Potential implications of DMET ontogeny on the disposition of commonly prescribed drugs in neonatal and pediatric intensive care units

References

• Rajabi M. Food Quality Protection Act. In: Wexler PBT-E of T (Third E, editor. Oxford: Academic Press; 2014. p. 637–638. Available from: http://www.sciencedirect.com/science/article/pii/B9780123864543006072.
   Google Scholar
• *Hines RN. Developmental expression of drug metabolizing enzymes: impact on disposition in neonates and young children. Int J Pharm [Internet]. 2013;452(1–2):3–7.
   PubMedGoogle Scholar
• **Laughon MM, Avant D, Tripathi N, et al. Drug labeling and exposure in neonates. JAMA Pediatr. 2014;168(2):130–136.
   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(9):931–956.
   PubMed Web of Science ®Google Scholar
• Sutherland JM. Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol. AMA J Dis Child. 1959;97:761–767.
   PubMedGoogle Scholar
• Weiss CF, Glazko AJ, Weston JK, Chloramphenicol in the newborn infant. N Engl J Med. [Internet]. 1982;22(16):787–794.
   Google Scholar
• De Wildt SN, Kearns GL, Leeder JS, et al. Glucuronidation in humans. Pharmacogenetic and developmental aspects. Clin Pharmacokinet. 1999;36(6):439–452.
   PubMed Web of Science ®Google Scholar
• **Bhatt DK, Mehrotra A, Gaedigk A, et al. Age‐and genotype‐dependent variability in the protein abundance and activity of six major uridine diphosphate‐glucuronosyltransferases in human liver. Clin Pharmacol Ther. 2019;105(1):131–141.
   PubMed Web of Science ®Google Scholar
• **Ladumor MK, Bhatt DK, Gaedigk A, et al. Ontogeny of hepatic sulfotransferases and prediction of age-dependent fractional contribution of sulfation in acetaminophen metabolism. Drug Metab Dispos. 2019;47(8):818–831.
   PubMed Web of Science ®Google Scholar
• Alam SN, Roberts RJ, Fischer LJ. Age-related differences in salicylamide and acetaminophen conjugation in man. J Pediatr [Internet]. 1977;90(1):130–135. cited 2020 May 6. Available from http://www.sciencedirect.com/science/article/pii/S0022347677807877
   PubMed Web of Science ®Google Scholar
• HTM DLC, Costa TX, Martins RR, et al. Use of off-label and unlicensed medicines in neonatal intensive care. PLoS One. 2018;13:1–12.
   Web of Science ®Google Scholar
• McCarver DG, Hines RN. The ontogeny of human drug-metabolizing enzymes: phase II conjugation enzymes and regulatory mechanisms. J Pharmacol Exp Ther. 2002 Feb;300(2):361–6. doi:10.1124/jpet.300.2.361. PMID: 11805192.
   Google Scholar
• Hay M, Thomas DW, Craighead JL, et al. Clinical development success rates for investigational drugs. Nat Biotechnol [Internet]. 2014;32(1):40–51.
   PubMed Web of Science ®Google Scholar
• Harkin T S.3187-112th congress (2011–2012): food and drug administration safety and innovation act. 2012 cited 2020 Jul 29; Available from: https://www.congress.gov/bill/112th-congress/senate-bill/3187
   Google Scholar
• Dodd CJ S.1789-107th congress (2001–2002): best pharmaceuticals for children act. 2002 cited 2020 Jul 29; Available from: https://www.congress.gov/bill/107th-congress/senate-bill/1789
   Google Scholar
• DeWine M S.650-108th congress (2003–2004): pediatric research equity act of 2003. 2003 cited 2020 Jul 29; Available from: https://www.congress.gov/bill/108th-congress/senate-bill/650
   Google Scholar
• Dodd CJ S.830-110th congress (2007–2008): pediatric medical device safety and improvement act of 2007. 2007 cited 2020 Jul 29; Available from: https://www.congress.gov/bill/110th-congress/senate-bill/830
   Google Scholar
• Bhatt DK, Mehrotra A, Gaedigk A, et al. Age- and genotype-dependent variability in the protein abundance and activity of six major uridine diphosphate-glucuronosyltransferases in human liver. Clin Pharmacol Ther. 2019;105(1):131–141.
   PubMed Web of Science ®Google Scholar
• Ladumor MK, Thakur A, Sharma S, et al. A repository of protein abundance data of drug metabolizing enzymes and transporters for applications in physiologically based pharmacokinetic (PBPK) modelling and simulation. Sci Rep. 2019;9(1):1–16.
   PubMedGoogle Scholar
• Salem F, Johnson TN, Barter ZE, et al. Age related changes in fractional elimination pathways for drugs: assessing the impact of variable ontogeny on metabolic drug-drug interactions. J Clin Pharmacol. 2013;53(8):857–865.
   PubMed Web of Science ®Google Scholar
• Blake MJ, Gaedigk A, Pearce RE, et al. Ontogeny of dextromethorphan O‐and N‐demethylation in the first year of life. Clin Pharmacol Ther. 2007;81:510–516.
   PubMed Web of Science ®Google Scholar
• de Wildt SN, Kearns GL, Leeder JS, et al. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet. 1999;37(6):485–505.
   PubMed Web of Science ®Google Scholar
• Gail McCarver D, Hines RN. The ontogeny of human drug-metabolizing enzymes: phase II conjugation enzymes and regulatory mechanisms. J Pharmacol Exp Ther. 2002;300(2):361–366.
   PubMed Web of Science ®Google Scholar
• Saghir SA, Khan SA, McCoy AT. Ontogeny of mammalian metabolizing enzymes in humans and animals used in toxicological studies. Crit Rev Toxicol. 2012 May;42(5):323-57. doi:10.3109/10408444.2012.674100. PMID: 22512665.
   Google Scholar
• Bhatt DK, Basit A, Zhang H, et al. Hepatic abundance and activity of androgen- and drug-metabolizing enzyme UGT2B17 are associated with genotype, age, and sex. Drug Metab Dispos. 2018;46(6):888–896.
   PubMed Web of Science ®Google Scholar
• Hines RN. The ontogeny of drug metabolism enzymes and implications for adverse drug events. Pharmacol Ther. 2008;118(2):250–267.
   PubMed Web of Science ®Google Scholar
• Saravanakumar A, Sadighi A, Ryu R, et al. Physicochemical properties, biotransformation, and transport pathways of established and newly approved medications: a systematic review of the top 200 most prescribed drugs vs. the FDA-approved drugs between 2005 and 2016. Clin Pharmacokinet [Internet]. 2019;58(10):1281–1294.
