Clinical Pharmacokinetics and Pharmacodynamics

Dosage can be defined as the amount of a drug administered over time, e.g., in repeat dose studies (Heilman, 2006). 

As was noted in Chapter 4, pharmacokinetic and pharmacodynamic effects are studied in nonclinical research. These topics are also of critical importance in clinical investigations. A drug s pharmacokinetics and pharmacodynamics are of considerable interest to clinicians who may prescribe the drug to patients once it is approved. Meaningful decisions about a drug s optimal use can only be made with an understanding of the time course of events that occur after the drug s administration, and both pharmacokinetics and pharmacodynamics are concerned with this time course. By consideration of the pharmacokinetic processes of absorption, distribution, metabolism, and excretion (ADME), the 

In both pharmacokinetic and pharmacodynamic considerations, an important emphasis concerns the rate at which events occur and the rate at which circumstances change. The pharmacokinetic phase covers the relationship between drug input and the concentration achieved over time. The pharmacodynamic phase covers the relationship between concentration and the therapeutic effect over time (toxicodynamics is concerned with the relationship between concentration and adverse effects over time). 

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Patton, J.S., Bukar, J.G., and Eldon, M.A. 2004. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clinical Pharmacokinetics 43(12), 781-801. 

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Salva, P. and Costa, J. (1995) Clinical pharmacokinetics and pharmacodynamics of Zolpidem. Clin Pharmacokinet 29 142-153. 

Jann, M.W., Shirley, K.L., Small, G.W. Clinical pharmacokinetics and pharmacodynamics of cholinesterase inhibitors. Clin. Phannacokin. 41, 719-739, 2002. 

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Steiner JF. Clinical pharmacokinetics and pharmacodynamics of finasteride. Clin Pharmacokinet 1996 30(l) 16-27. 

Lindholm A, Jacobsen LV. Clinical pharmacokinetics and pharmacodynamics of insulin aspart. Clin Pharmacokinet 2001 40(9) 641-59. 

Hashimoto S, Kobayashi A. Clinical pharmacokinetics and pharmacodynamics of glyceryl trinitrate and its metabolites. Clin Pharmacokinet. 2003 42 205-221. 

New formulations for inhaled insulin are currently under development by several companies, and are at various stages of clinical trials. Among these, AERx is in advanced Phase III trials [59], while Exubera has been approved in the USA and Europe. The clinical pharmacokinetics and pharmacodynamics of inhaled insulin were recently reviewed by Eldon et al. [59]. 

Davies NM, McLachlan AJ, Day RO, Williams KM. Clinical pharmacokinetics and pharmacodynamics of cele-coxib a selective cyclo-oxygenase-2 inhibitor. Clin Pharmacokinet 2000 38(3) 225 12. 

Morgan J, Mclean A (1995) Clinical pharmacokinetic and pharmacodynamic considerations in patients with liver disease. Clin Pharmacokinet 29 370-391. 

Knauf H, Mutschler E. Clinical pharmacokinetics and pharmacodynamics of torasemide. Clin Pharmacokinet 1998 34(l) l-24. 

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