Prediction of drug clearance in children: a review of different methodologies

Bibliography

• Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology: drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349:1157-67
   PubMed Web of Science ®Google Scholar
• Mahmood I. Developmental pharmacology: impact on pharmacokinetic and pharmacodynamics of drugs. In: Pediatric pharmacology and pharmacokinetics. Pine House Publishers; Rockville, MD: 2008. p. 68-107
   Google Scholar
• Mahmood I. Dose selection in children: allometry and other methods. In: Pediatric pharmacology and pharmacokinetics. Pine House Publishers; Rockville, MD: 2008. p. 184-216
   Google Scholar
• Mahmood I. Dose selection in children. In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 151-60
   Google Scholar
• Gibaldi M. Gastrointestinal absorption: physicochemical considerations. In: Biopharmaceutics and clinical pharmacokinetics. 3rd edition. Lea and Febiger; Philadelphia: 1984. p. 44-63
   Google Scholar
• Huang NN, High RH. Comparison of serum levels following the administration of oral and parenteral preparations of penicillin to infants and children of various age groups. J Pediatr 1953;42:657-68
   PubMed Web of Science ®Google Scholar
• Rutter N. Percutaneous drug absorption in the newborn: hazards and uses. Clin Perinatol 1987;14:911-30
   PubMed Web of Science ®Google Scholar
• Friis-Hansen B. Body water compartments in children: changes during growth and related changes in body composition. Pediatrics 1961;28:169-81
   PubMed Web of Science ®Google Scholar
• McNammara PJ, Alcorn J. Protein binding predictions in infants. AAPS PharmSci 2002;4:1-8
   Google Scholar
• Blanco JG, Harrison PL, Evans WE, et al. Human cytochrome P450 maximal activities in pediatric versus adult liver. Drug Metab Dispos 2000;28:379-82
   PubMed Web of Science ®Google Scholar
• Lacroix D, Sonnier M, Moncion A, et al. Expression of CYP3A in the human liver – evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 1997;247:625-34
   PubMedGoogle Scholar
• Koukouritaki SB, Manro JR, Marsh SA, et al. Developmental expression of human hepatic CYP2C9 and CYP2C19. J Pharmacol Exp Ther 2004;308(3):965-74
   PubMed Web of Science ®Google Scholar
• Daly AK, Brockmoller J, Broly F, et al. Nomenclature for human CYP2D6 alleles. Pharmacogenetics 1996;6:193-201
   PubMedGoogle Scholar
• Sonnier M, Cresteil T. Delayed ontogenesis of CYP1A2 in the human liver. Eur J Biochem 1998;251:893-8
   PubMedGoogle Scholar
• Pacifici GM, Franchi M, Colizzi C, et al. Glutathione S-transferase in humans: development and tissue distribution. Arch Toxicol 1988;6:265-9
   Google Scholar
• McRorie TI, Lynn AM, Nespeca MK, et al. The maturation of morphine clearance and metabolism. Am J Dis Child 1992;146:972-6
   PubMedGoogle Scholar
• Loebstein R, Koren G. Clinical pharmacology and therapeutic drug monitoring in neonates and children. Pediatr Rev 1998;19:423-8
   PubMedGoogle Scholar
• Arant BSJr. Developmental patterns of renal functional maturation compared in the human neonate. J Pediatr 1978;92:705-12
   PubMed Web of Science ®Google Scholar
• Jones DP, Chesney RW. Development of tubular function. Clin Perinatol 1992;19:33-57
   PubMed Web of Science ®Google Scholar
• Chappell WR, Mordenti J. Extrapolation of toxicological and pharmacological data from animals to humans. Adv Drug Res 1991;20:1-116
   Google Scholar
• Boxenbaum H. Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 1984;15:1071-121
   PubMed Web of Science ®Google Scholar
• Mahmood I. Introduction to allometry. In: Interspecies pharmacokinetic scaling: principles and application of allometric scaling. Pine House Publishers; Rockville, MD 2005: p. 23-38
   Google Scholar
• Mahmood I. Prediction of drug clearance in children from adult clearance: allometric scaling versus exponent 0.75. In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 41-55
   Google Scholar
• Mahmood I. Prediction of drug clearance in children (≤ 5 years) by Boxenbaum Coefficient Methods. In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 64-77
   Google Scholar
• Peeters MY, Allegaert K, Blussé van Oud-Alblas HJ, et al. Prediction of propofol clearance in children from an allometric model developed in rats, children and adults versus a 0.75 fixed-exponent allometric model. Clin Pharmacokinet 2010;49:269-75
   PubMed Web of Science ®Google Scholar
• Björkman S. Prediction of cytochrome p450-mediated hepatic drug clearance in neonates, infants and children: how accurate are available scaling methods? Clin Pharmacokinet 2006;45:1-11
