Clinical pharmacokinetics: current requirements and future perspectives from a regulatory point of view

References

• Alvan G. Clinical consequences of polymorphic drug oxidation. Fundamental and Clinical Pharmacology 1991; 5: 209–228
   PubMed Web of Science ®Google Scholar
• Al-Dabbagh S. G., Idle J. R., Smith R. L. Animal modelling of human polymorphic drug oxidation—the metabolism of debrisoquine and phenacetin in rat inbred strains. Journal of Pharmacy and Pharmacology 1981; 33: 161–164
   PubMed Web of Science ®Google Scholar
• Anon., Cardiotoxic effects of pimozide. Current Problems No. 29. Committee on Safety of Medicines, London August, 1990
   Google Scholar
• Anon., Terodiline withdrawn worldwide. Scrip 20 September, 1991a; 1653: 19
   Google Scholar
• Anon., Terodiline withdrawn in Japan. Scrip 2 October, 1991b; 1656: 25
   Google Scholar
• Anon., Withdrawal of terodiline (Micturin, Kabi Pharmacia Ltd). Current Problems No. 32. Committee on Safety of Medicines, London October, 1991c
   Google Scholar
• Anon., Ventricular arrhythmias due to terfenadine and astemizole. Current Problems No. 35. Committee on Safety of Medicines, London November, 1992
   Google Scholar
• Anon., Increased mortality with Manoplax. Scrip 30 April, 1993a; 1816: 24
   Google Scholar
• Anon., Manoplax mortality concerns addressed. Scrip 4 May, 1993b; 1817: 27
   Google Scholar
• Anon., Ketorolac: new restrictions on dose and duration of treatment. Current Problems 1993c; 19: 5–6
   Google Scholar
• Ariens E. J. Stereochemistry, a basis for sophisticated non-sense in pharmacokinetics and clinical pharmacology. European Journal of Clinical Pharmacology 1984; 26: 663–668
   PubMed Web of Science ®Google Scholar
• Balant L. P., Gundert-Remy U., Boobis A. R., Von Bahr C. H. Relevance of genetic polymorphism in drug metabolism in the development of new drugs. European Journal of Clinical Pharmacology 1989; 36: 551–554
   PubMed Web of Science ®Google Scholar
• Barnett D. B. Flosequinan. Lancet 1993; 341: 733–736
   PubMed Web of Science ®Google Scholar
• Beckmann J., Hertrampf R., Gundert-Remy U., Mikus G., Gross A. S., Eichelbaum M. Is there a genetic factor in flecainide toxicity?. British Medical Journal 1988; 297: 1316
   PubMed Web of Science ®Google Scholar
• Bergstrand R. H., Wang T., Roden D. M., Avant G. R., Sutton W. W., Siddoway L. A., Wolfenden H., Woosley R. L., Wilkinson G. R., Wood A. J. J. Encainide disposition in patients with chronic cirrhosis. Clinical Pharmacology and Therapeutics 1986; 40: 148–154
   PubMed Web of Science ®Google Scholar
• Bertilsson L., Aberg-Wistedt A., Gustafsson L. L., Nordin C. Extremely rapid hydroxylation of debrisoquine: a case report with implication for treatment with nortriptyline and other tricyclic antidepressants. Therapeutic Drug Monitoring 1985; 7: 478–480
   PubMed Web of Science ®Google Scholar
• Bertilsson L., Dahl M.-L., Sjoqvist F., Wistedt A.-A., Humble M., Johansson I., Lundqvist E., Ingelman-Sundberg M. Molecular basis for rational megaprescribing in ultrarapid hydroxylators of debrisoquine. Lancet 1993; 341: 63
   PubMed Web of Science ®Google Scholar
• Bertilsson L., Mellstrom B., Sjoqvist F., Martensson B., Asberg M. Slow hydroxylation of nortriptyline and concomitant poor debrisoquine hydroxylation: clinical implications. Lancet 1981; i: 560–561
   Google Scholar
• Bluhm R. E., Wilkinson G. R., Shelton R., Branch R. A. Genetically determined drug-metabolizing activity and desipramine-associated cardiotoxicity: a case report. Clinical Pharmacology and Therapeutics 1993; 53: 89–95
   PubMed Web of Science ®Google Scholar
