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J. Fisher, Huali Wu, M. Cohen-Wolkowiez, K. Watt, Jian Wang, G. Burckart, J. Troutman, Xiaoxia Yang (2019)
Predicting the pharmacokinetics of piperacillin and tazobactam in preterm and term neonates using physiologically based pharmacokinetic modelingComputational Toxicology
C. Emoto, T. Johnson, S. Neuhoff, David Hahn, A. Vinks, T. Fukuda (2018)
PBPK Model of Morphine Incorporating Developmental Changes in Hepatic OCT1 and UGT2B7 Proteins to Explain the Variability in Clearances in Neonates and Small InfantsCPT: Pharmacometrics & Systems Pharmacology, 7
Jean-Marc Tréluyer, Gildas Gueret, Gérard Chéron, M. Sonnier, Thierry Cresteil (1997)
Developmental expression of CYP2C and CYP2C-dependent activities in the human liver: in-vivo/in-vitro correlation and inducibility.Pharmacogenetics, 7 6
W. Stigelman, P. D. (1986)
Goodman and Gilman's the Pharmacological Basis of TherapeuticsMilitary Medicine, 151
K. Abduljalil, Xian Pan, A. Pansari, M. Jamei, T. Johnson (2019)
A Preterm Physiologically Based Pharmacokinetic Model. Part I: Physiological Parameters and Model BuildingClinical Pharmacokinetics, 59
SN de Wildt (2001)
10.1067/mcp.2001.120683Clin Pharmacol Ther, 70
A. Fuchs, M. Guidi, E. Giannoni, D. Werner, T. Buclin, Nicolas Widmer, C. Csajka (2014)
Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates.British journal of clinical pharmacology, 78 5
P. Gal, J. Gilman (1993)
Drug Disposition in Neonates with Patent Ductus ArteriosusAnnals of Pharmacotherapy, 27
K. Beaumont, I. Gardner, Kathryn Chapman, M. Hall, M. Rowland (2011)
Toward an integrated human clearance prediction strategy that minimizes animal use.Journal of pharmaceutical sciences, 100 10
I Ince (2013)
10.1007/s40262-013-0050-0Clin Pharmacokinet, 52
Alonso Leon, K. Michienzi, C. Ma, A. Hutchison (2007)
Serum caffeine concentrations in preterm neonates.American journal of perinatology, 24 1
J. Coon (2010)
Goodman and Gilman's the Pharmacological Basis of TherapeuticsFocus on Alternative and Complementary Therapies, 7
J. Schüttler, H. Stoeckel (1982)
[Clinical pharmacokinetics of alfentanyl (author's transl)].Der Anaesthesist, 31 1
Ibrahim Ince, S. Wildt, Chenguang Wang, M. Peeters, J. Burggraaf, É. Jacqz-Aigrain, J. Anker, D. Tibboel, M. Danhof, C. Knibbe (2013)
Erratum to: A Novel Maturation Function for Clearance of the Cytochrome P450 3A Substrate Midazolam from Preterm Neonates to AdultsClinical Pharmacokinetics, 52
M. Jamei, S. Marciniak, Kairui Feng, A. Barnett, G. Tucker, A. Rostami-Hodjegan (2009)
The Simcyp population-based ADME simulator.Expert opinion on drug metabolism & toxicology, 5 2
J. Stevens, R. Hines, Chungang Gu, S. Koukouritaki, J. Manro, Peter Tandler, M. Zaya (2003)
Developmental Expression of the Major Human Hepatic CYP3A EnzymesJournal of Pharmacology and Experimental Therapeutics, 307
R. Gary, Matzke, Robert McGORY, C. Halstenson, A. Keane, A. Blair (1984)
Pharmacokinetics of vancomycin in patients with various degrees of renal functionAntimicrobial Agents and Chemotherapy, 25
B. Charles, S. Townsend, P. Steer, V. Flenady, P. Gray, A. Shearman (2008)
Caffeine Citrate Treatment for Extremely Premature Infants With Apnea: Population Pharmacokinetics, Absolute Bioavailability, and Implications for Therapeutic Drug MonitoringTherapeutic Drug Monitoring, 30
Shu-Ying Chang, Wenying Li, S. Traeger, Bei Wang, D. Cui, Hongjiang Zhang, B. Wen, David Rodrigues (2008)
Confirmation That Cytochrome P450 2C8 (CYP2C8) Plays a Minor Role in (S)-(+)- and (R)-(-)-Ibuprofen Hydroxylation in VitroDrug Metabolism and Disposition, 36
R. Gorodischer, M. Karplus (2004)