   PubMed Web of Science ®Google Scholar
• Edginton AN, Shah B, Sevestre M, et al. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of 6 years. Clin Pharmacokinet 2013;52:693-703
   PubMed Web of Science ®Google Scholar
• Momper JD, Mulugeta Y, Green DJ, et al. Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007. JAMA Pediatr 2013;167:926-32
   PubMed Web of Science ®Google Scholar
• Kleiber M. Body size and metabolism. Hilgardia 1932;6:315
   Google Scholar
• Kleiber M. Body size and metabolic rate. Physiol Rev 1947;4:511-41
   Google Scholar
• Hayssen V, Lacy RC. Basal metabolic rates in mammals: toxonomic differences in the allometry of BMR and body mass. Comp Biochem Physiol A Comp Physiol 1985;81A:741-54
   Google Scholar
• West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science 1997;276:122-6
   PubMed Web of Science ®Google Scholar
• Kozłowski J, Konarzewski M. Is West, Brown and Enquist’s model of allometric scaling mathematically correct and biologically relevant? Funct Ecol 2004;18:283-9
   Web of Science ®Google Scholar
• Kozłowski J, Konarzewski M. West, Brown and Enquist’s model of allometric scaling again: the same questions remain. Funct Ecol 2005;19:739-43
   Web of Science ®Google Scholar
• Painter PR. The fractal geometry of nutrient exchange surfaces does not provide an explanation for 3/4-power metabolic scaling. Theor Biol Med Model 2005;2:30
   PubMed Web of Science ®Google Scholar
• Petit G, Anfodillo T. Plant physiology in theory and practice: an analysis of the WBE model for vascular plants. J Theor Biol 2009;259:1-4
   PubMed Web of Science ®Google Scholar
• Glazier DS. Beyond the ‘3/4-power law’: variation in the intra- and interspecific scaling of metabolic rate in animals. Biol Rev Camb Philos Soc 2005;80:611-62
   PubMed Web of Science ®Google Scholar
• White CR, Cassey P, Blackburn TM. Allometric exponents do not support a universal metabolic allometry. Ecology 2007;88:315-23
   PubMed Web of Science ®Google Scholar
• Packard GC, Birchard GF. Traditional allometric analysis fails to provide a valid predictive model for mammalian metabolic rates. J Exp Biol 2008;211(Pt 22):3581-7
   PubMed Web of Science ®Google Scholar
• Mahmood I. Theoretical versus empirical allometry: facts behind theories and application to pharmacokinetics. J Pharm Sci 2010;99:2927-33
   PubMed Web of Science ®Google Scholar
• Mahmood I. Application of fixed exponent 0.75 to the prediction of human drug clearance: an inaccurate and misleading concept. Drug Metabol Drug Interact 2009;24:57-81
   PubMedGoogle Scholar
• West D, West BJ. Physiologic time: a hypothesis. Phys Life Rev 2013;10:210-24
   PubMed Web of Science ®Google Scholar
• Bentley LP, Stegen JC, Savage VM, et al. An empirical assessment of tree branching networks and implications for plant allometric scaling models. Ecol Lett 2013;16:1069-78
   PubMed Web of Science ®Google Scholar
• Mahmood I. Prediction of drug clearance in children: impact of allometric exponents, body weight and age. Ther Drug Monit 2007;29:271-8
   PubMed Web of Science ®Google Scholar
• Mahmood I. Prediction of drug clearance in preterm and term neonates: different exponents for different age groups? In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 88-100
   Google Scholar
• Mahmood I. Allometric exponents and population pharmacokinetics: a single or body weight dependent exponents. In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 88-100
   Google Scholar
• Mahmood I. Prediction of drug clearance in children from adults: a comparison of several allometric methods. Br J Clin Pharmacol 2006;61:545-57
   PubMed Web of Science ®Google Scholar
• Mahmood I. Prediction of drug clearance in children 3 months and younger: an allometric approach. Drug Metabol Drug Interact 2010;25:25-34
   PubMedGoogle Scholar
• Knibbe CA, Zuideveld KP, Aarts LP, et al. Allometric relationships between the pharmacokinetics of propofol in rats, children and adults. Br J Clin Pharmacol 2005;59:705-11
   PubMed Web of Science ®Google Scholar
• Mahmood I. Interspecies scaling for the prediction of drug clearance in children: application of maximum lifespan potential and an empirical correction factor. Clin Pharmacokinet 2010;49:479-92
   PubMed Web of Science ®Google Scholar
• Senarathna SM, Batty KT. Interspecies allometric scaling of antimalarial drugs and potential application to pediatric dosing. Antimicrob Agents Chemother 2014;58:6068-78
