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Page 1
Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.
Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Job KM, et al. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5. Clin Pharmacol Ther. 2022. PMID: 35076931 Free PMC article.
Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity.
Wen J, McCann S, Balevic SJ, Muller WJ, Hornik CD, Autmizguine J, Anderson SG, Payne EH, Turdalieva S, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Wen J, et al. J Clin Pharmacol. 2024 Dec;64(12):1491-1504. doi: 10.1002/jcph.6108. Epub 2024 Aug 9. J Clin Pharmacol. 2024. PMID: 39120865
Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.
McCann S, Helfer VE, Balevic SJ, Hornik CD, Goldstein SL, Autmizguine J, Meyer M, Al-Uzri A, Anderson SG, Payne EH, Turdalieva S, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. McCann S, et al. J Clin Pharmacol. 2024 Aug;64(8):963-974. doi: 10.1002/jcph.2434. Epub 2024 Mar 28. J Clin Pharmacol. 2024. PMID: 38545761
Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.
Randell RL, Balevic SJ, Greenberg RG, Cohen-Wolkowiez M, Thompson EJ, Venkatachalam S, Smith MJ, Bendel C, Bliss JM, Chaaban H, Chhabra R, Dammann CEL, Downey LC, Hornik C, Hussain N, Laughon MM, Lavery A, Moya F, Saxonhouse M, Sokol GM, Trembath A, Weitkamp J-H, Hornik CP; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Randell RL, et al. Antimicrob Agents Chemother. 2024 Apr 3;68(4):e0153323. doi: 10.1128/aac.01533-23. Epub 2024 Mar 14. Antimicrob Agents Chemother. 2024. PMID: 38477706 Free PMC article.
Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants.
Ganguly S, Edginton AN, Gerhart JG, Cohen-Wolkowiez M, Greenberg RG, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Ganguly S, et al. Clin Pharmacokinet. 2021 Dec;60(12):1591-1604. doi: 10.1007/s40262-021-01046-6. Epub 2021 Jun 22. Clin Pharmacokinet. 2021. PMID: 34155614 Free PMC article.
External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.
Wu YSS, Cohen-Wolkowiez M, Hornik CP, Gerhart JG, Autmizguine J, Cobbaert M, Gonzalez D; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Wu YSS, et al. Antimicrob Agents Chemother. 2021 Jun 17;65(7):e0214920. doi: 10.1128/AAC.02149-20. Epub 2021 Jun 17. Antimicrob Agents Chemother. 2021. PMID: 33903114 Free PMC article.
Physiologically-Based Pharmacokinetic Modeling Characterizes the CYP3A-Mediated Drug-Drug Interaction Between Fluconazole and Sildenafil in Infants.
Salerno SN, Edginton A, Gerhart JG, Laughon MM, Ambalavanan N, Sokol GM, Hornik CD, Stewart D, Mills M, Martz K, Gonzalez D; Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Salerno SN, et al. Clin Pharmacol Ther. 2021 Jan;109(1):253-262. doi: 10.1002/cpt.1990. Epub 2020 Aug 22. Clin Pharmacol Ther. 2021. PMID: 32691891 Free PMC article.
Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.
Thompson EJ, Jeong A, Helfer VE, Shakhnovich V, Edginton A, Balevic SJ, James LP, Collier DN, Anand R, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Thompson EJ, et al. CPT Pharmacometrics Syst Pharmacol. 2024 Aug;13(8):1394-1408. doi: 10.1002/psp4.13167. Epub 2024 Jun 4. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 38837864 Free PMC article. Clinical Trial.