Pharmacokinetic aspects of caffeine in premature infants with apnoeaEuropean Journal of Clinical Pharmacology, 22
K. Allegaert (2017)
Better medicines for neonates: Improving medicine development, testing, and prescribing.Early human development, 114
A. Girardi, E. Raschi, S. Galletti, E. Poluzzi, G. Faldella, K. Allegaert, F. Ponti (2015)
Drug-Induced Renal Damage in Preterm Neonates: State of the Art and Methods for Early DetectionDrug Safety, 38
S. Beloica, S. Cvijić, M. Bogataj, J. Parojčić (2015)
In vitro-in vivo-in silico approach in biopharmaceutical characterization of ibuprofen IR and SR tablets.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 75
Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution. 2011. www.fda.gov/ drugs /drugs afety /ucm24 6002.htm
EV Capparelli (2001)
10.1177/00912700122010898J Clin Pharmacol, 41
Jason Moore, M. Gastonguay, C. Ng, S. Adeniyi-Jones, D. Moody, Wenfang Fang, M. Ehrlich, W. Kraft (2018)
The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence SyndromeClinical Pharmacology & Therapeutics, 103
L. Krishnan, S. George (1997)
Gentamicin therapy in preterms: a comparison of two dosage regimens.Indian pediatrics, 34 12
P. Sharma, S. Garg, A. Narang (2003)
Pharmacokinetics of Oral Ibuprofen in Premature InfantsThe Journal of Clinical Pharmacology, 43
B. Barzilay, I. Youngster, D. Batash, R. Keidar, S. Baram, M. Goldman, M. Berkovitch, E. Heyman (2011)
Pharmacokinetics of oral ibuprofen for patent ductus arteriosus closure in preterm infantsArchives of Disease in Childhood: Fetal and Neonatal Edition, 97
B Van Overmeire (2001)
10.1067/mcp.2001.118453Clin Pharmacol Ther, 70
N. Mansoor, T. Ahmad, Rafeeq Khan, Syed Sharib, I. Mahmood (2016)
Prediction of Clearance and Dose of Midazolam in Preterm and Term Neonates: A Comparative Study Between Allometric Scaling and Physiologically Based Pharmacokinetic ModelingAmerican Journal of Therapeutics, 26
Anthony Killian, Peter Davis, Richard Stiller, Robert Cicco, D. Cook, Robert Guthrie (1990)
Influence of gestational age on pharmacokinetics of alfentanil in neonates.Developmental pharmacology and therapeutics, 15 2
Christian Wagner, P. Zhao, Yuzhuo Pan, Vicky Hsu, J. Grillo, Shiew-Mei Huang, V. Sinha (2015)
Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPKCPT: Pharmacometrics & Systems Pharmacology, 4
Jiansong Yang, M. Jamei, K. Yeo, G. Tucker, A. Rostami-Hodjegan (2007)
Prediction of intestinal first-pass drug metabolism.Current drug metabolism, 8 7
S. Wildt, G. Kearns, W. Hop, D. Murry, S. Abdel‐Rahman, J. Anker (2001)
Pharmacokinetics and metabolism of intravenous midazolam in preterm infantsClinical Pharmacology & Therapeutics, 70
T. Rodgers, M. Rowland (2006)
Physiologically based pharmacokinetic modelling 2: predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions.Journal of pharmaceutical sciences, 95 6
E. Luzón, K. Blake, S. Cole, A. Nordmark, C. Versantvoort, E. Berglund (2017)
Physiologically based pharmacokinetic modeling in regulatory decision‐making at the European Medicines AgencyClinical Pharmacology & Therapeutics, 102
D. Hirt, B. Overmeire, J. Treluyer, J. Langhendries, A. Marguglio, M. Eisinger, P. Schepens, S. Urien (2008)
An optimized ibuprofen dosing scheme for preterm neonates with patent ductus arteriosus, based on a population pharmacokinetic and pharmacodynamic study.British journal of clinical pharmacology, 65 5
W. Meuldermans, R. Hurkmans, J. Heykants (1982)
Plasma protein binding and distribution of fentanyl, sufentanil, alfentanil and lofentanil in blood.Archives internationales de pharmacodynamie et de therapie, 257 1
Willem Meuldermans, R. Woestenborghs, Henk Noorduin, Frederic Camu, A. Steenberge, J. Heykants (2004)