   PubMed Web of Science ®Google Scholar
• Hu S, Leblanc AF, Gibson AA, et al. Identification of OAT1/OAT3 as contributors to cisplatin toxicity. Clin Transl Sci. 2017;10(5):412–420.
   PubMed Web of Science ®Google Scholar
• Guo Y, Chu X, Parrott NJ, et al. Advancing predictions of tissue and intracellular drug concentrations using in vitro, imaging and physiologically based pharmacokinetic modeling approaches. Clin Pharmacol Ther. 2018;104:865–889.
   PubMed Web of Science ®Google Scholar
• Endres CJ, Moss AM, Ke B, et al. The role of the equilibrative nucleoside transporter 1 (ENT1) in transport and metabolism of ribavirin by human and wild-type or Ent1-/- mouse erythrocytes. J Pharmacol Exp Ther. 2009;329:387–398.
   PubMed Web of Science ®Google Scholar
• Sweeney DE, Vallon V, Rieg T, et al. Functional maturation of drug transporters in the developing, neonatal, and postnatal kidney. Mol Pharmacol. 2011;80(1):147–154.
   PubMed Web of Science ®Google Scholar
• *Prasad B, Gaedigk A, Vrana M, et al. Ontogeny of hepatic drug transporters as quantified by LC-MS/MS proteomics. Clin Pharmacol Ther. 2016;100(4):362–370.
   PubMed Web of Science ®Google Scholar
• **Brouwer KLR, Aleksunes LM, Brandys B, et al. Human ontogeny of drug transporters: review and recommendations of the pediatric transporter working group. Clin Pharmacol Ther. 2015;98(3):266–287.
   PubMed Web of Science ®Google Scholar
• Forrest JAH, Clements JA, Prescott LF. Clinical pharmacokinetics of paracetamol. Clin Pharmacokinet. 1982;7(2):93–107.
   PubMed Web of Science ®Google Scholar
• Wang C, Allegaert K, Tibboel D, et al. Population pharmacokinetics of paracetamol across the human age-range from (pre)term neonates, infants, children to adults. J Clin Pharmacol. 2014;54(6):619–629.
   PubMed Web of Science ®Google Scholar
• Mohamed MHN, Lima JJ, Eberle LV, et al. Effects of gender and race on albuterol pharmacokinetics. Pharmacotherapy. 1999;19(2):157–161.
   PubMed Web of Science ®Google Scholar
• Boulton DW, Fawcett JP. Enantioselective disposition of albuterol in humans. Clin Rev Allergy Immunol. 1996;14(1):115–138.
   PubMed Web of Science ®Google Scholar
• Boulton DW, Fawcett JP. Enantioselective disposition of salbutamol in man following oral and intravenous administration. Br J Clin Pharmacol. 1996;41(1):35–40.
   PubMed Web of Science ®Google Scholar
• Boulton DW, Fawcett JP. The pharmacokinetics of levosalbutamol: what are the clinical implications? Clin Pharmacokinet. 2001;40(1):23–40.
   PubMed Web of Science ®Google Scholar
• Rafailidis PI, Ioannidou EN, Falagas ME. Ampicillin/sulbactam: current status in severe bacterial infections. Drugs. 2007;67(13):1829–1849.
   PubMed Web of Science ®Google Scholar
• Yokoyama Y, Matsumoto K, Yamamoto H, et al. Pharmacokinetics of ampicillin-sulbactam and the renal function-based optimization of dosing regimens for prophylaxis in patients undergoing cardiovascular surgery. J Infect Chemother. 2012;18(6):878–882.
   PubMed Web of Science ®Google Scholar
• Kucers A Kucers’ the use of antibiotics, a clinical review of antibacterial, antifungal, antiparasitic and antiviral drugs. 2012.
   Google Scholar
• Edsbäcker S, Andersson T. Pharmacokinetics of budesonide (EntocortTM EC) capsules for Crohn’s disease. Clin Pharmacokinet. 2004;43:803–821.
   PubMed Web of Science ®Google Scholar
• Blanchard J, Sawers SJA. The absolute bioavailability of caffeine in man. Eur J Clin Pharmacol. 1983;24(1):93–98.
   PubMed Web of Science ®Google Scholar
• Ha HR, Chen J, Krähenbühl S, et al. Biotransformation of caffeine by cDNA-expressed human cytochromes P-450. Eur J Clin Pharmacol. 1996;49(4):309–315.
   PubMed Web of Science ®Google Scholar
• Kaplan GB, Greenblatt DJ, Ehrenberg BL, et al. Dose-dependent pharmacokinetics and psychomotor effects of caffeine in humans. J Clin Pharmacol. 1997;37:693–703.
   PubMed Web of Science ®Google Scholar
• Brachtel D, Richter E. Absolute bioavailability of caffeine from a tablet formulation. J Hepatol. 1992;16(3):385.
   PubMed Web of Science ®Google Scholar
• Rybak M. The pharmacokinetic profile of a new generation of parenteral cephalosporin. Am J Med. 1996;100(6):39S–44S.
   PubMedGoogle Scholar
• Claessens AJ, Risler LJ, Eyal S, et al. CYP2D6 mediates 4-hydroxylation of clonidine in vitro: implication for pregnancy-induced changes in clonidine clearance. Drug Metab Dispos. 2010;38(9):1393–1396.
   PubMed Web of Science ®Google Scholar
• Lowenthal DT, Matzek KM, MacGregor TR. Clinical pharmacokinetics of clonidine. Clin Pharmacokinet. 1988;14(5):287–310.
   PubMed Web of Science ®Google Scholar
• Davies DS, Wing LMH, Reid JL, et al. Pharmacokinetics and concentration-effect relationships of intravenous and oral clonidine. Clin Pharmacol Ther. 1977;21(5):593–601.
   PubMed Web of Science ®Google Scholar
• Spoorenberg SMC, Deneer VHM, Grutters JC, et al. Pharmacokinetics of oral vs . intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014;78(1):78–83.
   PubMed Web of Science ®Google Scholar
• Anttila M, Penttilä J, Helminen A, et al. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003;56(6):691–693.
   PubMed Web of Science ®Google Scholar
• Weerink MAS, Struys MMRF, Hannivoort LN, et al. Clinical pharmacokinetics and pharmacodynamics of dexmedetomidine. Clin Pharmacokinet. 2017;56(8):893–913.
   PubMed Web of Science ®Google Scholar
• Mandelli M, Tognoni G, Garattini S. Clinical pharmacokinetics of diazepam. Clin Pharmacokinet. 1978;3(1):72–91.
