Publications

BPCA-funded research has led to many publications that fill knowledge gaps in pediatric pharmacology research.

ACYCLOVIR​

Ericson, J.E., Gostelow, M., Autmizguine, J., Hornik, C.P., Clark, R.H., Benjamin, D.K., Smith, P.B., (2017). Safety of High‐Dose Acyclovir in Infants with Neonatal Herpes Simplex Virus Infections. Pediatr Infect Dis J., 36(4), 369‐37. PMCID: PMC5348260

Sampson, M.R., Bloom, B.T., Lenfestey, R.W., Harper, B., Kashuba, A.D., Anand, R.,…Smith, P.B. (2014). Population pharmacokinetics of intravenous acyclovir in preterm and term infants. Pediatr Infect Dis J., 33, 42-49. PMID: 24346595.

AMIODARONE

Dallefeld, S.H., Atz, A.M., Yogev, R., Sullivan, J.E., Al-Uzri, A., Mendley, S.R.,…Cohen-Wolkowiez, M., (2018) A Pharmacokinetic Model for Amiodarone in Infants Developed from an Opportunistic Sampling Trial and Published Literature Data. J Pharmacokinet Pharmacodyn 45(3), 419-430. PMID: 29435949

AMPICILLIN

Le, J., Greenberg, R.G., Yoo, Y., Clark, R.H., Benjamin, D.K., Zimmerman, K.O.,…Wade., K.C. (2022). Ampicillin Dosing in Premature Infants for Early-Onset Sepsis: Exposure-Driven Efficacy, Safety, and Stewardship. J Perinatol. PMID: 35210541

Le, J., Poindexter, B., Sullivan, J.E., Laughon, M., Delmore, P., Blackford, M.,…Cohen-Wolkowiez, M., (2018) Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit, 40(1), 103-108. PMCID: PMC5764797

Hornik, C.P., Benjamin, D.K. Jr, Smith, P.B., Pencina, M.J., Tremoulet, A.H., Capparelli, E.V.,…Cohen-Wolkowiez, M., Best Pharmaceuticals for Children Act—Pediatric Trials Network. (2016) Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatrics, 16(3476), 30546-30547. PMID: 27522443. PMCID: PMC5085855

Tremoulet, A., Le, J., Poindexter, B., Sullivan, J.E., Laughon, M., Delmore, P.,…Cohen-Wolkowiez, M., on behalf of the Administrative Core Committee of the Best Pharmaceuticals for Children Act — Pediatric Trials Network. (2014) Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother, 58(6) 3013-3020. PMCID: PMC4068432

AZITHROMYCIN

Merchan, L.M., Hassan, H.E., Terrin, M.L., Waites, K.B., Kaufman, D.A., Ambalavanan, N.,…Viscardi, R.M. (2014). Pharmacokinetics, microbial response, and pulmonary outcomes of multi-dose intravenous azithromycin in preterm infants at risk for Ureaplasma respiratory colonization. Antimicrob Agents Chemother, 59, 570-578. PMID: 25385115.

Viscardi, R.M., Othman, A.A., Hassan, H.E., Eddington, N.D., Abebe, E., Terrin, M.L.,…Waites, K.B. (2013). Azithromycin to prevent bronchopulmonary dysplasia in Ureaplasma-infected preterm infants: pharmacokinetics, safety, microbial response, and clinical outcomes with a 20-milligram-per-kilogram single intravenous dose. Antimicrob Agents Chemother, 57, 2127-2133. PMID: 23439637. 

Pandelidis, K., McCarthy, A., Chesko, K.L., & Viscardi, R.M. (2013). Role of biofilm formation in Ureaplasma antibiotic susceptibility and development of bronchopulmonary dysplasia in preterm neonates. Pediatr Infect Dis J, 32, 394-398. PMID: 23114371.

Hassan, H.E., Othman, A.A., Eddington, N.D., Duffy, L., Xiao, L., Waites, K.B.,…Viscardi, R.M. (2011). Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for Ureaplasma colonization and bronchopulmonary dysplasia. J Clin Pharmacol, 51, 1264-1275. PMID: 21098694.

BACLOFEN

He, Y., Brunstrom-Hernandez, J.E., Thio, L.L., Lackey, S., Gaebler-Spira, D., Kuroda, M.M.,…Jusko, W.J. Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy. J Pediatrics, 164, 1181-1188. PMID: 24607242.