• Boobis A. R. Enzymatic studies in genetic polymorphisms of drug metabolism. European Concensus Conference on Pharmacogenetics, G. Alvan, L. P. Balant, P. R. Bechtel, A. R. Boobis, L. F. Gram, K. Pithan. Commission of the European Communities, Office for Official Publications of the European Communities, Luxembourg 1990; 15–26
   Google Scholar
• Branch R. A., Neis A. S., Shand D. G. Disposition of propranolol. Part 8. General implication of the effects of liver blood flow on elimination from the perfused rat liver. Drug Metabolism and Disposition 1973; 1: 687–690
   PubMed Web of Science ®Google Scholar
• Braun J., Kollert J. R., Becker J. U. Pharmacokinetics of flecainide in patients with mild and moderate renal failure compared with patients with normal renal function. European Journal of Clinical Pharmacology 1987; 31: 711–714
   PubMed Web of Science ®Google Scholar
• Brosen K., Hansen J. G., Nielsen K. K., Sindrup S. H., Gram L. F. Inhibition by paroxetine of desipramine metabolism in extensive but not in poor metabolizers of sparteine. European Journal of Clinical Pharmacology 1993; 44: 349–355
   PubMed Web of Science ®Google Scholar
• Chandler M. H. H., Scott S. R., Blouin R. A. Age-associated stereoselective alterations in hexobarbital metabolism. Clinical Pharmacology and Therapeutics 1988; 43: 436–441
   PubMed Web of Science ®Google Scholar
• Cho A. K., Wright J. Pathways of metabolism of amphetamine and related compounds. Life Sciences 1978; 22: 363–372
   PubMed Web of Science ®Google Scholar
• Cholerton S., Daly A. K., Idle J. R. The role of individual human cytochromes P-450 in drug metabolism and clinical response. Trends in Pharmacological Sciences 1992; 13: 434–439
   PubMed Web of Science ®Google Scholar
• Cooper R. G., Evans D. A. P., Whibley E. J. Polymorphic hydroxylation of perhexiline maleate in man. Journal of Medical Genetics 1984; 21: 27–33
   PubMed Web of Science ®Google Scholar
• Cowley A. J., Wynne R. D., Stainer K., Fullwood L., Rowley J. M., Hampton J. R. Flosequinan in heart failure: acute haemodynamic and longer term symptomatic effects. British Medical Journal 1988; 297: 169–173
   PubMedGoogle Scholar
• De Cree J., Geukens H., Verhaegen H. Comparative haemodynamics of dextro- and levo-isomers and the racemic mixture of DL-nebivolol. European Heart Journal 1990; 11: 332, Suppl.
   Google Scholar
• Ebelin M. E., Steimer J. L., Laplanche R., Niederbergen W. An Evaluation of Population Pharmacokinetics During Drug Development and Clinical Evaluation: The Population Approach, M. Rowland, L. Aarons. Commission of European Communities, Office for Official Publications of the European Communities, Luxembourg 1992; 131–142
   Google Scholar
• Eichelbaum M., Gross A. S. The genetic polymorphism of debrisoquine/sparteine metabolism—clinical aspects. Pharmacogenetics of Drug Metabolism, W. Kalow. Pergamon, New York 1992a; 625–648
   Google Scholar
• Eichelbaum M., Kroemer H. K., Mikus G. Genetically determined differences in drug metabolism as a risk factor in drug toxicity. Toxicology Letters 1992b; 64: 115–122
   PubMed Web of Science ®Google Scholar
• Eichelbaum M., Mineshita S., Ohnhaus E. E., Zekorn C. The influence of enzyme induction on polymorphic sparteine oxidation. British Journal of Clinical Pharmacology 1986; 22: 49–53
   PubMed Web of Science ®Google Scholar
• Evans D. A. P. N-acetyltransferase. Pharmacogenetics of Drug Metabolism, W. Kalow. Pergamon, New York 1992; 95–175
   Google Scholar
• Evans D. A. P., Manley K. A., Mc Kusick V. A. Genetic control of isoniazid metabolism in man. British Medical Journal 1960; 2: 485–491
   PubMed Web of Science ®Google Scholar
• The Pink Sheet 19 April, 1993; 55(16)5–6, FDC Reports
   Google Scholar
