Dear All,Back to the Top
I am new to Pharmacokinetics. I have read some research articles regarding
Population Pharmacokinetics and also PBPK modelling.I could not get any
clearcut idea about their use and application.
in this regard any body can suggest me any review articles or textbooks
for the same.thank you in advance.bye.
Dear SantoshBack to the Top
For population pharmacokinetics, I recommend the following review papers.
Anaesthesia Research Group,
Peninsula Medical School, Universities of Exeter & Plymouth, UK
Rosenbaum SE, Carter AA, Dudley MN: Population Pharmacokinetics:
Fundamentals, Methods and Applications. Drug Development and Industrial
Wright PMC: Population based pharmacokinetic analysis: why do we need it;
what is it; and what has it told us about anaesthetics? British Journal of
Whiting B, Kelman AW, Grevel J: Population Pharmacokinetics: Theory and
Clinical Application. Clinical Pharmacokinetics 1986;11:387-401.
Sheiner LB, Grasela TH: An Introduction to Mixed Effects Modelling:
Concepts, Definitions and Justification. Journal of Pharmacokinetics and
Sheiner LB, Ludden TM: Population Pharmacokinetics/dynamics. Annu Rev
Pharmacol Toxicol. 1992;32:185-209.
Dear Dr. Tata,Back to the Top
I recommend the following articles and book chapters:
1.Jelliffe RW. et al. Population PK/PD modeling:
nonparametric methods. Ther Drug Monit.
2. Jelliffe RW. et al. Model-based, goal-oriented,
therapy. Clin Pharmacokinet. 1998;34:57-77
3. Steimer J-L. et al. The population
application in clinical pharmacology and drug
development. in: Handbook
of Exp.Pharmacology. Pharmacokinetic of drugs. vol.
Springer Verlag, Heidelberg, 1994
4. Sheiner LB and Ludden TM. Population PK/PD. Annu
5. Ludden TM. Population pharmacokinetics. J Clin
6. Temple R. The clinical investigation of drug use by
and Drug guidelines. Clin Pharmacol Ther.
7. Beal SL. and Sheiner LB. Methodology of population
PK. in: Drug fate
and metabolism. Eds:Garrett ER. and Hirtz JL. pp.
Inc, New York and Basel, 1985
8. Sheiner LB. The population approach to PK data
and standard data analysis methods. Drug Metab Revs.
9.Sheiner LB et al. Forecasting individual
Pharmacol Ther. 1979;26:294-305.
I think the above papers will help you in
understanding the conceptual
genesis and framework of the population approach and
in clinical settings and in early stages of drug
Dimiter Terziivanov, MD,PhD,DSc, Professor
Head, Department of Clinical Pharmacology and
Clinic for Therapeutics and Clinical Pharmacology,
Univ Hosp "St. I.Rilsky",
15 Acad. I. Geshov st, 1431 Sofia, Bulgaria
Tel:(+ 359 2)8510639;(+ 359 2)5812 828.
Fax:(+ 359 2)8519309. e-mal: terziiv.-a-.yahoo.com
For Physiological-Toxicokinetic modelling there is a whole issue ofBack to the Top
Toxicology Letters devoted to this - volume 138 (nos.1-2), 2003, which is an
excellent starting point. This is about general chemical toxicity though,
Dear Santosh:Back to the Top
Population PK/PD modeling is what one usually uses to describe the
behavior of drugs these days, rather than linear or nonlinear regression,
for example. It is much more efficient and capable, and makes much better
use of the information contained in the data analyzed.
There are 2 basic types of approach to the problem - parametric and
nonparametric. Both use a structural model based on differential equations,
and both have parameters. The parametric approach describes these
parameters in terms of the other parameters that describe the shape of the
normal Gaussian curve, namely means and variances.
The nonparametric approach is not limited to that, and instead computes
the most likely entire distribution of the parameter values given the data
and the weighting scheme used, without making any assumptions about its
shape, such as normal, lognormal, etc. It also computes means and variances.
You might look at "Applications of Pharmacokinetic Principles in Drug
Development", edited by Rajesh Krishna, Kluwer Academic/Plenum Publishers,
ISBN 0-306-47766-1, 2003. It has a chapter on Population Pharmacokinetic
and Pharmacodynamic Modeling, pages 373-404. It also has a comparison of
the two approaches, with their various strengths and weaknesses.
You might also ask why one does this. One important reason is to develop
the best dosage regimen possible. Here the two approaches really differ, as
with the nonparametric approach one can estimate the expected degree of
precision (weighted squared error) with which a dosage regimen will fail to
hit its desired target goal(s). It does this using "multiple model" dosage
design, which makes essentially optimal mathematical used of all available
information in the population model and in whatever serum concentrations
have been obtained from an individual patient to date. This multiple model
Bayesian adaptive control of dosage regimens appears to us to offer the
best and most precise dosage regimens currently available. A beta version
of this clinical software can be downloaded from www.lapk.org/beta. The
method is also described in the same book, in "Optimizing Individualized
Dosage Regimens of Potentially Toxic Drugs", pages 477-529.
You might also go to our web site www.lapk.org and click around under the
various topics there.
Very best regards,
Roger W. Jelliffe, M.D. Professor of Medicine,
Division of Geriatric Medicine,
Laboratory of Applied Pharmacokinetics,
USC Keck School of Medicine
2250 Alcazar St, Los Angeles CA 90033, USA
Phone (323)442-1300, fax (323)442-1302, email= jelliffe.aaa.usc.edu
Our web site= http://www.lapk.org
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