Protein binding of the analgesics alfentanil and sufentanil in maternal and neonatal plasmaEuropean Journal of Clinical Pharmacology, 30
R. Hines (2007)
Ontogeny of human hepatic cytochromes P450Journal of Biochemical and Molecular Toxicology, 21
W. Shin, M. Lee, M. Lee, N. Kim (1992)
Pharmacokinetics of drugs in blood. VII: Unusual distribution and blood storage effect of vancomycin.Biopharmaceutics & drug disposition, 13 4
L. Berezhkovskiy (2004)
Volume of distribution at steady state for a linear pharmacokinetic system with peripheral elimination.Journal of pharmaceutical sciences, 93 6
B. Williams, J. Ransom, P. Gal, R. Carlos, M. Smith, S. Schall (1997)
Gentamicin pharmacokinetics in neonates with patent ductus arteriosus.Critical care medicine, 25 2
J. Brussee, Huixin Yu, E. Krekels, B. Roos, M. Brill, J. Anker, A. Rostami-Hodjegan, S. Wildt, C. Knibbe (2018)
First‐Pass CYP3A‐Mediated Metabolism of Midazolam in the Gut Wall and Liver in Preterm NeonatesCPT: Pharmacometrics & Systems Pharmacology, 7
P. Madadi, C. Ross, Hayden, B. Carleton, A. Gaedigk, J. Leeder, Gideon Koren (2009)
Pharmacogenetics of Neonatal Opioid Toxicity Following Maternal Use of Codeine During Breastfeeding: A Case–Control StudyClinical Pharmacology & Therapeutics, 85
M. Reed, R. Kliegman, J. Weiner, Marian Huang, T. Yamashita, J. Blumer (1987)
The Clinical Pharmacology of Vancomycin in Seriously Ill Preterm InfantsPediatric Research, 22
D. Touw, J. Proost, R. Lafeber, H. Stevens, M. Weissenbruch (2001)
Gentamicin pharmacokinetics in preterm infants with a patent and a closed ductus arteriosusPharmacy World and Science, 23
N. Marlow, A. Weindling, A. Peer, J. Heykants (1990)
Alfentanil pharmacokinetics in preterm infants.Archives of Disease in Childhood, 65
T. Johnson, A. Rostami-Hodjegan, G. Tucker (2006)
Prediction of the Clearance of Eleven Drugs and Associated Variability in Neonates, Infants and ChildrenClinical Pharmacokinetics, 45
M. Shebley, P. Sandhu, Arian Riedmaier, M. Jamei, Rangaraj Narayanan, Aarti Patel, S. Peters, V. Reddy, M. Zheng, L. Zwart, M. Bénéton, F. Bouzom, Jun Chen, Yuan Chen, Y. Cleary, C. Collins, G. Dickinson, N. Djebli, H. Einolf, I. Gardner, F. Huth, F. Kazmi, Feras Khalil, Jing Lin, A. Odinecs, C. Patel, H. Rong, E. Schuck, Pradeep Sharma, Shufang Wu, Yang Xu, S. Yamazaki, Kenta Yoshida, M. Rowland (2018)
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium PerspectiveClinical Pharmacology and Therapeutics, 104
B. Overmeire, D. Touw, P. Schepens, G. Kearns, J. Anker (2001)
Ibuprofen pharmacokinetics in preterm infants with patent ductus arteriosusClinical Pharmacology & Therapeutics, 70
R. Labroo, E. Kharasch (1994)
Gas chromatographic-mass spectrometric analysis of alfentanil metabolites. Application to human liver microsomal alfentanil biotransformation.Journal of chromatography. B, Biomedical applications, 660 1
M. Rocha, A. Almeida, E. Afonso, V. Martins, J. Santos, F. Leitão, A. Falcão (2000)
The Kinetic Profile of Gentamicin in Premature NeonatesJournal of Pharmacy and Pharmacology, 52
Hugo Kupferschmidt, H. Ha, W. Ziegler, Peter Meier, S. Krähenbühl (1995)
Interaction between grapefruit juice and midazolam in humansClinical Pharmacology & Therapeutics, 58
F. Salem, T. Johnson, K. Abduljalil, G. Tucker, A. Rostami-Hodjegan (2014)
A Re-evaluation and Validation of Ontogeny Functions for Cytochrome P450 1A2 and 3A4 Based on In Vivo DataClinical Pharmacokinetics, 53
B. Friis‐Hansen (1961)
Body water compartments in children: changes during growth and related changes in body composition.Pediatrics, 28
K. Ito, Y. Niida, J. Sato, E. Owada, Keiji Ito, M. Umetsu (1994)