   PubMed Web of Science ®Google Scholar
• Friedman H, Greenblatt DJ, Peters GR, et al. Pharmacokinetics and pharmacodynamics of oral diazepam: effect of dose, plasma concentration, and time. Clin Pharmacol Ther. 1992;52(2):139–150.
   PubMed Web of Science ®Google Scholar
• Greenblatt DJ, Divoll Allen M, Harmatz JS, et al. Diazepam disposition determinants. Clin Pharmacol Ther. 1980;27(3):301–312.
   PubMed Web of Science ®Google Scholar
• Krishna DR, Klotz U. Newer H 2-receptor antagonists. Clinical pharmacokinetics and drug interaction potential. Clin Pharmacokinet. 1988;15(4):205–215.
   PubMed Web of Science ®Google Scholar
• Maples HD, James LP, Stowe CD, et al. Famotidine disposition in children and adolescents with chronic renal insufficiency. J Clin Pharmacol. 2003;43(1):7–14.
   PubMed Web of Science ®Google Scholar
• Howden CW, Tytgat GNJ. The tolerability and safety profile of famotidine. Clin Ther. 1996;18(1):36–54.
   PubMed Web of Science ®Google Scholar
• Lin JH. Pharmacokinetic and pharmacodynamic properties of histamine H2-receptor antagonists: relationship between intrinsic potency and effective plasma concentrations. Clin Pharmacokinet. 1991;20(3):218–236.
   PubMed Web of Science ®Google Scholar
• Ohbuchi M, Noguchi K, Kawamura A, et al. Different effects of proton pump inhibitors and famotidine on the clopidogrel metabolic activation by recombinant CYP2B6, CYP2C19 and CYP3A4. Xenobiotica. 2012;42(7):633–640.
   PubMed Web of Science ®Google Scholar
• Olkkola KT, Hamunen K, Maunuksela E-L. Clinical pharmacokinetics and pharmacodynamics of opioid analgesics in infants and children. Clin Pharmacokinet. 1995;28(5):385–404.
   PubMed Web of Science ®Google Scholar
• Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl and sufentanil. An update. Clin Pharmacokinet. 1996;31(4):275–292.
   PubMed Web of Science ®Google Scholar
• Andreasen F, Hansen U, Husted SE, et al. The pharmacokinetics of frusemide are influenced by age. Br J Clin Pharmacol. 1983;16(4):391–397.
   PubMed Web of Science ®Google Scholar
• Ponto LL, Schoenwald RD. Furosemide (frusemide). A pharmacokinetic/pharmacodynamic review (Part I). Clin Pharmacokinet. 1990;18:381–408.
   PubMedGoogle Scholar
• Waller ES, Hamilton SF, Massarella JW, et al. Disposition and absolute bioavailability of furosemide in healthy males. J Pharm Sci. 1982;71(10):1105–1108.
   PubMed Web of Science ®Google Scholar
• Kerdpin O, Knights KM, Elliot DJ, et al. In vitro characterisation of human renal and hepatic frusemide glucuronidation and identification of the UDP-glucuronosyltransferase enzymes involved in this pathway. Biochem Pharmacol. 2008;76(2):249–257.
   PubMed Web of Science ®Google Scholar
• Zaske DE, Cipolle RJ, Rotschafer JC, et al. Gentamicin pharmacokinetics in 1,640 patients: method for control of serum concentrations. Antimicrob Agents Chemother. 1982;21(3):407–411.
   PubMed Web of Science ®Google Scholar
• Regamey C, Gordon RC, Kirby WMM. Comparative pharmacokinetics of tobramycin and gentamicin. Clin Pharmacol Ther. 1973;14(3):396–403.
   PubMed Web of Science ®Google Scholar
• Derendorf H, Mollmann H, Barth J, et al. Pharmacokinetics and oral bioavailability of hydrocortisone. J Clin Pharmacol. 1991;31(5):473–476.
   PubMed Web of Science ®Google Scholar
• Czock D, Keller F, Rasche FM, et al. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44:61–98.
   PubMed Web of Science ®Google Scholar
• Sarkar U, Rivera-Burgos D, Large EM, et al. Metabolite profiling and pharmacokinetic evaluation of hydrocortisone in a perfused three-dimensional human liver bioreactor. Drug Metab Dispos. 2015;43(7):1091–1099.
   PubMed Web of Science ®Google Scholar
• Furuta T, Mori C, Suzuki A, et al. Simultaneous determination of 6β-hydroxycortisol and cortisol in human urine by liquid chromatography with ultraviolet absorbance detection for phenotyping the CYP3A activity determined by the cortisol 6β-hydroxylation clearance. J Chromatogr B Anal Technol Biomed Life Sci. 2004;801(2):165–171.
   PubMed Web of Science ®Google Scholar
• Mazaleuskayaa LL, Thekena KN, Gong L, et al. PharmGKB summary: ibuprofen pathways. Pharmacogenet Genomics. 2015;25(2):96–106.
   PubMed Web of Science ®Google Scholar
• Lee EJ, Williams KM, Day R, et al. Stereoselective disposition of ibuprofen enantiomers in man. Br J Clin Pharmacol. 1985;19(5):669–674.
   PubMed Web of Science ®Google Scholar
• Lockwood GF, Albert KS, Gillespie WR, et al. Pharmacokinetics of ibuprofen in man. I. free and total area/dose relationships. Clin Pharmacol Ther. 1983;34(1):97–103.
   PubMed Web of Science ®Google Scholar
• Strolin Benedetti M, Whomsley R, Nicolas JM, et al. Pharmacokinetics and metabolism of 14C-levetiracetam, a new antiepileptic agent, in healthy volunteers. Eur J Clin Pharmacol. 2003;59(8–9):621–630.
   PubMed Web of Science ®Google Scholar
• Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707–724.
   PubMed Web of Science ®Google Scholar
• Greenblatt DJ. Clinical pharmacokinetics of oxazepam and lorazepam. Clin Pharmacokinet. 1981;6(2):89–105.
   PubMed Web of Science ®Google Scholar
• Anderson GD, Lynn AM. Optimizing pediatric dosing: A developmental pharmacologic approach. Pharmacotherapy. 2009;29(6):680–690.
   PubMed Web of Science ®Google Scholar
• Dyer KR, Foster D, White JM, et al. Steady‐state pharmacokinetics and pharmacodynamics in methadone maintenance patients: comparison of those who do and do not experience withdrawal and concentration‐effect relationships. Clin Pharmacol Ther. 1999;65(6):685–694.
