Population pharmacokinetic

Population pharmacokinetics is the application of pharmacokinetic and statistical methods to sparse data to derive a pharmacokinetic profile of central tendency. 

Poor Metabolizer Phenotype Population Pharmacokinetics Positron Emission Tomography Post-translational Modification Potassium Channels Potassium Competitive Acid Blockers PP... 

Jen J, Laughlin M, Chung C, Heft S, Affrime MB, Gupta SK, Glue P, Hajian G (2002) Ribavirin dosing in chronic hepatitis C application of population pharmacokinetic-pharmacodynamic models, Clin Pharmacol Ther 72 349-361... 

Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. / Pharmacokinet Biopharm 1981 9 635-51. 

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research (CBER). Guidance for Industry Population Pharmacokinetics. http //www.fda.gov/cder/guidance/1852fnl.pdf (accessed October 1,... 

Sheiner LB, Ludden TM. Population pharmacokinetics/dynamics. Annu Rev Pharmacol Toxicol 1992 32 185-209. 

Jen, J.F. et al., Population pharmacokinetic analysis of pegylated interferon alfa-2b and interferon alfa-2b in patients with chronic hepatitis C, Clin. Pharmacol. Then, 69, 407, 2001. 

Homestam, B., Jerling, M., Karlsson, M.O., and Held, P. DAAf Trial Group, Intravenously administered digoxin in patients with acute atrial fibrillation a population pharmacokinetic/pharmacodynamic analysis based on the digitalis in acute atrial fibrillation trial, Eur.. Clin. Pharmacol., 58, 747-755, 2003. 

Svensson, U.S., Alin, H., Karlsson, M.O., Bergqvist, Y., and Ashton, M., Population pharmacokinetic and pharmacodjmamic modeling of artemisinin and mefloquine enantiomers in patients with falciparum malaria, Eur.. Clin. Pharmacol, 58, 339-351, 2002. 

Csajka, C., Buclin, T., Fattinger, K., Brunner, H.R., and Biollaz, Population pharmacokinetic-pharmacodynamic modelling of angiotensin receptor blockade in healthy volunteers, Clin. Pharmacokinet., 41, 137-152, 2002. 

Tod, M., Minozzi, C., Beaucaire, G., Ponsonnet, D., Gougnard, J., and Petitjean, O., Isepamicin in intensive care unit patients with nosocomial pneumonia population pharmacokinetic-pharmacodynamic study, /. Antimicrob. Chemother., 44, 99-108,1999. 

HesseUnk, D. A., Van Gelder, T., Van Schaik, R. H., et al. (2004) Population pharmacokinetics of cyclosporine in kidney and heart transplant recipients and the influence of ethnicity and genetic polymorphisms in the MDR-1, CYP3A4, and CYP3A5 genes. Clin. Pharmacol. Ther. 76, 545-556. 

Boni IP, Leister C, Bender G Fitzpatrick V, Twine N, Stover J, Domer A, Immermann F, Burczynski ME. (2005) Population pharmacokinetics of CCI-779 Correlations to safety and pharmacogenomic responses in patients with advanced renal cancer. Clin Pharmacol Ther 77 76-89. 

Woo S, Gardner ER, Chen X, Ockers SB, Baum CE, Sissung TM, Price DK, Erye R, Piekarz RL, Bates SE, Figg WD. (2009) Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma. Clin Cancer Res 15 1496-1503. 

Samara E, Granneman R. Role of population pharmacokinetics in drug development a pharmaceutical perspective. Clin Pharmacokinet 1997 4 294-312. 

Tett SE, Holford NHG, McLachlan AJ. Population pharmacokinetics and pharmacodynamics. An underutilized resource. Drug Inf J 1998 32 693-710. 

First, they can be used to generate hypotheses. Because of their nature when data are extracted from the literature across diverse study protocols meta-analyses can be extremely useful in generating h)rpotheses particularly concerning subgroups of patients. In this sense their use mirrors one potential objective of a population pharmacokinetic study that may be to determine interesting covaiiates, which influence drug... 

Pharmacokinetics Population pharmacokinetic analysis gave the following values for a reference patient (white male, 45 years of age, with a body weight of 80 kg and no proteinuria) Systemic clearance is 15 mL/h, volume of central compartment is P.1160... 

Clinical pharmacology carries out all phase 1 smdies and in some companies also proof of principle smdies. Usually clinical pharmacokinetics (including PK/PD modeling, simulation and population pharmacokinetics) also belongs to the domain of... 

Mamiya K, leiri I, Shimamoto J, Yukawa E, Imai J, Ni-nomiya H et al. The effects of genetic polymorphims of CYP2C9 and CYP2C19 on phenytoin metabohsm in Japanese adult patients with epilepsy studies in stereoselective hydroxylation and population pharmacokinetics. Epilepsia 1998 29(12) 1317-23. 

FIGURE 4.4 A Lithium plasma concentration time profile based on a population pharmacokinetics model (Taright et al., 1994). Closed circles are the actual measured lithium concentrations broken lines represent the therapeutic range (0.6-1.2 mmol/L). B Individualized lithium plasma concentration time profile based on the population model with feedback of measured concentrations (Bayesian recalculation). Closed circles are the measured lithium concentrations. The second part of the curve is the predicted lithium concentration profile after increasing the dose to 1000 mg lithium carbonate twice daily, based on a target of 0.6-1.2 mmol/L (broken lines). 

Sheiner, L.B., and Benet, L.Z. (1985) Premarketing observational studies of population pharmacokinetics of new drugs. Clin Pharmacol Eher 38 481-488. 

Rostami-Hodjegan A, Wohf K, Hay AWM, Raistrick D, Calvert R Tucker GT (1999). Population pharmacokinetics in opiate users characterization of time dependent changes. British Journal of Clinical Pharmacology, 47, 974-86... 

Viewed from this perspective, clinical trials are in essence population pharmacokinetic studies in which the goal is to determine the dose of the drug needed to achieve the optimal drug level (i.e., concentration) in the average person enrolled in the study. The concept of the average person is critical because humans are not all the same including how they respond to a drug. That is the reason for the third variable in Eg.1. 

Fruit juices such as grapefruit, orange, and apple may reduce the bioavailability and exposure of fexofenadine. This is based on the results from three clinical studies using histamine-induced skin wheals and flares coupled with population pharmacokinetic analysis. Therefore, to maximize the effects of fexofenadine, it is recommended that ALLEGRA-D 24 HOUR should be taken with water... 

Bouillon, T., Kietzmann, D., Port, R., Meineke, I., Hoeft, A. Population pharmacokinetics of piritramide in surgical patients, Anesthesiology 1999, 90, 7-15. 

Some strategies have been put in place to mitigate or minimize the risks that arise from such unmanageable food effects for Compound A. An extensive population pharmacokinetic-pharmacodynamic program had been designed for Phases ll/lll studies of Compound A a number of... 

Bonate PL, Floret S, Bentzen C. Population pharmacokinetics of APOMINE a meta-analysis in cancer patients and healthy maldSr J Clin Pharmacol, 2004 58 142-155. 

Aarons, L. (1999). Software for population pharmacokinetics and pharmacodynamics. Clin. Pharmacokinet. 36 255-264. 

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