CAFFEINE CITRATE

Puia-Dumitrescu, M., Smith, P.B., Zhao, J., Soriano, A., Payne, E.H., Harper, B.,…Wade, K.C., Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2019) Dosing and Safety of Off-Label Use of Caffeine Citrate in Premature Infants. J Pediatrics PMID: 31101409

CEFEPIME

Arnold, C.J., Ericson, J.E., Cho, N., Tian, J., Wilson, S., Chu, V.H.,…Smith, P.B., on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. (2015)  Cefepime and Ceftazidime Safety in Hospitalized Infants. Pediatr Infect Dis J., 34(9) 964-968. PMCID: PMC4573537

CLINDAMYCIN

Smith, M.J., Gonzalez, D., Goldman, J.L., Yogev, R., Sullivan, J.E., Reed, M.D.,…Watt, K., on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2017) Pharmacokinetics of Clindamycin in Obese and Non‐obese Children. Antimicrob Agents Chemother, 61(4) PMCID: PMC5365720

Gonzalez, D., Delmore, P., Bloom, B.T., Cotton, C.M., Poindexter, B.B., McGowan, E.,…Laughon, M.M., on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2016) Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.  Antimicrob Agents Chemother, 60(5), 2888-2894. PMCID: PMC4862454

Gonzalez, D., Melloni, C., Yogev, R., Poindexter, B.B., Mendley, S.R., Delmore, P.,…Cohen-Wolkowiez, M., (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(4), 429-437. PMCID: PMC4169790

DEXAMETHASONE

Virkud, Y.V., Hornik, C.P., Benjamin, D.K., Laughon, M.M., Clark, R.H., Greenberg, R.G., Smith, P.B., (2017)  Respiratory Support for Very Low Birth Weight Infants Receiving Dexamethasone. J Pediatrics, 183, 26-30. PMCID: PMC5368005

DOPAMINE

Batton, B.J., Li, L., Newman, N.S., Das, A., Watterberg, K.L., Yoder, B.A.,…Walsh, M.C. Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. (2012).Feasibility study of early blood pressure management in extremely preterm infants. J Pediatrics, 161, 65-69.e1. PMID: 22336574.

ENALAPRIL

Ku, L.C., Zimmerman, K., Benjamin, D.K., Clark, R.H., Hornik, C.P., Smith, P.B., Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2017) Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit. Pediatr Cardiol , 38(1), 155-161. PMID: 27826711; PMCID: PMC5288129 

ERYTHROMYCIN

Ericson, J.E., Arnold, C., Cheeseman, J., Cho, J., Kaneko, S., Wilson, E.,…Hornik, C.P., Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. (2015) Use and safety of erythromycin and metoclopramide in hospitalized infants. J Pediatr Gastroenterol Nutr, 61(3), 334-339. PMCID: PMC4553109

FLUCONAZOLE

Ericson, J.E., Kaufman, D.A., Kicklighter, S.D., Bhatia, J., Testoni, D., Gao, J.,…Benjamin, D.K. Jr., Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee; Fluconazole Prophylaxis Study Team. (2016) Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data. Clin Infect Dis, 63(5), 604-610. PMID: 27298330; PMCID: PMC4981761

Benjamin, D.K. Jr, Hudak, M.L., Duara, S., Randolph, D.A., Bidegain, M., Mundakel, G.T.,…Smith, P.B., (2014) Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial. JAMA, 311(17), 1742-1749. volume 311, PMCID: PMC4110724

Piper, L., Smith, P.B., Hornik, C.P., Cheifetz, I.M., Barrett, J.S., Moorthy, G.,…Benjamin, D.K. Jr. (2011). Fluconazole loading dose pharmacokinetics and safety in infants. Pediatr Infect Dis J, 30, 375–378. Doi: 10.1097/INF.0b013e318202cbb3, PMID: 21085048.

HYDROXYUREA

Estepp, J.H., Melloni, C., Thornburg, C.D., Wiczling, P., Rogers, Z., Rothman, J.A.,…Neville, K.A., Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee. (2016) Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia. J Clin Pharmacol, 56(3), 298-306. PMCID: PMC4892120

Wang, W.C., Ware, R.E., Miller, S.T., Iyer, R.V., Casella, J.F., Minniti, C.P.,…Thompson, B.W., BABY HUG Investigators. (2011). Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG). Lancet, 377, 1663–1672. PMID: 21571150.