   PubMed Web of Science ®Google Scholar
• Inturrisi CE, Colburn WA, Kaiko RF, et al. Pharmacokinetics and pharmacodynamics of methadone in patients with chronic pain. Clin Pharmacol Ther. 1987;41(4):392–401.
   PubMed Web of Science ®Google Scholar
• Kharasch ED, Hoffer C, Whittington D, et al. Role of hepatic and intestinal cytochrome P450 3A and 2B6 in the metabolism, disposition, and miotic effects of methadone. Clin Pharmacol Ther. 2004;76(3):250–269.
   PubMed Web of Science ®Google Scholar
• Rohatagi S, Barth J, Möllmann H, et al. Pharmacokinetics of methylprednisolone and prednisolone after single and multiple oral administration. J Clin Pharmacol. 1997;37(10):916–925.
   PubMed Web of Science ®Google Scholar
• Thummel KE, O’Shea D, Paine MF, et al. Oral first‐pass elimination of midazolam involves both gastrointestinal and hepatic CYP3A‐mediated metabolism. Clin Pharmacol Ther. 1996;59(5):491–502.
   PubMed Web of Science ®Google Scholar
• Miller A, McKee A, Mazer CD Sedation, analgesia, and related topics [Internet]. Second Edi. Cardiothorac. Crit. Care. Elsevier Inc. 2007. doi:10.1016/B978-0-7506-7572-7.50007-2.
   Google Scholar
• Berkowitz BA. The relationship of pharmacokinetics to pharmacological activity: morphine, methadone and naloxone. Clin Pharmacokinet. 1976;1(3):188–219.
   Google Scholar
• Roila F, Del Favero A. Ondansetron clinical pharmacokinetics. Clin Pharmacokinet. 1995;29(2):95–109.
   PubMed Web of Science ®Google Scholar
• Yang SH, Lee MG. Effects of cytochrome P450 (CYP) inducers and inhibitors on ondansetron pharmacokinetics in rats: involvement of hepatic CYP2D subfamily and 3A1/2 in ondansetron metabolism. J Pharm Pharmacol. 2008;60:853–861.
   PubMed Web of Science ®Google Scholar
• Culy CR, Bhana N, Plosker GL. Ondansetron a review of its use as an antiemetic in children. Paediatr Drugs. 2001;3(6):441–479.
   PubMedGoogle Scholar
• Ordóñez Gallego A, González Barón M, Espinosa Arranz E. Oxycodone: a pharmacological and clinical review. Clin Transl Oncol. 2007;9:298–307.
   PubMed Web of Science ®Google Scholar
• Benziger DP, Kaiko RF, Miotto JB, et al. Differential effects of food on the bioavailability of controlled‐release oxycodone tablets and immediate‐release oxycodone solution. J Pharm Sci. 1996;85(4):407–410.
   PubMed Web of Science ®Google Scholar
• Takala A, Kaasalainen V, Seppälä T, et al. Pharmacokinetic comparison of intravenous and intranasal administration of oxycodone. Acta Anaesthesiol Scand. 1997;41(2):309–312.
   PubMed Web of Science ®Google Scholar
• Frey BM, Frey FJ. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokinet. 1990;19(2):126–146.
   PubMed Web of Science ®Google Scholar
• Colangelo PM, Blouin RA, Steinmetz JE, et al. Age and propranolol stereoselective disposition in humans. Clin Pharmacol Ther. 1992;51(5):489–494.
   PubMed Web of Science ®Google Scholar
• Walle T, Conradi EC, Walle UK, et al. 4‐Hydroxypropranolol and its glucuronide after single and long‐term doses of propranolol. Clin Pharmacol Ther. 1980;27(1):22–31.
   PubMed Web of Science ®Google Scholar
• Masubuchi Y, Hosokawa S, Horie T, et al. Cytochrome P450 isozymes involved in propranolol metabolism in human liver microsomes. The role of CYP2D6 as ring-hydroxylase and CYP1A2 as N-desisopropylase. Drug Metab Dispos. 1994;22:909–915.
   PubMed Web of Science ®Google Scholar
• Mansur AP, Avakian SD, Paula RS, et al. Pharmacokinetics and pharmacodynamics of propranolol in hypertensive patients after sublingual administration: systemic availability. Braz J Med Biol Res. 1998;31:691–696.
   PubMed Web of Science ®Google Scholar
• Walker DK. Pharmacokinetics and metabolism of sildenafil in mouse, rat, rabbit, dog and man. Xenobiotica. 1999;29(3):297–310.
   PubMed Web of Science ®Google Scholar
• Zhao P, Vieira MDLT, Grillo JA, et al. Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation. J Clin Pharmacol. 2012;52(S1):91S–108S.
   PubMedGoogle Scholar
• Marsot A, Boulamery A, Bruguerolle B, et al. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet. 2012;51(1):1–13.
   PubMed Web of Science ®Google Scholar
• Leader WG, Chandler MHH, Castiglia M. Pharmacokinetic optimisation of vancomycin therapy. Clin Pharmacokinet. 1995;28(4):327–342.
   PubMed Web of Science ®Google Scholar
• Golper TA, Noonan HM, Elzinga L, et al. Vancomycin pharmacokinetics, renal handling, and nonrenal clearances in normal human subjects. Clin Pharmacol Ther. 1988;43:565–570.
   PubMed Web of Science ®Google Scholar
• Momper JD, Yang J, Gockenbach M, et al. Dynamics of organic anion transporter-mediated tubular secretion during postnatal human kidney development and maturation. Clin J Am Soc Nephrol. 2019;14(4):540–548.
   PubMed Web of Science ®Google Scholar
• Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol. 2003;17(3):281–299.
   PubMed Web of Science ®Google Scholar
• Shimada T, Yamazaki H, Mimura M, et al. Characterization of microsomal cytochrome P450 enzymes involved in the oxidation of xenobiotic chemicals in human fetal liver and adult lungs. Drug Metab Dispos. 1996;24:515–522.
   PubMed Web of Science ®Google Scholar
• Shimada T, Yamazaki H, Mimura M, et al. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. J Pharmacol Exp Ther. 1994;270:414–423.
   PubMed Web of Science ®Google Scholar
• Jedrychowski WA, Perera FP, Camann D, et al. Prenatal exposure to polycyclic aromatic hydrocarbons and cognitive dysfunction in children. Environ Sci Pollut Res. 2015;22(5):3631–3639.
   PubMed Web of Science ®Google Scholar
• Alsabri SG, Mari WO, Younes S, et al. Kinetic and dynamic description of caffeine. J Caffeine Adenosine Res. 2018;8(1):3–9.