Pharmacokinetics of mefenamic acid in preterm infants with patent ductus arteriosusPediatrics International, 36
S. Bower, C. Hull (1982)
Comparative pharmacokinetics of fentanyl and alfentanil.British journal of anaesthesia, 54 8
E. Nielsen, M. Sandström, P. Honoré, U. Ewald, L. Friberg (2009)
Developmental Pharmacokinetics of Gentamicin in Preterm and Term NeonatesClinical Pharmacokinetics, 48
K. Claassen, K. Thelen, K. Coboeken, Thomas Gaub, J. Lippert, K. Allegaert, S. Willmann (2015)
Development of a Physiologically-Based Pharmacokinetic Model for Preterm Neonates: Evaluation with In Vivo Data.Current pharmaceutical design, 21 39
R. Cock, K. Allegaert, M. Schreuder, Catherine Sherwin, M. Hoog, J. Anker, M. Danhof, C. Knibbe (2012)
Maturation of the Glomerular Filtration Rate in Neonates, as Reflected by Amikacin ClearanceClinical Pharmacokinetics, 51
Peter Gal, J. Ransom, Richard Weaver, S. Schall, Lance Wyble, R. Carlos, Y. Brown (1991)
Indomethacin pharmacokinetics in neonates: the value of volume of distribution as a marker of permanent patent ductus arteriosus closure.Therapeutic drug monitoring, 13 1
C. McPherson, Matthew Haslam, R. Pineda, C. Rogers, J. Neil, T. Inder (2015)
Brain Injury and Development in Preterm Infants Exposed to FentanylAnnals of Pharmacotherapy, 49
E. Kharasch, C. Hoffer, D. Whittington, A. Walker, P. Bedynek (2009)
Methadone Pharmacokinetics Are Independent of Cytochrome P4503A (CYP3A) Activity and Gastrointestinal Drug Transport: Insights from Methadone Interactions with Ritonavir/IndinavirAnesthesiology, 110
E. Kharasch, A. Walker, N. Isoherranen, C. Hoffer, P. Sheffels, Kenneth Thummel, D. Whittington, D. Ensign (2007)
Influence of CYP3A5 Genotype on the Pharmacokinetics and Pharmacodynamics of the Cytochrome P4503A Probes Alfentanil and MidazolamClinical Pharmacology & Therapeutics, 82
C. Vyhlidal, Robin Pearce, R. Gaedigk, J. Calamia, Diana Shuster, Kenneth Thummel, J. Leeder (2015)
Variability in Expression of CYP3A5 in Human Fetal LiverDrug Metabolism and Disposition, 43
EI Nielsen, M Sandstrom, PH Honore, U Ewald, LE Friberg (2009)
Developmental pharmacokinetics of gentamicin in preterm and term neonates: population modelling of a prospective studyClin Pharmacokinet, 48
É. Jacqz-Aigrain, P. Burtin, P. Daoud, L. Desplanques, F. Beaufils (1994)
Placebo-controlled trial of midazolam sedation in mechanically ventilated newborn babiesThe Lancet, 344
(2011)
Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution
M. Reed, W. Asbury, Edress Darsey, W. Rose, J. Murphy, D. Buffington, C. Capers (1993)
Vancomycin Pharmacokinetics in Neonates and Infants: A Retrospective EvaluationAnnals of Pharmacotherapy, 27
R. Ward, D. Benjamin, J. Barrett, K. Allegaert, R. Portman, J. Davis, M. Turner (2017)
Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonatesPediatric Research, 81
Daniel Gonzalez, P. Delmore, Barry Bloom, C. Cotten, Brenda Poindexter, Elisabeth McGowan, K. Shattuck, Kathleen Bradford, P. Smith, M. Cohen-Wolkowiez, Maurine Morris, Wanrong Yin, Daniel Benjamin, M. Laughon (2016)
Clindamycin Pharmacokinetics and Safety in Preterm and Term InfantsAntimicrobial Agents and Chemotherapy, 60
L. Mather (1983)
Clinical Pharmacokinetics of Fentanyl and its Newer DerivativesClinical Pharmacokinetics, 8
Carol Dickson, M. Schwartzman, J. Bertino (1986)
Factors affecting aminoglycoside disposition: Effects of circadian rhythm and dietary protein intake on gentamicin pharmacokineticsClinical Pharmacology & Therapeutics, 39
M. Lee, M. Chen, S. Huang, W. Chiou (1981)
Pharmacokinetics of drugs in blood. I. Unusual distribution of gentamicin.Biopharmaceutics & drug disposition, 2 1