   PubMed Web of Science ®Google Scholar
• Strougo A, Yassen A, Monnereau C, et al. Predicting the “First dose in children” of CYP3A-metabolized drugs: evaluation of scaling approaches and insights into the CYP3A7-CYP3A4 switch at young ages. J Clin Pharmacol 2014;54:1006-15
   PubMed Web of Science ®Google Scholar
• Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006;45:931-56
   PubMed Web of Science ®Google Scholar
• Edginton AN, Schmitt W, Voith B, Willmann S. A mechanistic approach for the scaling of clearance in children. Clin Pharmacokinet 2006;45:683-704
   PubMed Web of Science ®Google Scholar
• Lacroix D, Sonnier M, Moncion A, et al. Expression of CYP3A in the human liver-evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 1997;247:625-34
   PubMedGoogle Scholar
• Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J 2005;7:E475-87
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur J Pediatr 2006;165:819-29
   PubMed Web of Science ®Google Scholar
• Cella M, Zhao W, Jacqz-Aigrain E, et al. Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations? Br J Clin Pharmacol 2011;72:454-64
   PubMed Web of Science ®Google Scholar
• Santen G, Horrigan J, Danhof M, Della Pasqua O. From trial and error to trial simulation. Part 2: an appraisal of current beliefs in the design and analysis of clinical trials for antidepressant drugs. Clin Pharmacol Ther 2009;86:255-62
   PubMed Web of Science ®Google Scholar
• Mahmood I. Allometric exponents and population pharmacokinetics: a single or body weight dependent exponents. In: Pharmacokinetic allometric scaling in pediatric drug development. Pine House Publishers; Rockville, MD: 2013. p. 121-37
   Google Scholar
• El-Tahtawy A, Kokki H, Reidenberg BE. Population pharmacokinetics of oxycodone in children 6 months to 7 years old. J Clin Pharmacol 2006;46:433-42
   PubMed Web of Science ®Google Scholar
• Takala A, Kaasalainen V, Seppala T, et al. Pharmacokinetic comparison of intravenous and intranasal administration of oxycodone. Acta Anaesthesiol Scand 1997;41:309-12
   PubMed Web of Science ®Google Scholar
• Booth BP, Rahman A, Dagher R, et al. Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. J Clin Pharmacol 2007;47:101-11
   PubMed Web of Science ®Google Scholar
• Tran H, Petropoulos D, Worth L, et al. Pharmacokinetics and individualized dose adjustment of intravenous busulfan in children with advanced hematologic malignancies undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant 2004;10:805-12
   PubMed Web of Science ®Google Scholar
• Dalle JH, Wall D, Theoret Y, et al. Intravenous busulfan for allogeneic hematopoietic stem cell transplantation in infants: clinical and pharmacokinetic results. Bone Marrow Transplant 2003;32:647-51
   PubMed Web of Science ®Google Scholar
• de Wildt SN, de Hoog M, Vinks AA, et al. Population pharmacokinetics and metabolism of midazolam in pediatric intensive care patients. Crit Care Med 2003;31:1952-8
   PubMed Web of Science ®Google Scholar
• Burtin P, Jacqz-Aigrain E, Girard P, et al. Population pharmacokinetics of midazolam in neonates. Clin Pharmacol Ther 1994;56(6 Pt 1):615-25
   PubMed Web of Science ®Google Scholar
• Jacqz-Aigrain E, Wood C, Robieux I. Pharmacokinetics of midazolam in critically ill neonates. Eur J Clin Pharmacol 1990;39:191-2
   PubMed Web of Science ®Google Scholar
• Kearns GL, Bradley JS, Jacobs RF, et al. Single dose pharmacokinetics of pleconaril in neonates. Pediatric Pharmacology Research Unit Network. Pediatr Infect Dis J 2000;19:833-9
   PubMed Web of Science ®Google Scholar
• Kearns GL, Abdel-Rahman SM, James LP, et al. Single-dose pharmacokinetics of a pleconaril (VP63843) oral solution in children and adolescents. Pediatric Pharmacology Research Unit Network. Antimicrob Agents Chemother 1999;43:634-8
   PubMed Web of Science ®Google Scholar
• Anand KJ, Anderson BJ, Holford NH, NEOPAIN Trial Investigators Group. Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: secondary results from the NEOPAIN trial. Br J Anaesth 2008;101:680-9
   PubMed Web of Science ®Google Scholar
• Anderson BJ. Pediatric models for adult target-controlled infusion pumps. Paediatr Anaesth 2010;20:223-32
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Larsson P. A maturation model for midazolam clearance. Paediatr Anaesth 2011(3):302-8
   PubMed Web of Science ®Google Scholar
