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Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach.

Current pharmaceutical design

Allegaert K, Cosaert K, van den Anker JN.
PMID: 26323412
Curr Pharm Des. 2015;21(39):5674-9. doi: 10.2174/1381612821666150901110207.

To attain effective and safe pharmacotherapy in neonates, caregivers have to consider both the clinical characteristics of the newborn and the pharmacokinetic estimates of a given compound during prescription and administration. Overall, clearance in neonates is low when compared...

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Allegaert K, Cosaert K, van den Anker JN. Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach. Curr Pharm Des. 2015;21(39):5674-9doi: 10.2174/1381612821666150901110207.
Allegaert, K., Cosaert, K., & van den Anker, J. N. (2015). Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach. Current pharmaceutical design, 21(39), 5674-9. https://doi.org/10.2174/1381612821666150901110207
Allegaert, Karel, et al. "Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach." Current pharmaceutical design vol. 21,39 (2015): 5674-9. doi: https://doi.org/10.2174/1381612821666150901110207
Allegaert K, Cosaert K, van den Anker JN. Neonatal Formulations: The Need for a Tailored, Knowledge Driven Approach. Curr Pharm Des. 2015;21(39):5674-9. doi: 10.2174/1381612821666150901110207. PMID: 26323412.
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High-dose gentamicin in newborn infants: is it safe?.

European journal of pediatrics

Fjalstad JW, Laukli E, van den Anker JN, Klingenberg C.
PMID: 24233331
Eur J Pediatr. 2013 Nov 14; doi: 10.1007/s00431-013-2194-1. Epub 2013 Nov 14.

Dosing regimens often recommend lower gentamicin doses in neonates (3-5 mg/kg) than in older children (7 mg/kg or more) despite the higher volume of distribution in neonates. We studied an extended-interval high-dose (6 mg/kg) gentamicin regimen in a single...

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Fjalstad JW, Laukli E, van den Anker JN, et al. High-dose gentamicin in newborn infants: is it safe?. Eur J Pediatr. 2013;doi: 10.1007/s00431-013-2194-1.
Fjalstad, J. W., Laukli, E., van den Anker, J. N., & Klingenberg, C. (2013). High-dose gentamicin in newborn infants: is it safe?. European journal of pediatrics, . https://doi.org/10.1007/s00431-013-2194-1
Fjalstad, Jon Widding, et al. "High-dose gentamicin in newborn infants: is it safe?." European journal of pediatrics vol. (2013). doi: https://doi.org/10.1007/s00431-013-2194-1
Fjalstad JW, Laukli E, van den Anker JN, Klingenberg C. High-dose gentamicin in newborn infants: is it safe?. Eur J Pediatr. 2013 Nov 14; doi: 10.1007/s00431-013-2194-1. Epub 2013 Nov 14. PMID: 24233331.
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Elusive sources of variability of dystrophin rescue by exon skipping.

Skeletal muscle

Vila MC, Klimek MB, Novak JS, Rayavarapu S, Uaesoontrachoon K, Boehler JF, Fiorillo AA, Hogarth MW, Zhang A, Shaughnessy C, Gordish-Dressman H, Burki U, Straub V, Lu QL, Partridge TA, Brown KJ, Hathout Y, van den Anker J, Hoffman EP, Nagaraju K.
PMID: 26634117
Skelet Muscle. 2015 Dec 01;5:44. doi: 10.1186/s13395-015-0070-6. eCollection 2015.

BACKGROUND: Systemic delivery of anti-sense oligonucleotides to Duchenne muscular dystrophy (DMD) patients to induce de novo dystrophin protein expression in muscle (exon skipping) is a promising therapy. Treatment with Phosphorodiamidate morpholino oligomers (PMO) lead to shorter de novo dystrophin...

