interspecies scaling of Ro 25-6833 and related (lactamylvinyl). J Pharm Sci 87:496-500. Riess W, Stierlin H, Degen P, Faigle JW, Gérardin, Moppert J, Sallman A, Schmid K, Schweizer A, Sule M, Theobald W and Wagner J (1978) Pharmacokinetics and metabolism of the anti- inflammatory agent Voltaren. Scand J Rheumatology 22:17-29. Ritschel WA, Neub M and Denson DD (1987) Meperidine pharmacokinetics following intravenous, peroral and buccal administration in Beagle dogs. Meth Find Exp Clin Pharmacol 9:811-815. Ritschel WA, Vachharajani NN, Johnson RD and Hussain AS (1991) Interspecies scaling of the pharmacokinetic parameters of coumarin among six different mammalian species. Meth Find Exp Clin Pharmacol 13:697-702. Robbie G and Chiou WL (1998) Elucidation of human amphotericin B pharmacokinetics: Identification of a new potential factor affecting interspecies pharmacokinetic scaling. Pharm Res 15:1630-1636. Robertson DRC, Wood ND, Everest H, Monks K, Waller DG, Renwick AG and George CF (1989) The effect of age on the pharmacokinetics of levodopa administered alone and in the presence of carbidopa. Br J Clin Pharmacol 28:61-69. Rose S, Jenner P and Marsden CD (1991) Peripheral pharmacokinetic handling and metabolism of L-dopa in the rat: The effect of route of administration and carbidopa treatment. J Pharm Pharmacol 43:325-330. Rowland M, Thomson PD, Guichard A and Melmon KL (1971) Disposition kinetics of lidocaine in normal subjects. Ann NY Acad Sci 179:383-398. Runkel R, Chaplin M, Boost G, Segre E and Forchielli E (1972) Absorption, distribution, metabolism, and excretion of naproxen in various laboratory animals and human subjects. J Pharm Sci 61:703-708. Saito A, Miura T and Tarao F (1994) Pharmacokinetic study on biapenem. Chemotherapy (Tokyo) 42(S-4):277-284. Salmon J, Coussediere, Cousty C and Raunaud JP (1983) Pharmacokinetics and metabolism of moxestrol in animals – rat, dog and monkey. J Biochem 19:1223-1234. Sansom LN, Necciari J and Thiercelin JF (1995) Human pharmacokinetics of tiludronate. Bone 17:479S-483S.

Sanwald-Ducray P and Dow J (1997) Prediction of the pharmacokinetic parameters of reduced- dolasetron in man using in vitro-in vivo and interspecies allometric scaling. Xenobiotica 27:189-201. Sasahara K, Nitanai T, Habara T, KojimaT, Kawahara Y, Morioka T and Nakajima E (1981) Dosage form design for improvement of bioavailability of levodopa IV: Possible causes of low bioavailability of oral levodopa in dogs. J Pharm Sci 70:730-733. Sawada Y, Hanano M, Sugiyama Y and Iga T (1984) Prediction of the disposition of β-lactam in humans from pharmacokinetic parameters in animals. J Pharmacokin Biopharm 12:241-260. Sawada Y, Hanano M, Sugiyama Y and Iga T (1985) Prediction of the disposition of nine weakly acidic and six weakly basic drugs in humans from pharmacokinetic data in rats. J Pharmacokin Biopharm 13:477-492. Scatina JA, Hicks DR, Kraml M and Cayen MN (1990) Metabolic disposition and pharmacokinetics of pelrinone, a new cardiotonic drug, in laboratory animals and man. Eur J Drug Metab Pharmacokin 15:37-48. Scatina JA, Kimmel HB, Weinstein V, Troy SM, Sisenwine SF and Cayen MN (1990) Species differences in the pharmacokinetics of recainam, a new anti-arrythmic drug. Biopharm Drug Dispos 11:445-461. Scripture CD and Pieper JA (2001) Clinical pharmacokinetics of fluvastatin. Clin Pharmacol Ther 40:263-281. Sethi VS, Surratt P and Spurr CL (1984) Pharmacokinetics of vincristine, vinblastine, and vindesine in rhesus monkeys. Cancer Chemother Pharmacol 12:31-35. Siefert HM, Maruhn D, Maul W, Förster D and Ritter W (1986) Pharmacokinetics of ciprofloxacin. 1st communication: Absorption, concentrations in plasma, metabolism and excretion after a single administration of [14C]ciprofloxacin in abino rats and rhesus monkeys. Arzneim-Forsch/Drug Res 36:1496-1502. Siefert HM, Domdey-Bette A, Henninger K, Hucke F, Kohlsdorfer C and Stass HH (1999) Pharmacokinetics of the 8-methoxyquinolone, moxifloxacin: A comparison in humans and other mammalian species. J Antimicrob Chemother 43:69-76. Singhvi SM, Peterson AE, Ross JJ Jr, Shaw JM, Keim GR and Migdalof BH (1981) Pharmacokinetics of captopril in dogs and monkeys. J Pharm Sci 70:1108-1112. Sisenwine SF and Reulius HW (1971) Plasma concentrations and urinary excretion of isosorbide dinitrate and its metabolites in the dog. J Pharmacol Exp Ther 176:296-301. Sponer G, Kühnle H-F, Strein K, Bartsch W, Endele R and Dietmann K (1984) Pharmacokinetic aspects of isosorbide-5-mononitrate in dogs. J Pharmacol Exp Ther 228:235-239. Swabb EA and Bonner DP (1983) Prediction of aztreonam pharmacokinetics in humans based on data from animals. J Pharmacokin Biopharm 11:215-223. Takenaka T, Watanabe T, Hayashi T, Hata K, Ono N, Kumon H and Ohmori H (1993) Pharmacokinetics and dosage planning of cefozopran in patients with renal insufficiency. Chemotherapy (Tokyo) 41(S-4):147-153. Tanaka E, Ishikawa A and Horie T (1999) In vivo and in vitro trimethadione oxidation activity of the liver from various animal species including mouse, hamster, rat, rabbit, dog, monkey and human. Hum Exp Toxicol 18:12-16. Tang W, Stearns RA, Kwei GY, Iliff SA, Miller RR, Egan MA, Yu NX, Dean DC, Kumar S, Shou M, Lin JH and Baillie TA (1999) Interaction of diclofenac and quinidine in monkeys: Stimulation of diclofenac metabolism. J Pharmacol Exp Ther 291:1068-1074.

