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      Population Pharmacokinetic/Pharmacodynamic Analysis of Nociceptive Pain Models Following an Oral Pregabalin Dose Administration to Healthy Subjects

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          Abstract

          A battery of pain models can be used in clinical trials to investigate the efficacy and to establish the concentration‐effect relationship of novel analgesics. This study quantified the pharmacokinetics ( PK) of pregabalin after a single oral dose of 300 mg and the pharmacodynamics ( PD) on the pain tolerance threshold ( PTT) of the cold pressor, electrical stimulation, the pressure pain model, and on the pain detection threshold of a contact heat pain model. The PK were best described using a one‐compartment model with lag time, linear absorption, and linear elimination. The PTT of the cold pressor showed a negative linear decrease over time without pregabalin. A linear drug effect was identified on the PTT of the cold pressor test and an on/off effect for the electrical stimulation PTT. No PK/ PD relationship could be identified on the pressure pain and heat pain test. Citation:

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          Prediction of creatinine clearance from serum creatinine.

          A formula has been developed to predict creatinine clearance (Ccr) from serum creatinine (Scr) in adult males: (see article)(15% less in females). Derivation included the relationship found between age and 24-hour creatinine excretion/kg in 249 patients aged 18-92. Values for Ccr were predicted by this formula and four other methods and the results compared with the means of two 24-hour Ccr's measured in 236 patients. The above formula gave a correlation coefficient between predicted and mean measured Ccr's of 0.83; on average, the difference predicted and mean measured values was no greater than that between paired clearances. Factors for age and body weight must be included for reasonable prediction.
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            The short-form McGill Pain Questionnaire.

            A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS). The SF-MPQ scores obtained from patients in post-surgical and obstetrical wards and physiotherapy and dental departments were compared to the scores obtained with the standard MPQ. The correlations were consistently high and significant. The SF-MPQ was also shown to be sufficiently sensitive to demonstrate differences due to treatment at statistical levels comparable to those obtained with the standard form. The SF-MPQ shows promise as a useful tool in situations in which the standard MPQ takes too long to administer, yet qualitative information is desired and the PPI and VAS are inadequate.
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              Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development

              Modeling is an important tool in drug development; population modeling is a complex process requiring robust underlying procedures for ensuring clean data, appropriate computing platforms, adequate resources, and effective communication. Although requiring an investment in resources, it can save time and money by providing a platform for integrating all information gathered on new therapeutic agents. This article provides a brief overview of aspects of modeling and simulation as applied to many areas in drug development.
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                Author and article information

                Contributors
                m.j.van.esdonk@lacdr.leidenuniv.nl
                Journal
                CPT Pharmacometrics Syst Pharmacol
                CPT Pharmacometrics Syst Pharmacol
                10.1002/(ISSN)2163-8306
                PSP4
                CPT: Pharmacometrics & Systems Pharmacology
                John Wiley and Sons Inc. (Hoboken )
                2163-8306
                13 August 2018
                September 2018
                : 7
                : 9 ( doiID: 10.1002/psp4.2018.7.issue-9 )
                : 573-580
                Affiliations
                [ 1 ] Centre for Human Drug Research Leiden The Netherlands
                [ 2 ] Division of Systems Biomedicine and Pharmacology Leiden Academic Centre for Drug Research Leiden University Leiden The Netherlands
                [ 3 ] Department of Clinical Pharmacy and Pharmacology University Medical Center Groningen University of Groningen Groningen The Netherlands
                Author notes
                [*] [* ]Michiel J. van Esdonk ( m.j.van.esdonk@ 123456lacdr.leidenuniv.nl )
                Author information
                http://orcid.org/0000-0001-8159-0273
                Article
                PSP412318
                10.1002/psp4.12318
                6157667
                30043517
                633e606b-4e4d-4569-b347-a7442d77147d
                © 2018 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 26 February 2018
                : 23 May 2018
                Page count
                Figures: 3, Tables: 3, Pages: 8, Words: 5966
                Categories
                Article
                Research
                Articles
                Custom metadata
                2.0
                psp412318
                September 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.9 mode:remove_FC converted:26.09.2018

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