• Foster R. T., Jamali F., Russell A. S., Alballa S. R. Pharmacokinetics of ketoprofen enantiomers in young and elderly arthritic patients following single and multiple doses. Journal of Pharmaceutical Science 1988; 77: 191–195
   PubMed Web of Science ®Google Scholar
• Funck-Brentano C., Thomas G., Jacqz-Aigrain E., Poirier J.-M., Simon T., Bereziat G., Jaillon P. Polymorphism of dextromethorphan metabolism: relationships between phenotype, genotype and response to the administration of encainide in humans. Journal of Pharmacology and Experimental Therapeutics 1992; 263: 780–786
   PubMed Web of Science ®Google Scholar
• Gill A., Addo M., Lewis J. Therapeutic interaction of L- and D-nebivolol in SHR. FASEB Journal 1990; 4: A747
   Google Scholar
• Gould R. J., Murphy K. M. M., Reynolds I. J., Snyder S. H. Antischizophrenic drugs of the diphenylbutylpiperidine type act as calcium channel antagonists. Proceedings of the National Academy of Sciences, USA 1983; 80: 5122–5125
   PubMed Web of Science ®Google Scholar
• Gram L. F., Fredricson-Overo K. Drug interaction: inhibitory effects of neuroleptics on metabolism of tricyclic antidepressants in man. British Medical Journal 1972; 1: 463–465
   PubMed Web of Science ®Google Scholar
• Guengerich F. P., Distlerath L M., Reilly P. E. B., Wolff T., Shimada T., Umbenhaur D. R., Martin M. V. Human-liver cytochromes P450 involved in polymorphisms of drug oxidation. Xenobiotica 1986; 16: 367–378
   PubMed Web of Science ®Google Scholar
• Hallen B., Magnusson A., Bogentoft S., Ekelund P. Single- and multiple-dose pharmacokinetics of terodiline in geriatric patients. European Journal of Clinical Pharmacology 1988; 34: 291–297
   PubMed Web of Science ®Google Scholar
• Herbert M. F., Roberts J. P., Prueksaritanont T., Benet L. Z. Bioavailability of cyclosporine with concomitant rifampin administration is markedly less than predicted by hepatic enzyme induction. Clinical Pharmacology and Therapeutics 1992; 52: 453–457
   PubMed Web of Science ®Google Scholar
• Hirschfeld S., Jarosinski P. Drug interaction of terfenadine and carbamazepine. Annals of Internal Medicine 1993; 118: 907–908
   PubMed Web of Science ®Google Scholar
• Honig P. K., Wortham D. C., Zamani K., Conner D. P., Mullin J. C., Cantilena L. R. Terfenadine-ketoconazole interaction. Journal of the American Medical Association 1993; 269: 1513–1518
   PubMed Web of Science ®Google Scholar
• Hsyu P. H., Giacomini K. M. Stereoselective renal clearance of pindolol in humans. Journal of Clinical Investigation 1985; 76: 1720–1726
   PubMed Web of Science ®Google Scholar
• Idle J. R., Smith R. L. The debrisoquine hydroxylation gene: a gene of multiple consequences. Proceedings of the Second World Congress of Clinical Pharmacology and Therapeutics, L. Lemberger, M. M. Reidenberg. The American Society of Pharmacology and Experimental Therapeutics, Bethesda, MarylandUSA 1984; 148–164
   Google Scholar
• Inaba T., Nakano M., Otton S. V., Mahon W. A. C., Kalow W. A human cytochrome P-450 characterised by inhibition studies as the sparteine-debrisoquine monooxygenase. Canadian Journal of Physiology and Pharmacology 1984; 17: 488–489
   Google Scholar
• Johnsson G., Jordo L., Lundborg P., Regardh C.-G., Ronn O. Plasma levels and pharmacological effects of metoprolol administered as a controlled-release (durules) and ordinary tablets in healthy volunteers. International Journal of Clinical Pharmacology, Therapy and Toxicology 1980; 18: 292–297
   PubMedGoogle Scholar
• Kamal A., Koch I. M. Pharmacokinetic studies of benoxaprofen in geriatric patients. European Journal of Rheumatology and Inflammation 1982; 5: 76–81
