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For: Manolis E, Pons G. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework. Br J Clin Pharmacol. 2009;68:493-501. [PMID: 19843052 DOI: 10.1111/j.1365-2125.2009.03484.x] [Cited by in Crossref: 90] [Cited by in F6Publishing: 61] [Article Influence: 8.2] [Reference Citation Analysis]
Number Citing Articles
1 Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A. Role of modeling and simulation in pediatric investigation plans. Paediatr Anaesth 2011;21:214-21. [PMID: 21244569 DOI: 10.1111/j.1460-9592.2011.03523.x] [Cited by in Crossref: 59] [Cited by in F6Publishing: 50] [Article Influence: 5.9] [Reference Citation Analysis]
2 Hampson LV, Herold R, Posch M, Saperia J, Whitehead A. Bridging the gap: a review of dose investigations in paediatric investigation plans. Br J Clin Pharmacol 2014;78:898-907. [PMID: 24720849 DOI: 10.1111/bcp.12402] [Cited by in Crossref: 11] [Cited by in F6Publishing: 8] [Article Influence: 1.8] [Reference Citation Analysis]
3 Cole S, Hay JL, Luzon E, Nordmark A, Rusten IS. European regulatory perspective on pediatric physiologically based pharmacokinetic models. International Journal of Pharmacokinetics 2017;2:113-24. [DOI: 10.4155/ipk-2016-0025] [Cited by in Crossref: 5] [Cited by in F6Publishing: 2] [Article Influence: 1.3] [Reference Citation Analysis]
4 Cella M, Knibbe C, Danhof M, Della Pasqua O. What is the right dose for children? Br J Clin Pharmacol 2010;70:597-603. [PMID: 21087295 DOI: 10.1111/j.1365-2125.2009.03591.x] [Cited by in Crossref: 84] [Cited by in F6Publishing: 60] [Article Influence: 8.4] [Reference Citation Analysis]
5 Vinks AA, Emoto C, Fukuda T. Modeling and simulation in pediatric drug therapy: Application of pharmacometrics to define the right dose for children. Clin Pharmacol Ther. 2015;98:298-308. [PMID: 26073179 DOI: 10.1002/cpt.169] [Cited by in Crossref: 58] [Cited by in F6Publishing: 49] [Article Influence: 9.7] [Reference Citation Analysis]
6 Germovsek E, Barker CIS, Sharland M, Standing JF. Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance. Clin Pharmacokinet 2019;58:39-52. [PMID: 29675639 DOI: 10.1007/s40262-018-0659-0] [Cited by in Crossref: 22] [Cited by in F6Publishing: 18] [Article Influence: 22.0] [Reference Citation Analysis]
7 Bellanti F, Di Iorio VL, Danhof M, Della Pasqua O. Sampling Optimization in Pharmacokinetic Bridging Studies: Example of the Use of Deferiprone in Children With β-Thalassemia. J Clin Pharmacol 2016;56:1094-103. [PMID: 26785826 DOI: 10.1002/jcph.708] [Cited by in Crossref: 7] [Cited by in F6Publishing: 5] [Article Influence: 1.4] [Reference Citation Analysis]
8 Holford NHG, Nutt JG. Interpreting the results of Parkinson's disease clinical trials: Time for a change: Modeling Parkinson's Disease Clinical Trials. Mov Disord 2011;26:569-77. [DOI: 10.1002/mds.23555] [Cited by in Crossref: 16] [Cited by in F6Publishing: 14] [Article Influence: 1.6] [Reference Citation Analysis]
9 Zisowsky J, Krause A, Dingemanse J. Drug Development for Pediatric Populations: Regulatory Aspects. Pharmaceutics 2010;2:364-88. [PMID: 27721363 DOI: 10.3390/pharmaceutics2040364] [Cited by in Crossref: 51] [Cited by in F6Publishing: 45] [Article Influence: 4.6] [Reference Citation Analysis]
10 Harnisch L, Shepard T, Pons G, Della Pasqua O. Modeling and simulation as a tool to bridge efficacy and safety data in special populations. CPT Pharmacometrics Syst Pharmacol 2013;2:e28. [PMID: 23835939 DOI: 10.1038/psp.2013.6] [Cited by in Crossref: 24] [Cited by in F6Publishing: 22] [Article Influence: 3.0] [Reference Citation Analysis]
11 Kechagia IA, Kalantzi L, Dokoumetzidis A. Extrapolation of enalapril efficacy from adults to children using pharmacokinetic/pharmacodynamic modelling. J Pharm Pharmacol 2015;67:1537-45. [PMID: 26256099 DOI: 10.1111/jphp.12471] [Cited by in Crossref: 6] [Cited by in F6Publishing: 4] [Article Influence: 1.0] [Reference Citation Analysis]