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Vila MC, Klimek MB, Novak JS, et al. Elusive sources of variability of dystrophin rescue by exon skipping. Skelet Muscle. 2015;5:44doi: 10.1186/s13395-015-0070-6.
Vila, M. C., Klimek, M. B., Novak, J. S., Rayavarapu, S., Uaesoontrachoon, K., Boehler, J. F., Fiorillo, A. A., Hogarth, M. W., Zhang, A., Shaughnessy, C., Gordish-Dressman, H., Burki, U., Straub, V., Lu, Q. L., Partridge, T. A., Brown, K. J., Hathout, Y., van den Anker, J., Hoffman, E. P., & Nagaraju, K. (2015). Elusive sources of variability of dystrophin rescue by exon skipping. Skeletal muscle, 544. https://doi.org/10.1186/s13395-015-0070-6
Vila, Maria Candida, et al. "Elusive sources of variability of dystrophin rescue by exon skipping." Skeletal muscle vol. 5 (2015): 44. doi: https://doi.org/10.1186/s13395-015-0070-6
Vila MC, Klimek MB, Novak JS, Rayavarapu S, Uaesoontrachoon K, Boehler JF, Fiorillo AA, Hogarth MW, Zhang A, Shaughnessy C, Gordish-Dressman H, Burki U, Straub V, Lu QL, Partridge TA, Brown KJ, Hathout Y, van den Anker J, Hoffman EP, Nagaraju K. Elusive sources of variability of dystrophin rescue by exon skipping. Skelet Muscle. 2015 Dec 01;5:44. doi: 10.1186/s13395-015-0070-6. eCollection 2015. PMID: 26634117; PMCID: PMC4667482.
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Best pharmaceuticals for children: how far have we come?.

Current therapeutic research, clinical and experimental

Mazer-Amirshahi M, van den Anker J.
PMID: 25067983
Curr Ther Res Clin Exp. 2014 May 08;76:32-3. doi: 10.1016/j.curtheres.2013.05.001. eCollection 2014 Dec.

No abstract available.

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Mazer-Amirshahi M, van den Anker J. Best pharmaceuticals for children: how far have we come?. Curr Ther Res Clin Exp. 2014;76:32-3doi: 10.1016/j.curtheres.2013.05.001.
Mazer-Amirshahi, M., & van den Anker, J. (2014). Best pharmaceuticals for children: how far have we come?. Current therapeutic research, clinical and experimental, 7632-3. https://doi.org/10.1016/j.curtheres.2013.05.001
Mazer-Amirshahi, Maryann, and van den Anker, John. "Best pharmaceuticals for children: how far have we come?." Current therapeutic research, clinical and experimental vol. 76 (2014): 32-3. doi: https://doi.org/10.1016/j.curtheres.2013.05.001
Mazer-Amirshahi M, van den Anker J. Best pharmaceuticals for children: how far have we come?. Curr Ther Res Clin Exp. 2014 May 08;76:32-3. doi: 10.1016/j.curtheres.2013.05.001. eCollection 2014 Dec. PMID: 25067983; PMCID: PMC4008771.
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Topical nitroglycerin in neonates with tissue injury: A case report and review of the literature.

Paediatrics & child health

Samiee-Zafarghandy S, van den Anker JN, Ben Fadel N.
PMID: 24627647
Paediatr Child Health. 2014 Jan;19(1):9-12. doi: 10.1093/pch/19.1.9.

Peripheral tissue injury is one of the well-described morbidities associated with stays in the neonatal intensive care unit. Despite the potential long-term disability associated with this event, the current available therapeutic options remain very limited. Topical nitroglycerin has emerged...

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Samiee-Zafarghandy S, van den Anker JN, Ben Fadel N. Topical nitroglycerin in neonates with tissue injury: A case report and review of the literature. Paediatr Child Health. 2014;19(1):9-12doi: 10.1093/pch/19.1.9.
Samiee-Zafarghandy, S., van den Anker, J. N., & Ben Fadel, N. (2014). Topical nitroglycerin in neonates with tissue injury: A case report and review of the literature. Paediatrics & child health, 19(1), 9-12. https://doi.org/10.1093/pch/19.1.9
Samiee-Zafarghandy, Samira, et al. "Topical nitroglycerin in neonates with tissue injury: A case report and review of the literature." Paediatrics & child health vol. 19,1 (2014): 9-12. doi: https://doi.org/10.1093/pch/19.1.9
Samiee-Zafarghandy S, van den Anker JN, Ben Fadel N. Topical nitroglycerin in neonates with tissue injury: A case report and review of the literature. Paediatr Child Health. 2014 Jan;19(1):9-12. doi: 10.1093/pch/19.1.9. PMID: 24627647; PMCID: PMC3938212.
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Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study.