   PubMed Web of Science ®Google Scholar
• Karim A. K. M. B., Elfellah M. S., Evans D. A. P. Human acetylator polymorphism: estimate of allele frequency in Libya and details of global distribution. Journal of Medical Genetics 1981; 18: 325–330
   PubMed Web of Science ®Google Scholar
• Laplanche R., Fertil B., Nuesch E., Jais J.-P., Neiderberger W., Steimer J.-L. Exploratory analysis of population pharmacokinetic data from clinical trials with application to isradipine. Clinical Pharmacology and Therapeutics 1991; 50: 39–54
   PubMed Web of Science ®Google Scholar
• Larsson-Backstrom C., Arhenius E., Sagge K. Comparison of the calcium antagonistic effects of terodiline, nifedipine and verapamil. Acta Pharmacologica et Toxicologia 1985; 57: 8–17
   PubMedGoogle Scholar
• Leibbrandt D. M., Day R. O. Cyclosporin and calcium channel blockers: an exploitable drug interaction?. Medical Journal of Australia 1992; 157: 296–297
   PubMed Web of Science ®Google Scholar
• Lennard M. S., Tucker G. T., Woods H. F. The polymorphic oxidation of β-adrenoceptor antagonists: clinical pharmacokinetic considerations. Clinical Pharmacokinetics 1986; 11: 1–17
   PubMed Web of Science ®Google Scholar
• Lima J. J., Boudoulas H., Shields B. J. Stereoselective pharmacokinetics of disopyramide enantiomers in man. Drug Metabolism and Disposition 1985; 13: 572–577
   PubMed Web of Science ®Google Scholar
• Meyer U. A., Skoda R. C., Zanger U. M., Heim M., Broly F. The genetic polymorphism of debrisoquine/sparteine metabolism—molecular mechanisms. Pharmacogenetics of Drug Metabolism, W. Kalow. Pergamon, New York 1992; 609–623
   Google Scholar
• Morgan M. Y., Reshef R., Shah R. R., Oates N. S., Smith R. L., Sherlock S. Impaired oxidation of debrisoquine in patients with perhexiline liver injury. Gut 1984; 25: 1057–1064
   PubMed Web of Science ®Google Scholar
• Murray M. P450 enzymes: inhibition mechanisms, genetic regulation and effects of liver disease. Clinical Pharmacokinetics 1992; 23: 132–146
   PubMed Web of Science ®Google Scholar
• Oates N. S., Shah R. R., Idle J. R., Smith R. L. Influence of oxidation polymorphism on phenformin kinetics and dynamics. Clinical Pharmacology and Therapeutics 1983; 34: 827–834
   PubMed Web of Science ®Google Scholar
• Otton S. V., Crewe H. K., Lennard M. S., Tucker G. T., Woods H. F. Use of quinidine inhibition to define the role of the sparteine/debrisoquine cytochrome P-450 in metoprolol oxidation by human liver microsomes. Journal of Pharmacology and Experimental Therapeutics 1988; 247: 242–247
   PubMed Web of Science ®Google Scholar
• Otton S. V., Inaba T., Kalow W. Competitive inhibition of sparteine oxidation in human liver by β-adrenoceptor antagonists and other cardiovascular drugs. Life Sciences 1984; 34: 73–80
   PubMed Web of Science ®Google Scholar
• Sakai M., Ohkawa S., Kaku T., Kuboki K., Chida K., Imai T. Pharmacokinetics of flosequinan in elderly patients with chronic congestive heart failure. European Journal of Clinical Pharmacology 1993; 44: 387–389
   PubMed Web of Science ®Google Scholar
• Sesardic D., Boobis A. R., Murray B. P., Segura J., De La Torre R., Davies D. S. Furafylline is a potent and selective inhibitor of cytochrome P-450 1A2 in man. British Journal of Clinical Pharmacology 1990; 29: 651–663
   PubMed Web of Science ®Google Scholar
• Shah R. R., Oates N. S., Idle J. R., Smith R. L., Lockhart J. D. F. Impaired oxidation of debrisoquine in patients with perhexiline neuropathy. British Medical Journal 1982; 284: 295–299
   PubMed Web of Science ®Google Scholar
• Sheiner L. B., Beal S. L., Sambol N. C. Study designs for dose-ranging. Clinical Pharmacology and Therapeutics 1989; 46: 63–77