   Google Scholar
• J V A, Cook CE, Gorman W, et al. Pharmacokinetic profile of caffeine in the premature newborn infant with apnea. J Pediatr. 1979;94(4):663–668.
   PubMed Web of Science ®Google Scholar
• Tanner J-A, Prasad B, Claw KG, et al. Predictors of variation in CYP2A6 mRNA, protein, and enzyme activity in a human liver bank: influence of genetic and nongenetic factors. J Pharmacol Exp Ther. 2017;360(1):129–139.
   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):965–974.
   PubMed Web of Science ®Google Scholar
• Treluyer JM, Cheron G, Sonnier M, et al. Cytochrome P-450 expression in sudden infant death syndrome. Biochem Pharmacol. 1996;52(3):497–504.
   PubMed Web of Science ®Google Scholar
• Figueiras A, Estany-Gestal A, Aguirre C, et al. CYP2C9 variants as a risk modifier of NSAID-related gastrointestinal bleeding: a case-control study. Pharmacogenet Genomics. 2016;26(2):66–73.
   PubMed Web of Science ®Google Scholar
• Ingelman-Sundberg M. Genetic polymorphisms of cytochrome P450 2D6 (CYP2D6): clinical consequences, evolutionary aspects and functional diversity. Pharmacogenomics J. 2005;5(1):6–13.
   PubMed Web of Science ®Google Scholar
• Stevens JC, Marsh SA, Zaya MJ, et al. Developmental changes in human liver CYP2D6 expression. Drug Metab Dispos. 2008;36(8):1587–1593.
   PubMed Web of Science ®Google Scholar
• Johnson TN, Tucker GT, Rostami‐Hodjegan A. Development of CYP2D6 and CYP3A4 in the first year of life. Clin Pharmacol Ther. 2008;83(5):670–671.
   PubMed Web of Science ®Google Scholar
• Gaedigk A, Dinh JC, Jeong H, et al. Ten years’ experience with the CYP2D6 activity score: a perspective on future investigations to improve clinical predictions for precision therapeutics. J Pers Med. 2018;8(2):15.
   PubMed Web of Science ®Google Scholar
• Drozdzik M, Busch D, Lapczuk J, et al. Protein abundance of clinically relevant drug‐metabolizing enzymes in the human liver and intestine: a comparative analysis in paired tissue specimens. Clin Pharmacol Ther. 2018;104(3):515–524.
   PubMed Web of Science ®Google Scholar
• Hines RN. Ontogeny of human hepatic cytochromes P450. J Biochem Mol Toxicol. 2007;21(4):169–175.
   PubMed Web of Science ®Google Scholar
• Johnson TN, Tanner MS, Taylor CJ, et al. Enterocytic CYP3A4 in a paediatric population: developmental changes and the effect of coeliac disease and cystic fibrosis. Br J Clin Pharmacol. 2001;51(5):451–460.
   PubMed Web of Science ®Google Scholar
• Völler S, Flint RB, Andriessen P, et al. Rapidly maturing fentanyl clearance in preterm neonates. Arch Dis Child Fetal Neonatal Ed. 2019;104(6):F598–F603.
   PubMed Web of Science ®Google Scholar
• Vyhlidal CA, Bi C, Ye SQ, et al. Dynamics of cytosine methylation in the proximal promoters of CYP3A4 and CYP3A7 in pediatric and prenatal livers. Drug Metab Dispos. 2016;44(7):1020–1026.
   PubMed Web of Science ®Google Scholar
• Koukouritaki SB, Simpson P, Yeung CK, et al. Human hepatic flavin-containing monooxygenases 1 (FMO1) and 3 (FMO3) developmental expression. Pediatr Res. 2002;51(2):236–243.
   PubMed Web of Science ®Google Scholar
• Dolphin CT, Cullingford TE, Shcphard EA, et al. Differential developmental and tissue‐specific regulation of expression of the genes encoding three members of the flavin‐containing monooxygenase family of man, FMO1, FMO3 and FMO4. Eur J Biochem. 1996;235(3):683–689.
   PubMedGoogle Scholar
• Yeung CK, Lang DH, Thummel KE, et al. Immunoquantitation of FMO1 in human liver, kidney, and intestine. Drug Metab Dispos. 2000;28:1107–1111.
   PubMed Web of Science ®Google Scholar
• Zhang J, Cashman JR. Quantitative analysis of fmo gene mrna levels in human tissues. Drug Metab Dispos. 2006;34(1):19–26.
   PubMed Web of Science ®Google Scholar
• Chen Y, Zane NR, Thakker DR, et al. Quantification of flavin-containing monooxygenases 1, 3, and 5 in human liver microsomes by UPLC-MRM-based targeted quantitative proteomics and its application to the study of ontogeny. Drug Metab Dispos. 2016;44(7):975–983.
   PubMed Web of Science ®Google Scholar
• Zane NR, Chen Y, Wang MZ, et al. Cytochrome P450 and flavin-containing monooxygenase families: age-dependent differences in expression and functional activity. Pediatr Res. 2018;83(2):527–535.
   PubMed Web of Science ®Google Scholar
• Xu M, Bhatt DK, Yeung CK, et al. Genetic and nongenetic factors associated with protein abundance of flavin-containing monooxygenase 3 in human liver. J Pharmacol Exp Ther. 2017;363(2):265–274.
   PubMed Web of Science ®Google Scholar
• Edenberg HJ, Bosron WF. 4.06 - Alcohol Dehydrogenases. In: McQueen CABT-CT (Second E, editor. Oxford: Elsevier; 2010. p. 111–130. Available from: http://www.sciencedirect.com/science/article/pii/B9780080468846004061. https://doi.org/10.1016/B978-0-08-046884-6.00406-1
   Google Scholar
• Smith M, Hopkinson DA, Harris H. Developmental changes and polymorphism in human alcohol dehydrogenase. Ann Hum Genet. 1971;34(3):251–271.
   PubMedGoogle Scholar
• Bhatt DK, Gaedigk A, Pearce RE, et al. Age-dependent protein abundance of cytosolic alcohol and aldehyde dehydrogenases in human liver. Drug Metab Dispos. 2017;45(9):1044–1048.
   PubMed Web of Science ®Google Scholar
• Smith DA, Hammond T, Baillie TA. Safety assessment of acyl glucuronides—a simplified paradigm. Drug Metab Dispos. 2018;46(6):908–912.
   PubMed Web of Science ®Google Scholar
• Williams JA, Hyland R, Jones BC, et al. Drug-drug interactions for udp-glucuronosyltransferase substrates: a pharmacokinetic explanation for typically observed low exposure (AUCI/AUC) ratios. Drug Metab Dispos. 2004;32(11):1201–1208.