Roger, Z.R., Wang, W.C., Luo, Z., Lyer, R.V., Shalaby-Rana, E., Dertinger, S.D.,…Ware, R.E. BABY HUG. (2011). Biomarkers of splenic function in infants with sickle cell anemia: baseline data from the BABY HUG trial. Blood, 117, 2614–2617. Doi: 10.1182/blood-1010-04-278747. Epub 2011 Jan 7. PMID: 21217080.

KETAMINE

Shi, Q., Guo, L., Patterson, T.A., Dial, S., Li, Q., Sadovova, N.,…Wang, C. (2010). Gene expression profiling in the developing rat brain exposed to ketamine. Neuroscience166, 852–863. PMID: 20080153.

Hornik, C.P., Gonzalez, D., van den Anker, J., Atz, A.M., Yogev, R., Poindexter, B.B.,…Lee, J.H., Best Pharmaceuticals for Children Act – Pediatric Trials Network. (2018) Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol PMID: 29677389

Zou, X., Patterson, T.A., Sadovova, N., Twaddle, N.C., Doerge, D.R., Zhang, X.,…Wang, C. (2009). Potential neurotoxicity of ketamine in the developing rat brain. Tox Sci, 108, 149–158. PMID: 19126600.

Wang, C., Sadovova, N., Patterson, T.A., Zou, X., Fu, X., Hanig, J.P.,…Slikker, W. Jr. (2008). Protective effects of 7-nitroindazole on ketamine-induced neurotoxicity in rat forebrain culture. Neurotoxicology, 29, 613–620. PMID: 18456338.

Slikker, W. Jr., Zou, X., Hotchkiss, C.E., Divine, R.L., Sadovova, N., Twaddle, N.C.,…Wang, C. Ketamine-induced neuronal cell death in the perinatal rhesus monkey. Toxicol Sci, 98, 145–158. PMID: 17426105.

LISONAPRIL

Trachtman, H., Frymoyer, A., Lewandowski, A., Greenbaum, L.A., Feig, D.I., Gipson, D.S.,…Patel, U.D., Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee. (2015) Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection. Clinical Pharmacol Ther, 98(1), 25-33. PMCID: PMC4536255

LITHIUM

Landersdorfer, C.B., Findling, R.L., Frazier, J.A., Kafantaris, V., & Kirkpatrick, C.M. (2017). Lithium in paediatric patients with bipolar disorder: Implications for selection of dosage regimens via population pharmacokinetics/pharmacodynamics. Clin Pharmacokinet, 56, 77-90. doi: 10.1007/s40262-016-0430-3. PMID: 27393139.

Findling, R.L., Robb, A., McNamara, N.K., Pavuluri, M.N., Kafantaris, V., Scheffer, R.,…Taylor-Zapata P. (2015). Lithium in the acute treatment of bipolar I disorder: A double-blind, placebo-controlled study. Pediatrics, 136, 885-894. PMID: 26459650.

Findling, R.L., Kafantaris, V., Pavuluri, M., McNamara, N.K., Frazier, J.A., Sikich, L….Taylor-Zapata, P. (2013). Post-acute effectiveness of lithium in pediatric bipolar I disorder. J Child Adolesc Psychopharmacol, 23, 80-90. doi: 10.1089/cap.2012.0063. PMCID: PMC3609605.

Findling, R.L., Kafantaris, V., Pavuluri, M., McNamara, N.K., McClellan, J., Frazier, J.A.,…Taylor-Zapata, P. (2011). Dosing strategies for lithium monotherapy in children and adolescents with bipolar I disorder. J Child Adolesc Psychopharmacol, 21, 195–205. PMID: 21663422.

Findling, R.L., Landersdorfer, C.B., Kafantaris, V., Pavuluri, M., McNamara, N.K., McClellan, J.,…Jusko, W.J. (2010). First-dose pharmacokinetics of lithium carbonate in children and adolescents. J Clin Psychopharmacol, 30, 404–10. PMID: 20531219.

Findling, R.L., Frazier, J.A., Kafantaris, V., Kowatch, R., McClellan, J., Pavuluri, M.,…Taylor-Zapata P. (2008). The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. Child Adolesc Psychiatry Ment Health, 12, 21. doi:10.1186/1753-2000-2-21. PMID: 18700004.

