Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 50, 2020 - Issue 11
182
Views
3
CrossRef citations to date
0
Altmetric
General Xenobiochemistry

First dose in neonates: pharmacokinetic bridging study from juvenile mice to neonates for drugs metabolized by CYP3A

, , , , , , , , , , , & ORCID Icon show all
Pages 1275-1284 | Received 12 Mar 2020, Accepted 09 May 2020, Published online: 25 May 2020

References

  • Aarnes TK, Fry PR, Hubbell JA, et al. (2013). Pharmacokinetics and pharmacodynamics of midazolam after intravenous and intramuscular administration in alpacas. Am J Vet Res 74:294–9.
  • Abduljalil K, Pan X, Pansari A, et al. (2020). Preterm physiologically based pharmacokinetic model. Part II: applications of the model to predict drug pharmacokinetics in the preterm population. Clin Pharmacokinet 59:501–18.
  • Anderson BJ, Larsson P. (2011). A maturation model for midazolam clearance. Paediatr Anaesth 21:302–8.
  • Bell DM, Richards G, Dhillon S, et al. (1991). A comparative pharmacokinetic study of intravenous and intramuscular midazolam in patients with epilepsy. Epilepsy Res 10:183–90.
  • Bell MJ, Shackelford P, Smith R, et al. (1984). Pharmacokinetics of clindamycin phosphate in the first year of life. J Pediatr 105:482–6.
  • Bouazza N, Pestre V, Jullien V, et al. (2012). Population pharmacokinetics of clindamycin orally and intravenously administered in patients with osteomyelitis. Br J Clin Pharmacol 74:971–7.
  • Brendel K, Comets E, Laffont C, et al. (2006). Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 23:2036–49.
  • Burtin P, Jacqz-Aigrain E, Girard P, et al. (1994). Population pharmacokinetics of midazolam in neonates. Clin Pharmacol Ther 56:615–25.
  • Cella M, Gorter de Vries F, Burger D, et al. (2010b). A model-based approach to dose selection in early pediatric development. Clin Pharmacol Ther 87:294–302.
  • Cella M, Knibbe C, Danhof M, et al. (2010a). What is the right dose for children? Br J Clin Pharmacol 70:597–603.
  • Comets E, Brendel K, Mentré F. (2008). Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the NPDE add-on package for R. Comput Methods Programs Biomed 90:154–66.
  • Court MH, Greenblatt DJ. (1992). Pharmacokinetics and preliminary observations of behavioral changes following administration of midazolam to dogs. J Vet Pharmacol Ther 15:343–50.
  • Crevoisier C, Eckert M, Heizmann P, et al. (1981). [Relation between the clinical effect and the pharmacokinetics of midazolam following i.m. and i.v. administration/2nd comm.: Pharmacokinetical aspects (author’s transl)]. Arzneimittelforschung 31:2211–5.
  • Cui JY, Renaud HJ, Klaassen CD. (2012). Ontogeny of novel cytochrome P450 gene isoforms during postnatal liver maturation in mice. Drug Metab Dispos 40:1226–37.
  • De Cock RF, Piana C, Krekels EH, et al. (2011). The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol 67:5–16.
  • De Wildt SN, Kearns GL, Sie SD, et al. (2003). Pharmacodynamics of intravenous and oral midazolam in preterm infants. Clin Drug Invest 23:27–38.
  • Gonzalez D, Delmore P, Bloom BT, et al. (2016). Clindamycin pharmacokinetics and safety in preterm and term infants. Antimicrob Agents Chemother 60:2888–94.
  • Gonzalez D, Melloni C, Yogev R, et al.; Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. (2014). Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther 96:429–37.
  • Harte GJ, Gray PH, Lee TC, et al. (1997). Haemodynamic responses and population pharmacokinetics of midazolam following administration to ventilated, preterm neonates. J Paediatr Child Health 33:335–8.
  • Hines RN. (2007). Ontogeny of human hepatic cytochromes P450. J Biochem Mol Toxicol 21:169–75.
  • Hooker AC, Staatz CE, Karlsson MO. (2007). Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res 24:2187–97.
  • Hung OR, Dyck JB, V Arvel J, et al. (1996). Comparative absorption kinetics of intramuscular midazolam and diazepam. Can J Anaesth 43:450–5.
  • Jacqz-Aigrain E, Daoud P, Burtin P, et al. (1992). Pharmacokinetics of midazolam during continuous infusion in critically ill neonates. Eur J Clin Pharmacol 42:329–32.
  • Kang HE, Lee MG. (2011). Approaches for predicting human pharmacokinetics using interspecies pharmacokinetic scaling. Arch Pharm Res 34:1779–88.
  • Kearns GL, Abdel-Rahman SM, Alander SW, et al. (2003). Developmental pharmacology – drug disposition, action, and therapy in infants and children. N Engl J Med 349:1157–67.
  • Klassen TP, Hartling L, Craig JC, et al. (2008). Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med 5:e172.
  • Koren G, Zarfin Y, Maresky D, et al. (1986). Pharmacokinetics of intravenous clindamycin in newborn infants. Pediatr Pharmacol (New York) 5:287–92.
  • Lacroix D, Sonnier M, Moncion A, et al. (1997). Expression of CYP3A in the human liver-evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 247:625–34.
  • Larouche CB, Johnson R, Beaudry F, et al. (2019). Pharmacokinetics of midazolam and its major metabolite 1-hydroxymidazolam in the ball python (Python regius) after intracardiac and intramuscular administrations. J Vet Pharmacol Ther 42:722–31.
  • Lavy E, Ziv G, Shem-Tov M, et al. (1999). Pharmacokinetics of clindamycin HCl administered intravenously, intramuscularly and subcutaneously to dogs. J Vet Pharmacol Ther 22:261–5.