BMJ paediatrics open

Haslund-Krog SS, Hertel S, Dalhoff K, Poulsen S, Christensen U, Wilkins D, van den Anker J, Brink Henriksen T, Holst H.
PMID: 31206077
BMJ Paediatr Open. 2019 Mar 30;3(1):e000427. doi: 10.1136/bmjpo-2018-000427. eCollection 2019.

INTRODUCTION: Anticipated or actual pain in neonates results in use of paracetamol for prolonged pain relief in many neonatal intensive care units. Clinical trials examining safety of paracetamol exposure in neonates have been of short duration (1-3 days) and...

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Haslund-Krog SS, Hertel S, Dalhoff K, et al. Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study. BMJ Paediatr Open. 2019;3(1):e000427doi: 10.1136/bmjpo-2018-000427.
Haslund-Krog, S. S., Hertel, S., Dalhoff, K., Poulsen, S., Christensen, U., Wilkins, D., van den Anker, J., Brink Henriksen, T., & Holst, H. (2019). Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study. BMJ paediatrics open, 3(1), e000427. https://doi.org/10.1136/bmjpo-2018-000427
Haslund-Krog, Sissel Sundell, et al. "Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study." BMJ paediatrics open vol. 3,1 (2019): e000427. doi: https://doi.org/10.1136/bmjpo-2018-000427
Haslund-Krog SS, Hertel S, Dalhoff K, Poulsen S, Christensen U, Wilkins D, van den Anker J, Brink Henriksen T, Holst H. Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study. BMJ Paediatr Open. 2019 Mar 30;3(1):e000427. doi: 10.1136/bmjpo-2018-000427. eCollection 2019. PMID: 31206077; PMCID: PMC6542439.
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Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs.

Pharmaceutics

Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, Abdelrahman R, Wu K, Krudys KM, Fisher J, Slikker W, Chen C, Burckart GJ, Allegaert K.
PMID: 32698409
Pharmaceutics. 2020 Jul 20;12(7). doi: 10.3390/pharmaceutics12070685.

Drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. It is critically important that all...

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Van den Anker JN, McCune S, Annaert P, et al. Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs. Pharmaceutics. 2020;12(7)doi: 10.3390/pharmaceutics12070685.
Van den Anker, J. N., McCune, S., Annaert, P., Baer, G. R., Mulugeta, Y., Abdelrahman, R., Wu, K., Krudys, K. M., Fisher, J., Slikker, W., Chen, C., Burckart, G. J., & Allegaert, K. (2020). Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs. Pharmaceutics, 12(7), . https://doi.org/10.3390/pharmaceutics12070685
Van den Anker, John N, et al. "Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs." Pharmaceutics vol. 12,7 (2020). doi: https://doi.org/10.3390/pharmaceutics12070685
Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, Abdelrahman R, Wu K, Krudys KM, Fisher J, Slikker W, Chen C, Burckart GJ, Allegaert K. Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs. Pharmaceutics. 2020 Jul 20;12(7). doi: 10.3390/pharmaceutics12070685. PMID: 32698409; PMCID: PMC7408157.
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Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance.

Frontiers in pharmacology

Du B, Zhou Y, Tang BH, Wu YE, Yang XM, Shi HY, Yao BF, Hao GX, You DP, van den Anker J, Zheng Y, Zhao W.
PMID: 33790793
Front Pharmacol. 2021 Mar 15;12:630047. doi: 10.3389/fphar.2021.630047. eCollection 2021.

No abstract available.