LORAZEPAM

Gonzalez, D., Chamberlain, J.M., Guptill, J.T., Sullivan, J.E., Cohen‐Wolkowiez, M., Harper, B.,…Capparelli, E.V., Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2017) Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.  Clinical Pharmacokinet, 56(8), 941-951. PMCID: PMC5466505

Holsti, M., Zemek, R., Baren, J., Stanley, R.M., Mahajan, P., Vance, C,…Chamberlain, J.M. (2014). Variation of community consultation and public disclosure for a pediatric multi-centered ''Exception from Informed Consent'' trial. Clin Trials, 12, 67-76. Epub. PMID: 25369796.

Chamberlain, J.M., Okada, P., Holsti, M., Mahajan, P., Brown, K.M., Vance, C.,…Chamberlain, J.M. (2014). Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial. JAMA, 311, 1652-1660. doi:10.1001/jama.2014.2625. PMID: 24756515.

Chamberlain, J.M., Capparelli, E.V., Brown, K.M., Vance, C.W., Lillis, K., Mahajan, P.,…van den Anker, J., Pediatric Emergency Care Applied Research Network (PECARN). (2012). The pharmacokinetics of intravenous lorazepam in pediatric patients with and without status epilepticus. J Pediatr, 160, 667–672. PMID: 22050870.

Chamberlain, J.M., Lillis, K., Vance, C., Brown, K.M., Fawumi, O., Nichols, S.,…Baren, J.M., Pediatric Emergency Care Applied Research Network. (2009). Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups. Acad Emerg Med, 16, 763–770. PMID: 19673713.

MERCY TAPE STUDY

Abdel-Rahman, S., Paul, I., Delmore, P., James, L., Fearn, L., Atz, A.,…Smith, P.B., Best Pharmaceuticals for Children Act – Pediatric Trials Network. (2017) A Weight Estimation Strategy for Preterm and Full-Term Infants. Glob Pediatr Health, 4, 1-9.

Abdel-Rahman, S., Paul, I.M., James, L.P., & Lewandowski, A. (2013). Evaluation of the Mercy TAPE: performance against the standard for pediatric weight estimation. Ann Emerg Med, 62, 332-339. Doi:10.1016/j.annemergmed.2013.02.021. PMID: 23602655.

MEROPENEM

Ganguly, S., Edginton, A.N., Gerhart, J.G., Cohen-Wolkowiez, M., Greenberg, R.G., & Gonzalez, D. (2021). Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants. Clin Pharmacokinet, 60(12), 1591-1604. PMID: 34155614

Hornik, C.P., Herring, A.H., Benjamin, D.K. Jr., Capparelli, E.V., Kearns, G.L., van den Anker, J.,…Smith, P.B., Best Pharmaceuticals for Children Act-Pediatric Trials Network. (2013). Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants. Pediatr Infect Dis J, 32, 748-753. PMID: 23838776.

Cohen-Wolkowiez, M., Poindexter, B., Bidegain, M., Weitkamp, J.H., Schelonka, R.L., Randolph, D.A.,…Smith, P.B., Meropenem Study Team. (2012). Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clin Infect Dis, 55, 1495–1502. Epub 2012 Sep 5. PMID:22955430.

Smith, P.B., Cohen-Wolkowiez, M., Castro, L.M., Poindexter, B., Bidegan, M., Weitkamp, J.H.,…Benjamin, D.K., Jr., Meropenem Study Team. (2011). Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections. Pediatr Infect Dis J, 30, 844–849. PMID: 21829139.

METRONIDAZOLE

Wang, L.A., Gonzalez, D., Leeder, J.S., Tyndale, R.F., Pearce, R.E., Benjamin, D.K. Jr,…Cohen-Wolkowiez, M., Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee.(2016) Metronidazole Metabolism in Neonates and the Interplay between Ontogeny and Genetic Variation. J Clin Pharmacol, 57(2), 230-234. PMID: 27417511.

Sampson, M.R., Bloom, B.T., Arrieta, A., Capparelli, E., Benjamin, D.K. Jr, Smith, P.B.,…Cohen-Wolkowiez, M., Intestinal fatty-acid binding protein and metronidazole response in premature infants. (2014) J Neonatal Perinatal Med, 7(3), 223-228. PMCID: PMC4225165.