12 Vogt W. Evaluation and Optimisation of Current Milrinone Prescribing for the Treatment and Prevention of Low Cardiac Output Syndrome in Paediatric Patients After Open Heart Surgery Using a Physiology-Based Pharmacokinetic Drug–Disease Model. Clin Pharmacokinet 2014;53:51-72. [DOI: 10.1007/s40262-013-0096-z] [Cited by in Crossref: 17] [Cited by in F6Publishing: 13] [Article Influence: 2.1] [Reference Citation Analysis]
13 Mangas-sanjuan V, González-álvarez I, González-álvarez M, Casabó VG, Bermejo M. Modified Nonsink Equation for Permeability Estimation in Cell Monolayers: Comparison with Standard Methods. Mol Pharmaceutics 2014;11:1403-14. [DOI: 10.1021/mp400555e] [Cited by in Crossref: 13] [Cited by in F6Publishing: 11] [Article Influence: 1.9] [Reference Citation Analysis]
14 Khalil F, Läer S. Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development. J Biomed Biotechnol. 2011;2011:907461. [PMID: 21716673 DOI: 10.1155/2011/907461] [Cited by in Crossref: 61] [Cited by in F6Publishing: 46] [Article Influence: 6.1] [Reference Citation Analysis]
15 D'Agate S, Musuamba FT, Jacqz-Aigrain E, Della Pasqua O. Simplified Dosing Regimens for Gentamicin in Neonatal Sepsis. Front Pharmacol 2021;12:624662. [PMID: 33762945 DOI: 10.3389/fphar.2021.624662] [Reference Citation Analysis]
16 van Hasselt JG, van Eijkelenburg NK, Beijnen JH, Schellens JH, Huitema AD. Optimizing drug development of anti-cancer drugs in children using modelling and simulation. Br J Clin Pharmacol 2013;76:30-47. [PMID: 23216601 DOI: 10.1111/bcp.12062] [Cited by in Crossref: 21] [Cited by in F6Publishing: 18] [Article Influence: 3.0] [Reference Citation Analysis]
17 Turner MA, Catapano M, Hirschfeld S, Giaquinto C; Global Research in Paediatrics. Paediatric drug development: the impact of evolving regulations. Adv Drug Deliv Rev 2014;73:2-13. [PMID: 24556465 DOI: 10.1016/j.addr.2014.02.003] [Cited by in Crossref: 89] [Cited by in F6Publishing: 63] [Article Influence: 12.7] [Reference Citation Analysis]
18 Allegaert K. Better medicines for neonates: Improving medicine development, testing, and prescribing. Early Hum Dev 2017;114:22-5. [PMID: 28899617 DOI: 10.1016/j.earlhumdev.2017.09.007] [Cited by in Crossref: 5] [Cited by in F6Publishing: 4] [Article Influence: 1.3] [Reference Citation Analysis]
19 Cho M, Qiu Z, Ye J, Quan H, Zhao PL. Considerations for pediatric trial designs and analyses. J Biopharm Stat 2018;28:413-36. [PMID: 28872409 DOI: 10.1080/10543406.2017.1372771] [Reference Citation Analysis]
20 Piana C, Danhof M, Della Pasqua O. Influence of covariate distribution on the predictive performance of pharmacokinetic models in paediatric research. Br J Clin Pharmacol 2014;78:145-57. [PMID: 24433411 DOI: 10.1111/bcp.12322] [Cited by in Crossref: 7] [Cited by in F6Publishing: 6] [Article Influence: 1.2] [Reference Citation Analysis]
21 Brussee JM, Calvier EA, Krekels EH, Välitalo PA, Tibboel D, Allegaert K, Knibbe CA. Children in clinical trials: towards evidence-based pediatric pharmacotherapy using pharmacokinetic-pharmacodynamic modeling. Expert Rev Clin Pharmacol 2016;9:1235-44. [PMID: 27269200 DOI: 10.1080/17512433.2016.1198256] [Cited by in Crossref: 20] [Cited by in F6Publishing: 19] [Article Influence: 4.0] [Reference Citation Analysis]
22 Howard M, Barber J, Alizai N, Rostami-Hodjegan A. Dose adjustment in orphan disease populations: the quest to fulfill the requirements of physiologically based pharmacokinetics. Expert Opin Drug Metab Toxicol 2018;14:1315-30. [PMID: 30465453 DOI: 10.1080/17425255.2018.1546288] [Cited by in Crossref: 7] [Cited by in F6Publishing: 6] [Article Influence: 2.3] [Reference Citation Analysis]