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Du B, Zhou Y, Tang BH, et al. Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance. Front Pharmacol. 2021;12:630047doi: 10.3389/fphar.2021.630047.
Du, B., Zhou, Y., Tang, B. H., Wu, Y. E., Yang, X. M., Shi, H. Y., Yao, B. F., Hao, G. X., You, D. P., van den Anker, J., Zheng, Y., & Zhao, W. (2021). Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance. Frontiers in pharmacology, 12630047. https://doi.org/10.3389/fphar.2021.630047
Du, Bin, et al. "Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance." Frontiers in pharmacology vol. 12 (2021): 630047. doi: https://doi.org/10.3389/fphar.2021.630047
Du B, Zhou Y, Tang BH, Wu YE, Yang XM, Shi HY, Yao BF, Hao GX, You DP, van den Anker J, Zheng Y, Zhao W. Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance. Front Pharmacol. 2021 Mar 15;12:630047. doi: 10.3389/fphar.2021.630047. eCollection 2021. PMID: 33790793; PMCID: PMC8005605.
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Preventing Home Medication Administration Errors.

Pediatrics

Yin HS, Neuspiel DR, Paul IM, Franklin W, Tieder JS, Adirim T, Alvarez F, Brown JM, Bundy DG, Ferguson LE, Gleeson SP, Leu M, Mueller BU, Connor Phillips S, Quinonez RA, Rea C, Rinke ML, Shaikh U, Shiffman RN, Vickers Saarel E, Spencer Cockerham SP, Mack Walsh K, Jones B, Adler AC, Foster JH, Green TP, Houck CS, Laughon MM, Neville K, Reigart JR, Shenoi R, Sullivan JE, Van Den Anker JN, Verhoef PA.
PMID: 34851406
Pediatrics. 2021 Dec 01;148(6). doi: 10.1542/peds.2021-054666.

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low...

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Yin HS, Neuspiel DR, Paul IM, et al. Preventing Home Medication Administration Errors. Pediatrics. 2021;148(6)doi: 10.1542/peds.2021-054666.
Yin, H. S., Neuspiel, D. R., Paul, I. M., Franklin, W., Tieder, J. S., Adirim, T., Alvarez, F., Brown, J. M., Bundy, D. G., Ferguson, L. E., Gleeson, S. P., Leu, M., Mueller, B. U., Connor Phillips, S., Quinonez, R. A., Rea, C., Rinke, M. L., Shaikh, U., Shiffman, R. N., Vickers Saarel, E., Spencer Cockerham, S. P., Mack Walsh, K., Jones, B., Adler, A. C., Foster, J. H., Green, T. P., Houck, C. S., Laughon, M. M., Neville, K., Reigart, J. R., Shenoi, R., Sullivan, J. E., Van Den Anker, J. N., & Verhoef, P. A. (2021). Preventing Home Medication Administration Errors. Pediatrics, 148(6), . https://doi.org/10.1542/peds.2021-054666
Yin, H Shonna, et al. "Preventing Home Medication Administration Errors." Pediatrics vol. 148,6 (2021). doi: https://doi.org/10.1542/peds.2021-054666
Yin HS, Neuspiel DR, Paul IM, Franklin W, Tieder JS, Adirim T, Alvarez F, Brown JM, Bundy DG, Ferguson LE, Gleeson SP, Leu M, Mueller BU, Connor Phillips S, Quinonez RA, Rea C, Rinke ML, Shaikh U, Shiffman RN, Vickers Saarel E, Spencer Cockerham SP, Mack Walsh K, Jones B, Adler AC, Foster JH, Green TP, Houck CS, Laughon MM, Neville K, Reigart JR, Shenoi R, Sullivan JE, Van Den Anker JN, Verhoef PA. Preventing Home Medication Administration Errors. Pediatrics. 2021 Dec 01;148(6). doi: 10.1542/peds.2021-054666. PMID: 34851406.
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Creatinine Trends to Detect Ibuprofen-Related Maturational Adverse Drug Events in Neonatal Life: A Simulation Study for the ELBW Newborn.