D. Lacroix, D. Lacroix, M. Sonnier, M. Sonnier, A. Moncion, G. Chéron, T. Cresteil, T. Cresteil (1997)
Expression of CYP3A in the human liver--evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth.European journal of biochemistry, 247 2
A. Scierka, Peter Davis, Anthony Killian, Richard Stiller, D. Cook, Robert Guthrie (1989)
Pharmacokinetics of alfentanil in newborn premature infants and older children.Developmental pharmacology and therapeutics, 13 1
Prakesh Shah1, Michael Dunn1, Shoo Lee1, Alexander Allen2, Nalini Singhal3 (2010)
Early Opioid Infusion and Neonatal Outcomes in Preterm Neonates ≤28 Weeks' GestationAm J Perinatol, 28
E. Deininger, K. Oltmanns, P. Wellhoener, B. Fruehwald-Schultes, W. Kern, Bettina Heuer, P. Dominiak, J. Born, H. Fehm, A. Peters (2001)
Losartan attenuates symptomatic and hormonal responses to hypoglycemia in humansClinical Pharmacology & Therapeutics, 70
E. Capparelli, Fames Lane, G. Romanowski, Edward McFeely, W. Murray, Paula Sousa, C. Kildoo, J. Connor (2001)
The Influences of Renal Function and Maturation on Vancomycin Elimination in Newborns and InfantsThe Journal of Clinical Pharmacology, 41
K Ito, Y Niida, J Sato, E Owada, K Ito, M Umetsu (1994)
Pharmacokinetics of mefenamic acid in preterm infants with patent ductus arteriosusActa Paediatr Jpn, 36
A. Girardi, S. Galletti, E. Raschi, A. Koci, E. Poluzzi, G. Faldella, F. Ponti (2017)
Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unitItalian Journal of Pediatrics, 43
scien tific -guide line/conce pt-paper -need-revis ionguide line-inves tigat ion-medic inal-produ cts-term-prete rm-neona te-revis ion_en
M. Za'abi, T. Donovan, D. Tudehope, P. Woodgate, L. Collie, B. Charles (2007)
Orogastric and Intravenous Indomethacin Administration to Very Premature Neonates With Patent Ductus Arteriosus: Population Pharmacokinetics, Absolute Bioavailability, and Treatment OutcomeTherapeutic Drug Monitoring, 29
S. Wildt, G. Kearns, Wim Hop, Daryl Murry, Susan Abdel-Rahman, Susan Abdel-Rahman, J. Anker, J. Anker (2002)
Pharmacokinetics and metabolism of oral midazolam in preterm infants.British journal of clinical pharmacology, 53 4
D. Wiest, B. Ohning, S. Garner (1991)
The Disposition of Alfentanil in Neonates with Respiratory DistressPharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 11
Kanwaljeet Anand, Brian Anderson, Nicholas Holford, R. Hall, Thomas Young, B. Shephard, Nirmala Desai, B. Barton (2008)
Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: secondary results from the NEOPAIN trial.British journal of anaesthesia, 101 5
J. Momper, E. Capparelli, K. Wade, A. Kantak, R. Dhanireddy, J. Cummings, J. Nedrelow, M. Hudak, Gratias Mundakel, G. Natarajan, Jamie Gao, M. Laughon, P. Smith, D. Benjamin (2016)
Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 GramsAntimicrobial Agents and Chemotherapy, 60
(2014)
Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate
P. Lietman, U. Schaad, G. Mccracken, J. Nelson (1980)
Clinical pharmacology and efficacy of vancomycin in pediatric patients.The Journal of pediatrics, 96 1
Ian Templeton, N. Jones, L. Musib (2018)
Pediatric Dose Selection and Utility of PBPK in Determining DoseThe AAPS Journal, 20
L. Ku, P. Smith (2015)
Dosing in neonates: special considerations in physiology and trial designPediatric Research, 77
W. Meuldermans, A. Peer, J. Hendrickx, R. Woestenborghs, W. Lauwers, J. Heykants, G. Bussche, Herbert Craeyvelt, P. Aa (1988)
Alfentanil Pharmacokinetics and Metabolism in HumansAnesthesiology, 69
M. Leider (1985)
Goodman & Gilman's The Pharmacological Basis of Therapeutics