23 Allegaert K. Clinical pharmacological studies in children: From exploratory towards confirmation driven methodology. World J Clin Pediatr. 2012;1:3-7. [PMID: 25254160 DOI: 10.5409/wjcp.v1.i2.3] [Cited by in CrossRef: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.1] [Reference Citation Analysis]
24 Zheng S, Gaitonde P, Andrew MA, Gibbs MA, Lesko LJ, Schmidt S. Model-based assessment of dosing strategies in children for monoclonal antibodies exhibiting target-mediated drug disposition. CPT Pharmacometrics Syst Pharmacol 2014;3:e138. [PMID: 25271939 DOI: 10.1038/psp.2014.38] [Cited by in Crossref: 8] [Cited by in F6Publishing: 4] [Article Influence: 1.1] [Reference Citation Analysis]
25 Mian P, Allegaert K, Spriet I, Tibboel D, Petrovic M. Paracetamol in Older People: Towards Evidence-Based Dosing? Drugs Aging. 2018;35:603-624. [PMID: 29916138 DOI: 10.1007/s40266-018-0559-x] [Cited by in Crossref: 9] [Cited by in F6Publishing: 5] [Article Influence: 4.5] [Reference Citation Analysis]
26 Cella M, Knibbe C, de Wildt SN, Van Gerven J, Danhof M, Della Pasqua O. Scaling of pharmacokinetics across paediatric populations: the lack of interpolative power of allometric models. Br J Clin Pharmacol 2012;74:525-35. [PMID: 22300419 DOI: 10.1111/j.1365-2125.2012.04206.x] [Cited by in Crossref: 14] [Cited by in F6Publishing: 11] [Article Influence: 1.8] [Reference Citation Analysis]
27 Barrett JS, Della Casa Alberighi O, Läer S, Meibohm B. Physiologically Based Pharmacokinetic (PBPK) Modeling in Children. Clin Pharmacol Ther 2012;92:40-9. [DOI: 10.1038/clpt.2012.64] [Cited by in Crossref: 129] [Cited by in F6Publishing: 102] [Article Influence: 14.3] [Reference Citation Analysis]
28 Peck CC. Quantitative clinical pharmacology is transforming drug regulation. J Pharmacokinet Pharmacodyn 2010;37:617-28. [PMID: 20978827 DOI: 10.1007/s10928-010-9171-3] [Cited by in Crossref: 18] [Cited by in F6Publishing: 14] [Article Influence: 1.6] [Reference Citation Analysis]
29 Pflieger M, Bertram D. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan]. Arch Pediatr 2014;21:1129-38. [PMID: 25175054 DOI: 10.1016/j.arcped.2014.07.011] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 0.3] [Reference Citation Analysis]
30 Parrott N, Davies B, Hoffmann G, Koerner A, Lave T, Prinssen E, Theogaraj E, Singer T. Development of a Physiologically Based Model for Oseltamivir and Simulation of Pharmacokinetics in Neonates and Infants: . Clinical Pharmacokinetics 2011;50:613-23. [DOI: 10.2165/11592640-000000000-00000] [Cited by in Crossref: 78] [Cited by in F6Publishing: 62] [Article Influence: 7.8] [Reference Citation Analysis]
31 Johnson TN, Rostami-hodjegan A. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice: Applications of pediatric PBPK modeling. Pediatric Anesthesia 2011;21:291-301. [DOI: 10.1111/j.1460-9592.2010.03323.x] [Cited by in Crossref: 119] [Cited by in F6Publishing: 95] [Article Influence: 11.9] [Reference Citation Analysis]
32 Heikkinen AT, Lignet F, Cutler P, Parrott N. The role of quantitative ADME proteomics to support construction of physiologically based pharmacokinetic models for use in small molecule drug development. Prot Clin Appl 2015;9:732-44. [DOI: 10.1002/prca.201400147] [Cited by in Crossref: 25] [Cited by in F6Publishing: 20] [Article Influence: 4.2] [Reference Citation Analysis]
33 Thai HT, Mazuir F, Cartot-Cotton S, Veyrat-Follet C. Optimizing pharmacokinetic bridging studies in paediatric oncology using physiologically-based pharmacokinetic modelling: application to docetaxel. Br J Clin Pharmacol 2015;80:534-47. [PMID: 26095234 DOI: 10.1111/bcp.12702] [Cited by in Crossref: 23] [Cited by in F6Publishing: 19] [Article Influence: 3.8] [Reference Citation Analysis]