Taylor T, Casseaud LF, Doyle E, Darragh A, O'Kelly DA and Fitzgerald (1980) Pharmacokinetics of isosorbide dinitrate after intravenous infusion in human subjects. Biopharm Drug Dispos 1:149-156. Taylor T, Chasseaud LF, Major R and Doyle E (1981) Isosorbide 5-mononitrate pharmacokinetics in humans. Biopharm Drug Dispos 2:255-263. Teger-Nilsson A-C, Eriksson U, Gustafsson D, Bylund R, Fager G and Held P (1995) Phase I studies on inogatran, a new selective thrombin inhibitor. J Am Coll Cardiol 25:117A-118A. Teng R, Girard D, Gootz TD, Foulds G and Liston TE (1996) Pharmacokinetics of trovafloxacin (CP-99,219), a new quinolone, in rats, dogs, and monkeys. Antimicrob Agents Chemother 40:561-566. Tocco DJ, DeLuna FA, Duncan EW, Hsieh JH and Lin JH (1990) Interspecies differences in stereoselective protein binding and clearance of MK-571. Drug Metab Dispos 18:388-392. Tse FLS, Smith HT, Ballard FH and Nicoletti J (1990) Disposition of fluvastatin, an inhibitor of HMG-CoA reductase, in mouse, rat, dog, and monkey. Biopharm Drug Dispos 11:519-531. Tsuchiya T, Terakawa M, Ishibashi K, Noguchi H and Kato R (1980) Disposition and enterohepatic recirculation of diclofenac in dogs. Arzneim-Forsch/Drug Res 30:1650-1653. Turner DM (1975) Influence of route of administration on metabolism of [14C]nicotine in four species. Xenobiotica 5:553-561. Tzeng T-B and Fung H-L (1992) Pharmacokinetic/pharmacodynamic relationship of the duration of vasodilating action of organic mononitrates in rats. J Pharmacol Exp Ther 261:692-700. Ueda CT, Ballard BE and Rowland M (1977) Concentration-time effects on quinidine disposition kinetics in rhesus monkeys. J Pharmacol Exp Ther 200:459-468. Valverde CR, Mama KR, Kollias-Baker C, Steffey EP and Baggot JD (2000) Pharmacokinetics and cardiopulmonary effects of fentanyl in isofluorane-anesthetized rhesus monkeys (Macaca mulatta). Am J Vet Res 61:931-934. Vermeulen AM, Belpaire FM, De Smet F, Vercruysse I and Bogaert MG (1993) Aging and the pharmacokinetics and metabolism of metoprolol enantiomers in the rat. J Gerontology Biol Sci 48:B108-B-114. Vollmer KO, von Hodenberg A and Kölle EU (1986) Pharmacokinetics and metabolism of gabapentin in rat, dog and man. Arzneim-Forsch/Drug Res 36:830-839. Vollmer KO, Türck D, Bockbrader HN, Busch JA, Chang T, Welling PG, Reece PA, Underwood B and Sedman AJ (1992) Summary of Neurontin (gabapentin) clinical pharmacokinetics. Epilepsia 33:77. Wallin JD, Ryals P and Kaplowitz N (1976) Metabolic clearance of furosemide in the rat. J Pharmcol Exp Ther 200:52-57. Warren KE, McCully CM, Walsh TJ and Bailis FM (2000) Effect of fluconazole on the pharmacokinetics of doxorubicin in nonhuman primates. Antimicrob Agents Chemother 44:1100-1101. Weidekamm E, Portmann R, Suter K, Partos C, Dell D and Lücker PW (1987) Single- and multiple-dose pharmacokinetics of fleroxacin, a trifluorinated quinolone, in humans. Antimicrob Agents Chemother 31:1909-1914. Wiseman EH and Chiaini J (1972) Anti-inflammatory and pharmacokinetic properties of sudoxicam N-(2-thiazolyl)-4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide 1,2- dioxide. Biochem Pharmacol 21:2323-2334. Yamasaku F, Suzuki Y and Uno K (1992) Pharmacokinetic studies on cefclidin, ceftazidine and cefpiramide. Chemotherapy (Tokyo) 40(S-4):240-244.

Yacobi A and Levy G (1975) Comparative pharmacokinetics of coumarin anticoagulents XIV. Relationship between protein binding, distribution, and elimination kinetics of warfarin in rats. J Pharm Sci 64:1660-1664. Yamashita N, Kawashima K, Nomura K, Takeuchi H, Hikida M and Naruke T (1994) Pharmacokinetics of biapenem in laboratory animals. Chemotherapy (Tokyo) 42(S-4):243- 250. Yeung JHK, Breckenridge AM and Park BK (1983) Drug-protein conjugates – IV. The effect of acute renal failure on the disposition of [14C]captopril in the rat. Biochem Pharmacol 32:2467-2472. Zhou XJ, Martin M, Placidi M, Cano JP and Rahmani R (1990) In vivo and in vitro pharmacokinetics and metabolism of vincaalkaloids in rat II. Vinblastine and vincristine. Eur J Drug Metab Pharmacokin 15:323:332.