   PubMed Web of Science ®Google Scholar
• Kawade N, Onishi S. The prenatal and postnatal development of UDP-glucuronyltransferase activity. Biochem J. 1981;196(1):257–260.
   PubMed Web of Science ®Google Scholar
• Ciotti M, Obaray R, Martín MG, et al. Genetic defects at the UGT1 locus associated with Crigler-Najjar type I disease, including a prenatal diagnosis. Am J Med Genet. 1997;68(2):173–178.
   PubMed Web of Science ®Google Scholar
• Clarke DJ, Moghrabi N, Monaghan G, et al. Genetic defects of the UDP-glucuronosyltransferase-1 (UGT1) gene that cause familial non-haemolytic unconjugated hyperbilirubinaemias. Clin Chim Acta. 1997;266(1):63–74.
   PubMed Web of Science ®Google Scholar
• Bosma PJ, Chowdhury JR, Bakker C, et al. The genetic basis of the reduced expression of bilirubin udp-glucuronosyltransferase 1 in gilbert’s syndrome. N Engl J Med. 1995;333(18):1171–1175.
   PubMed Web of Science ®Google Scholar
• Blake MJ, Castro L, Leeder JS, et al. Ontogeny of drug metabolizing enzymes in the neonate. Semin Fetal Neonatal Med. 2005;10(2):123–138.
   PubMed Web of Science ®Google Scholar
• King CD, Rios GR, Assouline JA, et al. Expression of UDP-glucuronosyltransferases (UGTs) 2B7 and 1A6 in the human brain and identification of 5-hydroxytryptamine as a substrate. Arch Biochem Biophys. 1999;365(1):156–162.
   PubMed Web of Science ®Google Scholar
• Bock KW, Forster A, Gschaidmeier H, et al. Paracetamol glucuronidation by recombinant rat and human phenol UDP-glucuronosyltransferases. Biochem Pharmacol. 1993;45(9):1809–1814.
   PubMed Web of Science ®Google Scholar
• Blanchet M, Bru G, Guerret M, et al. Routine determination of morphine, morphine 3-β-D-glucuronide and morphine 6-β-D-glucuronide in human serum by liquid chromatography coupled to electrospray mass spectrometry. J Chromatogr A. 1999;854(1–2):93–108.
   PubMed Web of Science ®Google Scholar
• Coffman BL, Rios GR, King CD, et al. Human UGT2B7 catalyzes morphine glucuronidation. Drug Metab Dispos. 1997;25:1–4.
   PubMed Web of Science ®Google Scholar
• Smith HS. Opioid metabolism. Mayo Clin Proc. 2009;84(7):613–624.
   PubMed Web of Science ®Google Scholar
• Venkatasubramanian R, Fukuda T, Niu J, et al. ABCC3 and OCT1 genotypes influence pharmacokinetics of morphine in children. Pharmacogenomics. 2014;15(10):1297–1309.
   PubMed Web of Science ®Google Scholar
• Glare PA, Walsh TD. Clinical pharmacokinetics of morphine. Ther Drug Monit. 1991;13(1):1–23.
   PubMed Web of Science ®Google Scholar
• Pacifici GM, Säwe J, Kager L, et al. Morphine glucuronidation in human fetal and adult liver. Eur J Clin Pharmacol. 1982;22(6):553–558.
   PubMed Web of Science ®Google Scholar
• Pacifici GM, Franchi M, Giuliani L, et al. Development of the glucuronyltransferase and sulphotransferase towards 2-naphthol in human fetus. Dev Pharmacol Ther. 1990;14:108–114.
   Google Scholar
• The ontogeny of drug metabolism enzymes and implications for adverse drug events. Pharmacol Ther [Internet]. 2008 ;118:250–267. cited 2020 May 6. Available from http://www.sciencedirect.com/science/article/pii/S0163725808000375
   PubMed Web of Science ®Google Scholar
• Uchaipichat V, Suthisisang C, Miners JO. The glucuronidation of R- and S-lorazepam: human liver microsomal kinetics, UDP-glucuronosyltransferase enzyme selectivity, and inhibition by drugs. Drug Metab Dispos. 2013;41(6):1273–1284.
   PubMed Web of Science ®Google Scholar
• Blanchard RL, Freimuth RR, Buck J, et al. A proposed nomenclature system for the cytosolic sulfotransferase (SULT) superfamily. Pharmacogenet Genomics. 2004;14(3):199–211.
   Google Scholar
• Hume R, E V B, Coughtrie MWH. Differential expression and immunohistochemical localisation of the phenol and hydroxysteroid sulphotransferase enzyme families in the developing lung. Histochem Cell Biol. 1996;105(2):147–152.
   PubMed Web of Science ®Google Scholar
• Richard K, Hume R, Kaptein E, et al. Sulfation of thyroid hormone and dopamine during human development: ontogeny of phenol sulfotransferases and arylsulfatase in liver, lung, and brain. J Clin Endocrinol Metab. 2001;86:2734–2742.
   PubMed Web of Science ®Google Scholar
• Adjei AA, Gaedigk A, Simon SD, et al. Interindividual variability in acetaminophen sulfation by human fetal liver: implications for pharmacogenetic investigations of drug‐induced birth defects. Birth Defects Res A Clin Mol Teratol. 2008;82(3):155–165.
   PubMedGoogle Scholar
• Duanmu Z, Weckle A, Koukouritaki SB, et al. Developmental expression of aryl, estrogen, and hydroxysteroid sulfotransferases in pre-and postnatal human liver. J Pharmacol Exp Ther. 2006;316(3):1310–1317.
   PubMed Web of Science ®Google Scholar
• Mitra A, Hilbelink DR, Dwornik JJ, et al. A novel model to assess developmental toxicity of dihaloalkanes in humans: bioactivation of 1, 2‐dibromoethane by the isozymes of human fetal liver glutathione S‐transferase. Teratog Carcinog Mutagen. 1992;12(3):113–127.
   PubMedGoogle Scholar
• Strange RC, Davis BA, Faulder CG, et al. The human glutathione S-transferases: developmental aspects of the GST1, GST2, and GST3 loci. Biochem Genet. 1985;23(11–12):1011–1028.
   PubMed Web of Science ®Google Scholar
• Strange RC, Howie AF, Hume R, et al. The developmental expression of alpha-, mu-and pi-class glutathione S-transferases in human liver. Biochim Biophys Acta. 1989;993(2–3):186–190.
   PubMedGoogle Scholar
• Pacifici GM, Rane A. Metabolism of styrene oxide in different human fetal tissues. Drug Metab Dispos. 1982;10:302–305.