34 Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, Rowland M, Schneider CK, Bloechl-Daum B. Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov 2011;10:495-506. [PMID: 21720406 DOI: 10.1038/nrd3501] [Cited by in Crossref: 184] [Cited by in F6Publishing: 125] [Article Influence: 18.4] [Reference Citation Analysis]
35 Edginton AN, Joshi G. Have physiologically-based pharmacokinetic models delivered? Expert Opinion on Drug Metabolism & Toxicology 2011;7:929-34. [DOI: 10.1517/17425255.2011.585968] [Cited by in Crossref: 8] [Cited by in F6Publishing: 6] [Article Influence: 0.8] [Reference Citation Analysis]
36 Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol 2011;67 Suppl 1:75-86. [PMID: 21246352 DOI: 10.1007/s00228-010-0974-3] [Cited by in Crossref: 59] [Cited by in F6Publishing: 49] [Article Influence: 5.9] [Reference Citation Analysis]
37 Miao L, Mousa YM, Zhao L, Raines K, Seo P, Wu F. Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations. AAPS J 2020;22. [DOI: 10.1208/s12248-020-00493-6] [Cited by in Crossref: 10] [Cited by in F6Publishing: 7] [Article Influence: 10.0] [Reference Citation Analysis]
38 Block M. Physiologically based pharmacokinetic and pharmacodynamic modeling in cancer drug development: status, potential and gaps. Expert Opin Drug Metab Toxicol 2015;11:743-56. [PMID: 25940026 DOI: 10.1517/17425255.2015.1037276] [Cited by in Crossref: 14] [Cited by in F6Publishing: 5] [Article Influence: 2.8] [Reference Citation Analysis]
39 Piana C, Danhof M, Della Pasqua O. Impact of disease, drug and patient adherence on the effectiveness of antiviral therapy in pediatric HIV. Expert Opin Drug Metab Toxicol 2017;13:497-511. [PMID: 28043170 DOI: 10.1080/17425255.2017.1277203] [Cited by in Crossref: 3] [Cited by in F6Publishing: 2] [Article Influence: 0.8] [Reference Citation Analysis]
40 Jadhav PR, Kern SE. The need for modeling and simulation to design clinical investigations in children. J Clin Pharmacol 2010;50:121S-9S. [PMID: 20881225 DOI: 10.1177/0091270010376968] [Cited by in Crossref: 19] [Cited by in F6Publishing: 13] [Article Influence: 1.9] [Reference Citation Analysis]
41 Coppini R, Simons SHP, Mugelli A, Allegaert K. Clinical research in neonates and infants: Challenges and perspectives. Pharmacol Res 2016;108:80-7. [PMID: 27142783 DOI: 10.1016/j.phrs.2016.04.025] [Cited by in Crossref: 29] [Cited by in F6Publishing: 19] [Article Influence: 5.8] [Reference Citation Analysis]
42 Hamberg AK, Wadelius M. Pharmacogenetics-based warfarin dosing in children. Pharmacogenomics 2014;15:361-74. [PMID: 24533715 DOI: 10.2217/pgs.14.8] [Cited by in Crossref: 9] [Cited by in F6Publishing: 8] [Article Influence: 1.3] [Reference Citation Analysis]
43 Bellanti F, van Wijk RC, Danhof M, Della Pasqua O. Integration of PKPD relationships into benefit-risk analysis. Br J Clin Pharmacol 2015;80:979-91. [PMID: 25940398 DOI: 10.1111/bcp.12674] [Cited by in Crossref: 12] [Cited by in F6Publishing: 4] [Article Influence: 2.0] [Reference Citation Analysis]
44 Jorga K, Chavanne C, Frey N, Lave T, Lukacova V, Parrott N, Peck R, Reigner B. Bottom-up Meets Top-down: Complementary Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling for Regulatory Approval of a Dosing Algorithm of Valganciclovir in Very Young Children. Clin Pharmacol Ther 2016;100:761-9. [PMID: 27530217 DOI: 10.1002/cpt.449] [Cited by in Crossref: 20] [Cited by in F6Publishing: 19] [Article Influence: 4.0] [Reference Citation Analysis]
45 Smits A, Annaert P, Cavallaro G, De Cock PAJG, de Wildt SN, Kindblom JM, Lagler FB, Moreno C, Pokorna P, Schreuder MF, Standing JF, Turner MA, Vitiello B, Zhao W, Weingberg AM, Willmann R, van den Anker J, Allegaert K. Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper. Br J Clin Pharmacol 2021. [PMID: 34180088 DOI: 10.1111/bcp.14958] [Reference Citation Analysis]