• Mahmood I. Evaluation of a morphine maturation model for the prediction of morphine clearance in children: how accurate is the predictive performance of the model? Br J Clin Pharmacol 2011;71:88-94
   PubMed Web of Science ®Google Scholar
• Mahmood I. Evaluation of sigmoidal maturation and allometric models: prediction of propofol clearance in neonates and infants. Am J Ther 2013;20:21-8
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Holford NH. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet 2009;24:25-36
   PubMed Web of Science ®Google Scholar
• Mahmood I. Response to the comments of Professors Anderson & Holford. Br J Clin Pharmacol 2011;72(3):521-3
   Google Scholar
• Wang C, Sadhavisvam S, Krekels EH, et al. Developmental changes in morphine clearance across the entire paediatric age range are best described by a bodyweight-dependent exponent model. Clin Drug Investig 2013;33:523-34
   PubMed Web of Science ®Google Scholar
• Wang C, Allegaert K, Peeters MY, et al. The allometric exponent for scaling clearance varies with age: a study on seven propofol datasets ranging from preterm neonates to adults. Br J Clin Pharmacol 2014;77:149-59
   PubMed Web of Science ®Google Scholar
• Wang C, Peeters MY, Allegaert K, et al. A bodyweight-dependent allometric exponent for scaling clearance across the human life-span. Pharm Res 2012;29:1570-81
   PubMed Web of Science ®Google Scholar
• Bartelink IH, Boelens JJ, Bredius RG, et al. Body weight-dependent pharmacokinetics of busulfan in paediatric haematopoietic stem cell transplantation patients: towards individualized dosing. Clin Pharmacokinet 2012;51:331-45
   PubMed Web of Science ®Google Scholar
• Staschen CM, Mahmood I. A population pharmacokinetic model of remifentanil in pediatric patients using body-weight-dependent allometric exponents. Drug Metabol Drug Interact 2013;28:231-7
   PubMedGoogle Scholar
• Wieser W. A distinction must be made between the ontogeny and the phylogeny of metabolism in order to understand the mass exponent of energy metabolism. Respir Physiol 1984;55:1-9
   PubMedGoogle Scholar
• Mcmohan TA, Bonner JT. Proportions and size. In: On size and life. Scientific American Library; New York: 1983. p. 25-67
   Google Scholar
• Mahmood I, Staschen CM, Goteti K. Prediction of drug clearance in children: an evaluation of the predictive performance of several models. AAPS J 2014;16(6):1334-43
   PubMed Web of Science ®Google Scholar
• Edginton AN, Theil FP, Schmitt W, et al. Whole body physiologically based pharmacokinetic models: their use in clinical drug development. Expert Opin Drug Metab Toxicol 2008;4:1143-52
   PubMed Web of Science ®Google Scholar
• Rowland M, Peck C, Tucker G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 2011;51:45-73
   PubMed Web of Science ®Google Scholar
• Cao Y, Balthasar JP, Jusko WJ. Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodies. J Pharmacokinet Pharmacodyn 2013;40:597-607
   PubMed Web of Science ®Google Scholar
• Cao Y, Jusko WJ. Applications of minimal physiologically-based pharmacokinetic models. J Pharmacokinet Pharmacodyn 2012;39:711-23
   PubMed Web of Science ®Google Scholar
• Jiang XL, Zhao P, Barrett JS, et al. Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children. CPT Pharmacometrics Syst Pharmacol 2013;2:e80
   PubMedGoogle Scholar
• Leong R, Vieira ML, Zhao P, et al. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials. Clin Pharmacol Ther 2012;91:926-31
   PubMed Web of Science ®Google Scholar
• Khalil F, Läer S. Physiologically based pharmacokinetic models in the prediction of oral drug exposure over the entire pediatric age range-sotalol as a model drug. AAPS J 2014;16:226-39
   PubMed Web of Science ®Google Scholar
• Parrott N, Davies B, Hoffmann G, et al. Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants. Clin Pharmacokinet 2011;50:613-23
   PubMed Web of Science ®Google Scholar
• Maharaj AR, Barrett JS, Edginton AN. A workflow example of PBPK modeling to support pediatric research and development: case study with lorazepam. AAPS J 2013;15:455-64
   PubMed Web of Science ®Google Scholar
• Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006;45:931-56
   PubMed Web of Science ®Google Scholar
• Edginton AN, Willmann S. Physiology-based versus allometric scaling of clearance in children: an eliminating process based comparison. Paediatr Perinat Drug Ther 2006;7:146-53
   Google Scholar
• Stephenson T. How children’s responses to drugs differ from adults. Br J Clin Pharmacol 2005;59:670-3
   PubMed Web of Science ®Google Scholar