  • Lee TC, Charles BG, Harte GJ, et al. (1999). Population pharmacokinetic modeling in very premature infants receiving midazolam during mechanical ventilation: midazolam neonatal pharmacokinetics. Anesthesiology 90:451–7.
  • Lindbom L, Ribbing J, Jonsson EN. (2004). Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 75:85–94.
  • Mahmood I, Ahmad T, Mansoor N, et al. (2017). Prediction of clearance in neonates and infants (≤3 months of age) for drugs that are glucuronidated: a comparative study between allometric scaling and physiologically based pharmacokinetic modeling. J Clin Pharmacol 57:476–83.
  • Mahmood I, Balian JD. (1996). Interspecies scaling: predicting clearance of drugs in humans. Three different approaches. Xenobiotica 26:887–95.
  • Mahmood I, Cheng A, Brauer E, et al. (2016). Prediction of antimalarial drug clearance in children: a comparison of three different interspecies scaling methods. Eur J Drug Metab Pharmacokinet 41:767–75.
  • Mahmood I, Tegenge MA. (2019). A comparative study between allometric scaling and physiologically based pharmacokinetic modeling for the prediction of drug clearance from neonates to adolescents. J Clin Pharmacol 59:189–97.
  • Mahmood I. (2007). Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development. Adv Drug Deliv Rev 59:1177–92.
  • Mahmood I. (2009). Pharmacokinetic allometric scaling of antibodies: application to the first-in-human dose estimation. J Pharm Sci 98:3850–61.
  • Mahmood I. (2010). Interspecies scaling for the prediction of drug clearance in children: application of maximum lifespan potential and an empirical correction factor. Clin Pharmacokinet 49:479–92.
  • Mahmood I. (2020). Extrapolation of drug clearance in children ≤ 2 years of age from empirical models using data from children (> 2 years) and adults. Drugs R D 20:1–10.
  • Mansoor N, Ahmad T, Alam Khan R, et al. (2016). Prediction of clearance and dose of midazolam in preterm and term neonates: a comparative study between allometric scaling and physiologically based pharmacokinetic modeling. Am J Ther 0:1–6.
  • Nakagaki BN, Mafra K, de Carvalho É, et al. (2018). Immune and metabolic shifts during neonatal development reprogram liver identity and function. J Hepatol 69:1294–307.
  • O’Hara K, Wright IMR, Schneider JJ, et al. (2015). Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future. Br J Clin Pharmacol 80:1281–8.
  • Pacifici GM. (2014). Clinical pharmacology of midazolam in neonates and children: effect of disease – a review. Int J Pediatr 2014: 309342.
  • Payne K, Mattheyse FJ, Liebenberg D, et al. (1989). The pharmacokinetics of midazolam in paediatric patients. Eur J Clin Pharmacol 37:267–72.
  • Pecking M, Montestruc F, Marquet P, et al. (2002). Absolute bioavailability of midazolam after subcutaneous administration to healthy volunteers. Br J Clin Pharmacol 54:357–62.
  • Rhodin MM, Anderson BJ, Peters AM, et al. (2009). Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol 24:67–76.
  • Sacher GA. (1959). Relation of lifespan to brain weight and body weight in mammals. In: Wolstenholme GEW, O’Connor M, eds. Ciba Foundation Symposium – The lifespan of animals (colloquia on ageing). London: J. & A. Churchill, 115–141.
  • Simon BT, Scallan EM, O O, et al. (2017). Pharmacokinetics and pharmacodynamics of midazolam following intravenous and intramuscular administration to sheep. Am J Vet Res 78:539–549.
  • Sinha I, Jones L, Smyth RL, et al. (2008). A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med 5:e96.
  • Sinha VK, De Buck SS, Fenu LA, et al. (2008). Predicting oral clearance in humans: how close can we get with allometry?. Clin Pharmacokinet 47:35–45.
  • Sinha VK, Vaarties K, De Buck SS, et al. (2011). Towards a better prediction of peak concentration, volume of distribution and half-life after oral drug administration in man, using allometry. Clin Pharmacokinet 50:307–18.
  • Strougo A, Yassen A, Monnereau C, et al. (2014). 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 Pharmaco 54:1006–15.
  • Suresh PS, Jairam RK, Chandrasekhar DV, et al. (2018). Prediction of human pharmacokinetics of ulixertinib, a novel ERK1/2 inhibitor from mice, rats, and dogs pharmacokinetics. Eur J Drug Metab Pharmacokinet 43:453–460.
  • Völler S, Flint RB, Beggah F, et al. (2019). Recently registered midazolam doses for preterm neonates do not lead to equal exposure: a population pharmacokinetic model. J Clin Pharmaco 59:1300–1308.
  • Wu Q, Peters SA. (2019). A retrospective evaluation of allometry, population pharmacokinetics, and physiologically-based pharmacokinetics for pediatric dosing using clearance as a surrogate. CPT Pharmacometrics Syst Pharmacol 8:220–229.
  • Wynalda MA, Hutzler JM, Koets MD, et al. (2003). In vitro metabolism of clindamycin in human liver and intestinal microsomes. Drug Metab Dispos 31:878–87.
  • Yun YE, Edginton AN. (2019). Model qualification of the PK-Sim® pediatric module for pediatric exposure assessment of CYP450 metabolized compounds. J Toxicol Environ Health Part A 82:789–814.
  • Zhao W, Le Guellec C, Benjamin DK, Jr, et al. (2014). First dose in neonates: are juvenile mice, adults and in vitro-in silico data predictive of neonatal pharmacokinetics of fluconazole. Clin Pharmacokinet 53:1005–18.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.