   PubMed Web of Science ®Google Scholar
• Pacifici GM, Franchi M, Colizzi C, et al. Glutathione S-transferase in humans: development and tissue distribution. Arch Toxicol. 1988;61(4):265–269.
   PubMed Web of Science ®Google Scholar
• Pacifici GM, Bencini C, Rane A. Acetyltransferase in humans: development and tissue distribution. Pharmacology. 1986;32(5):283–291.
   PubMed Web of Science ®Google Scholar
• Pons G, Rey E, Carrier O, et al. Maturation of AFMU excretion in infants. Fundam Clin Pharmacol. 1989;3(6):589–595.
   PubMed Web of Science ®Google Scholar
• Elmorsi Y, Barber J, Rostami-Hodjegan A. Ontogeny of hepatic drug transporters and relevance to drugs used in pediatrics. Drug Metab Dispos. 2016;44(7):992–998.
   PubMed Web of Science ®Google Scholar
• Balyan R, Zhang X, Chidambaran V, et al. OCT1 genetic variants are associated with postoperative morphine-related adverse effects in children. Pharmacogenomics. 2017;18:621–629.
   PubMed Web of Science ®Google Scholar
• *Emoto C, Johnson TN, Neuhoff S, et al. PBPK model of morphine incorporating developmental changes in hepatic OCT1 and UGT2B7 proteins to explain the variability in clearances in neonates and small infants. CPT Pharmacometrics Syst Pharmacol. 2018;7(7):464–473.
   PubMedGoogle Scholar
• Fukuda T, Chidambaran V, Mizuno T, et al. OCT1 genetic variants influence the pharmacokinetics of morphine in children. Pharmacogenomics. 2013;14(10):1141–1151.
   PubMed Web of Science ®Google Scholar
• Haycock GB. Development of glomerular filtration and tubular sodium reabsorption in the human fetus and newborn. Br J Urol. 1998;81(S2):33–38.
   PubMedGoogle Scholar
• Bueva A, Guignard JP. Renal function in preterm neonates. Pediatr Res. 1994;36(5):572–577.
   PubMed Web of Science ®Google Scholar
• Alcorn J, McNamara PJ. Pharmacokinetics in the newborn. Adv Drug Deliv Rev. 2003;55(5):667–686.
   PubMed Web of Science ®Google Scholar
• **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(12):1157–1167.
   PubMed Web of Science ®Google Scholar
• Hook JB, Hewitt WR. Development of mechanisms for drug excretion. Am J Med. 1977;62(4):497–506.
   PubMed Web of Science ®Google Scholar
• Fetterman GH, Shuplock NA, Philipp FJ, et al. The growth and maturation of human glomeruli and proximal convolutions from term to adulthood: studies by microdissection. Pediatrics. 1965;35:601–619.
   PubMed Web of Science ®Google Scholar
• Rowland M. Protein binding and drug clearance. Clin Pharmacokinet. 1984;9(Supplement 1):10–17.
   PubMedGoogle Scholar
• Hayton WL. Maturation and growth of renal function: dosing renally cleared drugs in children. AAPS PharmSci. 2000;2(1):22–28.
   Google Scholar
• Gruskin AB, Edelmann CM, Yuan S. Maturational changes in renal blood flow in piglets. Pediatr Res. 1970;4:7–13.
   PubMed Web of Science ®Google Scholar
• Bueters R, Bael A, Gasthuys E, et al. Ontogeny and cross-species comparison of pathways involved in drug absorption, distribution, metabolism, and excretion in neonates (review): kidney. Drug Metab Dispos. 2020;48(5):353–367.
   PubMed Web of Science ®Google Scholar
• Strolin M, Whomsley R, Baltes EL. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations. Expert Opin Drug Metab Toxicol. 2005;1:447–471.
   PubMed Web of Science ®Google Scholar
• Brown RD, Campoli-Richards DM. Antimicrobial therapy in neonates, infants and children. Clin Pharmacokinet. 1989;17(Supplement 1):105–115.
   PubMedGoogle Scholar
• Peterson RG, Simmons MA, Rumack BH, et al. Pharmacology of furosemide in the premature newborn infant. J Pediatr. 1980;97(1):139–143.
   PubMed Web of Science ®Google Scholar
• Kelly MR, Cutler RE, Forrey AW, et al. Pharmacokinetics of orally administered furosemide. Clin Pharmacol Ther. 1974;15(2):178–186.
   PubMed Web of Science ®Google Scholar
• Li CY, Hosey-Cojocari C, Basit A, et al. Optimized renal transporter quantification by using aquaporin 1 and aquaporin 2 as anatomical markers: application in characterizing the ontogeny of renal transporters and its correlation with hepatic transporters in paired human samples. Aaps J. [Internet]. 2019;21(5):88.
   PubMed Web of Science ®Google Scholar
• Cheung KWK, van Groen BD, Spaans E, et al. A comprehensive analysis of ontogeny of renal drug transporters: mRNA analyses, quantitative proteomics, and localization. Clin Pharmacol Ther. 2019;106(5):1083–1092.
   PubMed Web of Science ®Google Scholar
• Jacobs RF, Kearns GL, Brown AL, et al. Renal clearance of imipenem in children. Eur J Clin Microbiol. 1984;3(5):471–474.
   PubMedGoogle Scholar
• Linday LA, Engle MA, Reidenberg MM. Maturation and renal digoxin clearance. Clin Pharmacol Ther. 1981;30(6):735–738.
   PubMed Web of Science ®Google Scholar
• Koren G, Hesslein PS, MacLeod SM. Digoxin toxicity associated with amiodarone therapy in children. J Pediatr. 1984;104(3):467–470.
   PubMed Web of Science ®Google Scholar
• Nigam SK, Bhatnagar V. How much do we know about drug handling by SLC and ABC drug transporters in children? Clin Pharmacol Ther. 2013;94(1):27–29.
   PubMed Web of Science ®Google Scholar
• Pavlova A, Sakurai H, Leclercq B, et al. Developmentally regulated expression of organic ion transporters NKT (OAT1), OCT1, NLT (OAT2), and Roct. Am J Physiol - Ren Physiol. 2000;278(4):635–643.
   PubMed Web of Science ®Google Scholar
• Eraly SA, Vallon V, Vaughn DA, et al. Decreased renal organic anion secretion and plasma accumulation of endogenous organic anions in OAT1 knock-out mice. J Biol Chem. 2006;281(8):5072–5083.