Cohen-Wolkowiez, M., Sampson, M., Bloom, B.T., Arrieta, A., Wynn, J.L., Martz, K.,…Smith, P.B., on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network. (2013) Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants. Pediatr Infect Dis J, 32(9), 956-961. PMCID: PMC3769518.

Cohen-Wolkowiez, M., Ouellet, D., Smith, P.B., James, L.P., Ross, A., Sullivan, J.E.,…Benjamin, D.K. Jr. (2012). Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants. Antimicrob Agents Chemother, 56, 1828–37. Doi: 10.1128/AAC.06071-11. Epub. PMID:22252819

MILRINONE

Samiee-Zafarghandy, S., Raman, S.R., van den Anker, J.N., McHutchison, K., Hornik, C.P., Clark, R.H., Brian, Smith, P., Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. (2015). Safety of milrinone use in neonatal intensive care units. Early Hum Dev, 91(1), 31-35. PMCID: PMC4302030.

OCTREOTIDE

Testoni, D., Hornik, C.P., Neely, M.L., Yang, Q., McMahon, A.W., Clark, R.H., Smith, P.B., Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee. (2015). Safety of octreotide in hospitalized infants. Early Hum Dev, 91(7), 387-392. PMC4450124.

ONCOLOGY STUDIES

Edwards, A.Y., Skolnick, J.M., Dombrowsky, E., Patel, D., & Barrett, J.S. (2012). Modeling and simulation approaches to evaluate pharmacokinetic sampling contamination from central venous catheters in pediatric pharmacokinetic studies of actinomycin-D: a report from the Children's Oncology Group. Cancer Chemother Pharmacol, 70, 83–94. Doi: 10.1007/s00280-012-1878-y. Epub. PMID: 22623208.

Langholz, B., Skolnik, J.M., Barrett, J.S., Renbarger, J., Seibel, N.L., Zajicek, A., & Arndt, C.A. (2011). Dactinomycin and vincristine toxicity in the treatment of childhood cancer: a retrospective study from the Children's Oncology Group. Pediatr Blood Cancer, 57, 252–257. PMID: 21671362.

Skolnik, J.M., Ahang, A.Y., Barrett, J.S., & Adamson, P.C. (2010). Approaches to clear residual chemotherapeutics form indwelling catheters in children with cancer. Ther Drug Monit, 32, 741–748. Doi:10.1097/FTD.0b013e3181fa3c68. PMID20962707.

Barrett, J.S., Jayaraman, B., Patel, D., & Skolnik, J.M. (2008). A SAS-based solution to evaluate study design efficiency of phase I pediatric oncology trials via discrete event simulation. Comput Methods Programs Biomed, 90, 240–250. PMID: 18276034.

Mondick, J.T., Gibiansky, L., Gastonguay, M.R., Skolnik, J.M., Cole, M., Veal, G.J.,…Barrett, J.S. (2008). Population pharmacokinetic investigation of actinomycin-D in children and young adults. J Clin Pharmacol, 48, 35-42. PMID: 18094218.

Skolnik, J.M., Barrett, J.S., Jayaraman, B., Patel, D., & Adamson, P.C. (2008). Shortening the timeline of pediatric phase I trials: the rolling six design. J Clin Oncol, 10, 190–195. Doi 10.1200/JCO.2007.12.7712. PMID: 18182661.

Lee, J.I., Skolnik, J.M., Barrett, J.S., & Adamson, P.C. (2007). A sensitive and selective liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of actinomycin-D and vincristine in children with cancer. J Mass Spectrom, 42, 761–770. PMID:17511020.

PANTOPRAZOLE

Shakhnovich, V., Smith, P.B., Guptill, J., James, L., Collier, D., Wu, H.,…Cohen-Wolkowiez, M., Best Pharmaceuticals for Children Act – Pediatric Trials Network (2018). A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents. Paediatr Drugs, 20(5), 483-495.PMID: 30097906.

Shakhnovich, V., Smith, P.B., Guptill, J., James, L., Collier, D., Wu, H.,…Kearns, G., Best Pharmaceuticals for Children Act – Pediatric Trials Network. (2018) Obese Children Require Lower Doses of Pantoprazole than Nonobese Peers to Achieve Equal Systematic Drug Exposures. J Pediatrics, 193, 102-108.

