PMID: 7014827Feb 1, 1981Paper

A standard approach to compiling clinical pharmacokinetic data

Journal of Pharmacokinetics and Biopharmaceutics
L B SheinerL A Pagliaro

Abstract

A standard format for a Clinical Pharmacokinetic Summary is proposed. It consists of a heading, tables, notes, and references for each drug reviewed. The table presents a unified and logical set of clinically useful population pharmacokinetic parameters. They concern four major areas: absorption, distribution, elimination, and the relationship of concentration to effect. Within each major group, parameters dealing with extents and rates of processes are given. Each such parameter is really two: a population mea value (for example, average volume of distribution) and the standard deviation of individual values about this mean. The first value allows individual predictions of dosage or drug level to be made; the second allows computation of the likely proximity of subsequently observed quantities to those predictions. The table presents single consensus values for each population parameter, rather than a list of values. A procedure for computing these consensus values, and for revising them in the light of new data, or reinterpreted old data, is given. Examples of Summaries are given. The method appears applicable to a variety of drugs. We suggest our approach as a standard one for preparing Clinical Pharmacokinetic Summaries, an...Continue Reading

References

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Citations

Jan 1, 1983·European Journal of Clinical Pharmacology·M WeissW Förster
Jan 1, 1985·European Journal of Clinical Pharmacology·D Brockmeier, J Ostrowski
Jun 1, 1988·Computers and Biomedical Research, an International Journal·A IliadisJ P Cano
May 1, 1986·International Journal of Bio-medical Computing·A IliadisJ P Cano
Jan 1, 1982·Pharmacology & Therapeutics·N H Holford, L B Sheiner
Jul 1, 1982·Journal of Clinical Pharmacology
Oct 19, 2016·Clinical Pharmacokinetics·Bishoy KamelRichard O Day
Jun 1, 1988·Journal of Pharmacokinetics and Biopharmaceutics·A MalletF Lokiec
Apr 22, 1999·Biopharmaceutics & Drug Disposition·K NishiharaT Iga
Jul 1, 1986·Biopharmaceutics & Drug Disposition·J Hirtz
Jul 28, 2007·Clinical Pharmacokinetics·Richard O DayKenneth M Williams
Jan 9, 2009·Paediatric Drugs·Facundo Garcia-BournissenGideon Koren
Nov 1, 1988·Biomedical & Environmental Mass Spectrometry·F R RubioE K Fukuda
Jun 8, 2004·The Veterinary Record·M R Martínez-LarrañagaC O De la Cruz
Jul 1, 1986·Drug Intelligence & Clinical Pharmacy·P R MayerN K Eberhard
Jan 19, 2011·Clinical Pharmacokinetics·Garry G GrahamKenneth M Williams

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