46 Manolis E, Herold R. Pharmacometrics for regulatory decision making: status and perspective. Clin Pharmacokinet 2011;50:625-6. [PMID: 21895035 DOI: 10.2165/11594340-000000000-00000] [Cited by in Crossref: 16] [Cited by in F6Publishing: 11] [Article Influence: 1.8] [Reference Citation Analysis]
47 Abernethy DR, Burckart GJ. Pediatric Dose Selection. Clin Pharmacol Ther 2010;87:270-1. [DOI: 10.1038/clpt.2009.292] [Cited by in Crossref: 30] [Cited by in F6Publishing: 22] [Article Influence: 2.7] [Reference Citation Analysis]
48 Rocchi F, Tomasi P. The development of medicines for children. Part of a series on Pediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni. Pharmacol Res 2011;64:169-75. [PMID: 21376810 DOI: 10.1016/j.phrs.2011.01.016] [Cited by in Crossref: 39] [Cited by in F6Publishing: 26] [Article Influence: 3.9] [Reference Citation Analysis]
49 van Donge T, Evers K, Koch G, van den Anker J, Pfister M. Clinical Pharmacology and Pharmacometrics to Better Understand Physiological Changes During Pregnancy and Neonatal Life. Handb Exp Pharmacol 2020;261:325-37. [PMID: 30968215 DOI: 10.1007/164_2019_210] [Cited by in Crossref: 3] [Cited by in F6Publishing: 3] [Article Influence: 3.0] [Reference Citation Analysis]
50 Bellanti F, Danhof M, Della Pasqua O. Population pharmacokinetics of deferiprone in healthy subjects. Br J Clin Pharmacol 2014;78:1397-406. [PMID: 25052529 DOI: 10.1111/bcp.12473] [Cited by in Crossref: 11] [Cited by in F6Publishing: 9] [Article Influence: 1.8] [Reference Citation Analysis]
51 Venkatakrishnan K, Ecsedy JA. Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science. Clin Pharmacol Ther 2017;101:99-113. [PMID: 27804123 DOI: 10.1002/cpt.544] [Cited by in Crossref: 16] [Cited by in F6Publishing: 11] [Article Influence: 3.2] [Reference Citation Analysis]
52 Zhao W, Leroux S, Jacqz-Aigrain E. Dosage individualization in children: integration of pharmacometrics in clinical practice. World J Pediatr 2014;10:197-203. [PMID: 25124969 DOI: 10.1007/s12519-014-0493-x] [Cited by in Crossref: 13] [Cited by in F6Publishing: 11] [Article Influence: 1.9] [Reference Citation Analysis]
53 Cella M, Danhof M, Della Pasqua O. Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children. Br J Clin Pharmacol 2012;74:346-53. [PMID: 22256787 DOI: 10.1111/j.1365-2125.2012.04187.x] [Cited by in Crossref: 14] [Cited by in F6Publishing: 12] [Article Influence: 1.6] [Reference Citation Analysis]
54 Manolis E, Rohou S, Hemmings R, Salmonson T, Karlsson M, Milligan PA. The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop. CPT Pharmacometrics Syst Pharmacol 2013;2:e31. [PMID: 23835942 DOI: 10.1038/psp.2013.7] [Cited by in Crossref: 35] [Cited by in F6Publishing: 32] [Article Influence: 4.4] [Reference Citation Analysis]
55 Mulberg AE, Bucci-Rechtweg C, Giuliano J, Jacoby D, Johnson FK, Liu Q, Marsden D, McGoohan S, Nelson R, Patel N, Romero K, Sinha V, Sitaraman S, Spaltro J, Kessler V. Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders. Orphanet J Rare Dis 2019;14:36. [PMID: 30736861 DOI: 10.1186/s13023-019-1017-5] [Cited by in Crossref: 17] [Cited by in F6Publishing: 8] [Article Influence: 8.5] [Reference Citation Analysis]
56 Hamberg AK, Wadelius M, Friberg LE, Biss TT, Kamali F, Jonsson EN. Characterizing variability in warfarin dose requirements in children using modelling and simulation. Br J Clin Pharmacol 2014;78:158-69. [PMID: 24330000 DOI: 10.1111/bcp.12308] [Cited by in Crossref: 12] [Cited by in F6Publishing: 7] [Article Influence: 2.0] [Reference Citation Analysis]
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60 Xu Z, Davis HM, Zhou H. Rational development and utilization of antibody-based therapeutic proteins in pediatrics. Pharmacology & Therapeutics 2013;137:225-47. [DOI: 10.1016/j.pharmthera.2012.10.005] [Cited by in Crossref: 41] [Cited by in F6Publishing: 32] [Article Influence: 5.1] [Reference Citation Analysis]
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