Abstract
Clinical pharmacology is the science of drugs and their clinical use. One of the main goals of clinical pharmacology is to improve the safety and efficacy of any drug therapy. To optimize the dose regimen, the relationship between dose, concentrations, and response is investigated in more detail. One of the early results of these investigations was that most drugs obtain an optimal therapeutic response within a limited range of concentrations. To achieve the target response in each patient, his/her dose regimen should be adjusted appropriately to achieve this therapeutic target concentration range. To confirm that the target concentrations had been achieved, a few concentrations were measured per patient at predefined time points. And indeed, when clinical pharmacologists introduced such therapeutic drug monitoring (TDM) as therapy control, safety and efficacy of the drug therapy were improved.
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REFERENCES AND FURTHER READING
Arnett FC, Edworthy SM, Bloch DA, Mcshane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, Medsger TA Jr, Mitchell DM, Neustadt DH, Pinals RS, Schaller JG, Sharp JT, Wilder RL, Hunder GG (1988) The American rheumatism association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 31(3):315–324
Boeckmann AJ, Sheiner LB, Beal SL Choosing among models. In: Model building [3], Chap. 6, pp 48–49
Boeckmann AJ, Sheiner LB, Beal SL (1994) NONMEM users guide – Part V Introductory Guide. NONMEM Project Group, C255 University of California at San Francisco, San Francisco, CA 94143
Collett D (2003) Modelling binary data, 2nd edn. Chapman & Hall, London
Horn W, Oed C (2003) Comparative trial of the efficacy and safety of leflunomide 10 mg versus 20 mg daily doses in patients with active rheumatoid arthritis. Technical Report F2002CLN00017, Aventis Pharma, Frankfurt/Main
Køber L, Torp-Pedersen C, McMurray JJV, Gøtzsche O, Lévy S, Crijns H, Amlie J, Carlsen J, for the Dronedarone Study Group (2008) Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 358:2678–2687
Rowland M, Tozer TN (1989) Clinical pharmacokinetics: concepts and applications. Lea & Febinger, Philadelphia
Rozman B (2002) Clinical pharmacokinetics of leflunomide. Clin Pharmacokinet 41(6):421–430, PMID: 12074690
Schoemaker RC, Cohen AF (1996) Estimating impossible curves using NONMEM. Brit J Clin Pharmacol 42(3):283–290, PMID: 8877017
Sheiner LB, Beal SL (1982) Bayesian individualization of pharmacokinetics: simple implementation and comparison with non-Bayesian methods. J Pharm Sci 71(12):1344–1348
Sheiner LB, Rosenberg B, Marathe VV (1977) Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm 5(5):445–479
Singh BN, Connolly SJ, Crijns HGJM, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH, for the EURIDIS and ADONIS Investigators (2007) Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 357:987–999
Weber W, Harnisch L (1997) Use of a population approach to the development of leflunomide: a new disease-modifying drug in the treatment of rheumatoid arthritis. In: Balant LP, Aarons L (eds) The population approach: measuring and managing variability in response concentration and dose, COST B12. Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
Weber W, Harnisch L (2002) Arava: comparison of population pkpd between Caucasian and Japanese population. Technical report, Aventis, April 10 2002
Weber W, Rueppel D (2004) Arava: comparative trial of the efficacy and safety of leflunomide 10 mg versus 20 mg daily doses in patients with active rheumatoid arthritis. Technical report, Aventis Pharma
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Weber, W., Martinez, JM., Rüppel, D., Lockwood, G. (2011). Population Pharmacokinetics in Clinical Pharmacology. In: Vogel, H.G., Maas, J., Gebauer, A. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-89891-7_18
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DOI: https://doi.org/10.1007/978-3-540-89891-7_18
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-89890-0
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