Frontiers in pharmacology

van Donge T, Allegaert K, Pfister M, Smits A, van den Anker J.
PMID: 33569003
Front Pharmacol. 2021 Jan 25;11:610294. doi: 10.3389/fphar.2020.610294. eCollection 2020.

No abstract available.

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van Donge T, Allegaert K, Pfister M, et al. Creatinine Trends to Detect Ibuprofen-Related Maturational Adverse Drug Events in Neonatal Life: A Simulation Study for the ELBW Newborn. Front Pharmacol. 2021;11:610294doi: 10.3389/fphar.2020.610294.
van Donge, T., Allegaert, K., Pfister, M., Smits, A., & van den Anker, J. (2020). Creatinine Trends to Detect Ibuprofen-Related Maturational Adverse Drug Events in Neonatal Life: A Simulation Study for the ELBW Newborn. Frontiers in pharmacology, 11610294. https://doi.org/10.3389/fphar.2020.610294
van Donge, Tamara, et al. "Creatinine Trends to Detect Ibuprofen-Related Maturational Adverse Drug Events in Neonatal Life: A Simulation Study for the ELBW Newborn." Frontiers in pharmacology vol. 11 (2020): 610294. doi: https://doi.org/10.3389/fphar.2020.610294
van Donge T, Allegaert K, Pfister M, Smits A, van den Anker J. Creatinine Trends to Detect Ibuprofen-Related Maturational Adverse Drug Events in Neonatal Life: A Simulation Study for the ELBW Newborn. Front Pharmacol. 2021 Jan 25;11:610294. doi: 10.3389/fphar.2020.610294. eCollection 2020. PMID: 33569003; PMCID: PMC7868337.
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Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates.

The AAPS journal

Krzyzanski W, Smits A, Van Den Anker J, Allegaert K.
PMID: 34142253
AAPS J. 2021 Jun 17;23(4):86. doi: 10.1208/s12248-021-00612-x.

Serum creatinine (sCr) is a commonly measured biomarker to estimate glomerular filtration rate (GFR) and therefore widely used as a covariate in population pharmacokinetic models of renally excreted drugs. In neonates, sCr dynamically changes during the first few weeks...

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Krzyzanski W, Smits A, Van Den Anker J, et al. Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates. AAPS J. 2021;23(4):86doi: 10.1208/s12248-021-00612-x.
Krzyzanski, W., Smits, A., Van Den Anker, J., & Allegaert, K. (2021). Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates. The AAPS journal, 23(4), 86. https://doi.org/10.1208/s12248-021-00612-x
Krzyzanski, Wojciech, et al. "Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates." The AAPS journal vol. 23,4 (2021): 86. doi: https://doi.org/10.1208/s12248-021-00612-x
Krzyzanski W, Smits A, Van Den Anker J, Allegaert K. Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates. AAPS J. 2021 Jun 17;23(4):86. doi: 10.1208/s12248-021-00612-x. PMID: 34142253.
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Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children.

Journal of clinical pharmacology

Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH.
PMID: 29677389
J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20.

Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in children undergoing invasive procedures. Available for both intravenous and intramuscular administration, ketamine is commonly used when vascular access is limited. Pharmacokinetic (PK) data in children...

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Hornik CP, Gonzalez D, van den Anker J, et al. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018;58(8):1092-1104doi: 10.1002/jcph.1116.
Hornik, C. P., Gonzalez, D., van den Anker, J., Atz, A. M., Yogev, R., Poindexter, B. B., Ng, K. C., Delmore, P., Harper, B. L., Melloni, C., Lewandowski, A., Gelber, C., Cohen-Wolkowiez, M., Lee, J. H. (2018). Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. Journal of clinical pharmacology, 58(8), 1092-1104. https://doi.org/10.1002/jcph.1116
Hornik, Christoph P, et al. "Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children." Journal of clinical pharmacology vol. 58,8 (2018): 1092-1104. doi: https://doi.org/10.1002/jcph.1116
Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20. PMID: 29677389; PMCID: PMC6195858.
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