   PubMed Web of Science ®Google Scholar
• Sheiner L. R., Benet L. Z. Premarketing observational studies of population pharmacokinetics of new drugs. Clinical Pharmacology and Therapeutics 1985; 38: 481–487
   PubMed Web of Science ®Google Scholar
• Sheiner L. B., Rosenberg B., Marathe V. V. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. Journal of Pharmacokinetics and Biopharmaceutics 1977; 5: 445–479
   PubMedGoogle Scholar
• Sindrup S. H., Brosen K., Bjerring P., Arendt-Neilsen L., Larsen U., Angello H. R., Gram L. F. Codeine increases pain thresholds to copper vapor laser stimuli in extensive but not poor metabolisers of sparteine. Clinical Pharmacology and Therapeutics 1990; 48: 686–693
   PubMed Web of Science ®Google Scholar
• Singlas E., Goujet M. A., Simon P. Pharmacokinetics of perhexiline maleate in anginal patients with and without peripheral neuropathy. European Journal of Clinical Pharmacology 1978; 14: 195–201
   PubMed Web of Science ®Google Scholar
• Smith D. A., Jones B. A. Speculations on the substrate structure-activity relationship (SSAR) of cytochrome P-450 enzymes. Biochemical Pharmacology 1992; 44: 2089–2098
   PubMed Web of Science ®Google Scholar
• Speirs C. J., Murray S., Boobis A. R., Seddon S. E., Davies D. S. Quinidine and the identification of drugs whose elimination is impaired in subjects classified as poor metabolisers. British Journal of Clinical Pharmacology 1986; 22: 739–743
   PubMed Web of Science ®Google Scholar
• Tarrus E., Cami J., Roberts D. J., Spickett R. G. W., Celdran E., Segura J. Accumulation of caffeine in healthy volunteers treated with furafylline. British Journal of Clinical Pharmacology 1987; 23: 9–18
   PubMed Web of Science ®Google Scholar
• Temple R. Dose-response and registration of new drugs. Dose-Response Relationships in Clinical Pharmacology Esteve Foundation Symposia, L. Lasagna, S. Erill, C. A. Naranjo. Excerpta Medica, Amsterdam 1989; Vol. 3: 145–170
   Google Scholar
• Toon S., Davidson E. M., Garstang F. M., Batra H., Bowes R. J., Rowland M. The racemic metoprolol H2-antagonist interaction. Clinical Pharmacology and Therapeutics 1988; 43: 283–289
   PubMed Web of Science ®Google Scholar
• Wagner F., Jahnchen E., Trenk D., Eichelbaum M., Harnasch P., Hauf G., Roskamm H. Severe complications of antianginal drug therapy in a patient identified as a poor metabolizer of metoprolol, propafenone, diltiazem and sparteine. Klinische Wochenschrift 1987; 65: 1164–1168
   PubMedGoogle Scholar
• Wang T., Roden D. M., Wolfenden H. T., Woosley R. L., Wood A. J., Wilkinson G. R. Influence of genetic polymorphism on the metabolism and disposition of encainide in man. Journal of Pharmacology and Experimental Therapeutics 1984; 228: 605–611
   PubMed Web of Science ®Google Scholar
• Whiting B., Kelman A. W., Grevel J. Population pharmacokinetics: theory and clinical application. Clinical Pharmacokinetics 1986; 11: 387–401
   PubMed Web of Science ®Google Scholar
• Woosley R. L., Chen Y., Freiman J. P., Gillis R. A. Mechanism of the cardiotoxic actions of terfenadine. Journal of the American Medical Association 1993; 269: 1532–1536
   PubMed Web of Science ®Google Scholar
• Wright G. J., Leeson G. A., Zeiger A. V., Lang J. F. The absorption, excretion and metabolism of perhexiline maleate by the human. Postgraduate Medical Journal 1973; 49: 8–15, Suppl. 3
   PubMed Web of Science ®Google Scholar
• Zoble R. G., Kirsten E. B., Brewington J. the Group Propafenone Research 1989 Pharmacokinetic and pharmacodynamic evaluation of propafenone in patients with ventricular arrhythmia. Clinical Pharmacology and Therapeutics, 45: 535–541
   PubMed Web of Science ®Google Scholar