   PubMed Web of Science ®Google Scholar
• Nigam SK, Bush KT, Martovetsky G, et al. The organic anion transporter (OAT) family: a systems biology perspective. Physiol Rev. 2015;95(1):83–123.
   PubMed Web of Science ®Google Scholar
• Yin J, Wang J. Renal drug transporters and their significance in drug-drug interactions. Acta Pharm Sin B [Internet]. 2016;6:363–373.
   PubMed Web of Science ®Google Scholar
• Hua MJ, Kun HY, Jie CS, et al. Urinary microalbumin and retinol-binding protein assay for verifying children’s nephron development and maturation. Clin Chim Acta. 1997;264(1):127–132.
   PubMed Web of Science ®Google Scholar
• Leeder JS. Ontogeny of drug-metabolizing enzymes and its influence on the pathogenesis of adverse drug reactions in children. Curr Ther Res - Clin Exp. 2001;62(12):900–912.
   Web of Science ®Google Scholar
• Shi D, Yang D, Prinssen EP, et al. Surge in expression of carboxylesterase 1 during the post-neonatal stage enables a rapid gain of the capacity to activate the anti-influenza prodrug oseltamivir. J Infect. 2011;203(7):937–942.
   Google Scholar
• Avant D, Baer G, Moore J, et al. Neonatal safety information reported to the FDA during drug development studies. Ther Innov Regul Sci. 2018;52(1):100–108.
   Web of Science ®Google Scholar
• Rishoej RM, Almarsdóttir AB, Christesen HT, et al. Medication errors in pediatric inpatients: a study based on a national mandatory reporting system. Eur J Pediatr. 2017;176(12):1697–1705.
   PubMed Web of Science ®Google Scholar
• Dean L. Codeine Therapy and CYP2D6 Genotype. 2012 Sep 20 [updated 2017 Mar 16]. In: Pratt VM, McLeod HL, Rubinstein WS, Scott SA, Dean LC, Kattman BL, Malheiro AJ, editors. Medical Genetics Summaries [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2012–. PMID: 28520350.
   Google Scholar
• Food and Drug Administration (FDA). Use of codeine and tramadol products in breastfeeding women [Internet]. 2019 cited 2020 Aug 1. Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/use-codeine-and-tramadol-products-breastfeeding-women-questions-and-answers
   Google Scholar
• Perry C, Davis G, Conner TM, et al. Utilization of physiologically based pharmacokinetic modeling in clinical pharmacology and therapeutics: an overview. Curr Pharmacol Reports. 2020;6(3):71–84.
   Google Scholar
• Pearce RE, Gaedigk R, Twist GP, et al. Developmental expression of CYP2B6: a comprehensive analysis of mRNA expression, protein content and bupropion hydroxylase activity and the impact of genetic variation. Drug Metab Dispos. 2016;44(7):948–958.
   PubMed Web of Science ®Google Scholar
• Zaya MJ, Hines RN, Stevens JC. Epirubicin glucuronidation and UGT2B7 developmental expression. Drug Metab Dispos. 2006;34(12):2097–2101.
   PubMed Web of Science ®Google Scholar
• Kearns GL, Jungbluth GL, Abdel-Rahman SM, et al. Impact of ontogeny on linezolid disposition in neonates and infants. Clin Pharmacol Ther. 2003;74(5):413–422.
   PubMed Web of Science ®Google Scholar
• Payne K, Mattheyse FJ, Liebenberg D, et al. The pharmacokinetics of midazolam in paediatric patients. Eur J Clin Pharmacol. 1989;37(3):267–272.
   PubMed Web of Science ®Google Scholar
• Boberg M, Vrana M, Mehrotra A, et al. Age-dependent absolute abundance of hepatic carboxylesterases (CES1 and CES2) by LC-MS/MS proteomics: application to PBPK modeling of oseltamivir in vivo pharmacokinetics in infants. Drug Metab Dispos. 2017;45(2):216–223.
   PubMed Web of Science ®Google Scholar
• Smits A, Annaert P, Allegaert K. Biomarkers of propofol metabolism in neonates: the quest beyond ontogeny. Biomark Med England. 2017;11(11):933–936.
   PubMed Web of Science ®Google Scholar
• Mian P, Allegaert K, Conings S, et al. Integration of placental transfer in a fetal-maternal physiologically based pharmacokinetic model to characterize acetaminophen exposure and metabolic clearance in the fetus. Clin Pharmacokinet. 2020;59(7):911–925.
   PubMed Web of Science ®Google Scholar
• Emoto C, Fukuda T, Johnson TN, et al. Characterization of contributing factors to variability in morphine clearance through PBPK modeling implemented with OCT1 transporter. CPT Pharmacometrics Syst Pharmacol. 2017;6(2):110–119.
   PubMedGoogle Scholar
• Strougo A, Eissing T, Yassen A, et al. First dose in children: physiological insights into pharmacokinetic scaling approaches and their implications in paediatric drug development. J Pharmacokinet Pharmacodyn. 2012;39(2):195–203.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. General clinical pharmacology considerations for pediatric studies for drugs and biological products (Draft). 2014;1–25. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm425885.pdf
   Google Scholar
• Food and Drug Administration (FDA). 21 CFR 314.108 - New drug product exclusivity. [Internet]. cited 2020 Jul 29. Available from: https://www.govinfo.gov/app/details/CFR-2012-title21-vol5/CFR-2012-title21-vol5-sec314–108
   Google Scholar
• Food and Drug Administration. Good Review Practices [Internet]. cited 2020 Jul 29. Available from: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/good-review-practices-grps
   Google Scholar
• FDA. Draft guidance for industry - pediatric study plans: content of and process for submitting initial pediatric study plans and amended pediatric study plans. FDA Guid [Internet]. 2016;115:13. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM360507.pdf.
   Google Scholar
• Rodrigues D, Rowland A. From endogenous compounds as biomarkers to plasma-derived nanovesicles as liquid biopsy; has the golden age of translational pharmacokinetics-absorption, distribution, metabolism, excretion-drug-drug interaction science finally arrived? Clin Pharmacol Ther. 2019;105(6):1407–1420.
   PubMed Web of Science ®Google Scholar
• Rowland A, Ruanglertboon W, Dyk M, et al. Plasma extracellular nanovesicle (exosome)‐derived biomarkers for drug metabolism pathways: a novel approach to characterize variability in drug exposure. Br J Clin Pharmacol. 2019;85(1):216–226.
   PubMed Web of Science ®Google Scholar
• Wagner C, Zhao P, Pan Y, et al. Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK. CPT Pharmacometrics Syst Pharmacol. 2015;4(4):226–230.
   PubMedGoogle Scholar