J. Aranda, A. Varvarigou, K. Beharry, R. Bansal, C. Bardin, H. Modanlou, A. Papageorgiou, S. Chemtob (1997)
Pharmacokinetics and protein binding of intravenous ibuprofen in the premature newborn infantActa Pædiatrica, 86
J Schuttler, H Stoeckel (1982)
Clinical pharmacokinetics of alfentanyl (author’s transl) [in German]Anaesthesist, 31
R. Michelet, J. Bocxlaer, K. Allegaert, A. Vermeulen (2018)
The use of PBPK modeling across the pediatric age range using propofol as a caseJournal of Pharmacokinetics and Pharmacodynamics, 45
K. Rainsford (2009)
Ibuprofen: pharmacology, efficacy and safetyInflammopharmacology, 17
(2014)
Guidance for Industry; General Clinical Pharmacology Considerations for Pediatric Studies for drugs and Biological Products
M. Kees, S. Wicha, A. Seefeld, F. Kees, C. Kloft (2014)
Unbound fraction of vancomycin in intensive care unit patientsThe Journal of Clinical Pharmacology, 54
A. Edginton, W. Schmitt, B. Voith, S. Willmann (2006)
A Mechanistic Approach for the Scaling of Clearance in ChildrenClinical Pharmacokinetics, 45
S. Leroux, Wei Zhao, P. Bétrémieux, P. Pladys, E. Saliba, É. Jacqz-Aigrain (2015)
Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national surveyArchives of Disease in Childhood, 100
L. Goodman, A. Gilman (1976)
The Pharmacological Basis of TherapeuticsOptometry and Vision Science, 53
H. Allonen, G. Ziegler, U. Klotz (1981)
Midazolam kineticsClinical Pharmacology & Therapeutics, 30
Gwendolyn Kuehl, J. Lampe, J. Potter, J. Bigler (2005)
GLUCURONIDATION OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: IDENTIFYING THE ENZYMES RESPONSIBLE IN HUMAN LIVER MICROSOMESDrug Metabolism and Disposition, 33
K. Watterberg, H. Kelly, J. Johnson, M. Aldrich, P. Angelus (1987)
Effect of patent ductus arteriosus on gentamicin pharmacokinetics in very low birth weight (less than 1,500 g) babies.Developmental pharmacology and therapeutics, 10 2
BackgroundPreterm neonates are usually not part of a traditional drug development programme, however they are frequently administered medicines. Developing modelling and simulation tools, such as physiologically based pharmacokinetic (PBPK) models that incorporate developmental physiology and maturation of drug metabolism, can be used to predict drug exposure in this group of patients, and may help to optimize drug dose adjustment.ObjectiveThe aim of this study was to assess and verify the predictability of a preterm PBPK model using compounds that undergo diverse renal and/or hepatic clearance based on the knowledge of their disposition in adults.MethodsA PBPK model was developed in the Simcyp Simulator V17 to predict the pharmacokinetics (PK) of drugs in preterm neonates. Drug parameters for alfentanil, midazolam, caffeine, ibuprofen, gentamicin and vancomycin were collated from the literature. Predicted PK parameters and profiles were compared against the observed data.ResultsThe preterm PBPK model predicted the PK changes of the six compounds using ontogeny functions for cytochrome P450 (CYP) 1A2, CYP2C9 and CYP3A4 after oral and intravenous administrations. For gentamicin and vancomycin, the maturation of renal function was able to predict the exposure of these two compounds after intravenous administration. All PK parameter predictions were within a twofold error criteria.ConclusionWhile the developed preterm model for the prediction of PK behaviour in preterm patients is not intended to replace clinical studies, it can potentially help with deciding on first-time dosing in this population and study design in the absence of clinical data.
Clinical Pharmacokinetics – Springer Journals
Published: Apr 5, 2020
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