PIPERACILLIN

Salerno, S., Hornik, C.P., Cohen‐Wolkowiez, M., Smith, P.B., Ku, L.C., Kelly, M.S.,…Gonzalez, D., Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. (2017) Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin‐Tazobactam Safety in Infants. Pediatr Infect Dis J, 36(9), 855-859. PMC5555808.

RIFAMPIN

Smith, P.B., Cotton, C.M., Hudak, M.L., Sullivan, J.E., Poindexter, B.B., Cohen-Wolkowiez, M.,…Laughon, M.M., Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.(2019) Rifampin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother.  63(6). PMID: 30910891

Arnold, C.J., Ericson, J., Kohman, J., Corey, K.L., Oh, M., Onabanjo, J.,…Chu, V.H., on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee. (2015) Rifampin use and safety in hospitalized infants. Am J Perinatol, 32(6), 565-570. PMC4433596.

RISPERIDONE

Karatza, E., Ganguly, S., Hornik, C.D., Muller, W.J., Al-Uzri, A., James, L.,…Gonzalez, D. (2022). External Evaluation of Risperidone Population Pharmacokinetic Models Using Opportunistic Pediatric Data. Front Pharmacol. PMID: 35370711

SILDENAFIL

Jackson, W., Gonzalez, D., Smith, P.B., Ambalavanan, N., Atz, A.M., Sokol, G.M.,…Laughon, M.M. (2022). Safety of Sildenafil in extremely Premature Infants: A Phase I Trial. J. Perinatol. 42(1), 31-36. PMID: 34741102

Samiee-Zafarghandy, S., Van den Anker, J.N., Laughon, M.M., Clark, R.H., Smith, P.B., and Hornik, C.P., on behalf of the Best Pharmaceuticals for Children’s Act- Pediatric Trials Network Administrative Core Committee. (2016) Sildenafil and Retinopathy of Prematurity Risk in Very Low Birth Weight Infants. Am J Perinatol, 36(2), 137-140. PMC4731250.

SODIUM NITROPRUSSIDE

Spielberg, D.R., Barrett, J.S., Hammer, G.B., Drover, D.R., Reece, T., Cohane, C.A., & Schulman, S.R. (2014). Predictors of arterial blood pressure control during deliberate hypotension with sodium nitroprusside in children. Anesth Analg, 119, 867-874. PMID: 25099924.

Swezey, R., Shinn, W., Green, C., Drover, D.R., Hammer, G.B., Schulman, S.R.,…Boss, G.R.  (2013). Comparison of a new cobinamide-based method to a standard laboratory method for measuring cyanide in human blood. J Anal Toxicol, 37, 382-385. PMID: 23653045.

Hammer, G.B., Connolly, S.G., Schulman, S.R., Lewandowski, A., Cohane, C., Reece, T.L.,…Drover, D.R. (2013). Sodium nitroprusside is not associated with metabolic acidosis during intraoperative infusion in children. BMC Anesthesiology, 13. Doi:10.1186/1471-2253-13-9. PMID: 23631460.

TIMOLOL

Drolet, B.A., Boakye-Agyeman, F., Harper, B., Holland, K., Lewandowski A., Stefanko, N.,…Melloni C. (2020). Systemic Timolol Exposure Following Topical Application to Infantile Hemangiomas. J Am Acad Dermatol, 82(3), 733-736. PMID: 30790601

TRIMETHOPRIM

Wu., Y.S.S., Cohen-Wolkowiez, M., Hornik, C.P., Gerhart, J.G., Autmizguine, J. Cobbaert, M., Gonzalez, D. (2021). External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole. Antimicrob Agents Chemother, 65(7). PMID: 33903114

Gonzalez, D., Melloni, C., Poindexter, B.B., Yogev, R., Atz, A.M., Sullivan, J.E.,…Cohen-Wolkowiez, M., Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee (2015). Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis, 7(9), 1137-1149. PMC4455038.

PHARMACOLOGY-RELATED ARTICLES

Gerhart, J.G., Carreño, F.O., Edginton, A.N., Sinha, J., Perrin, E.M., Kumar, K.R.,…Gonzalez, D. (2022). Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling. Clin Pharmacokinet, 61(2), 307-320. PMID: 34617262

Gerhart, J.G., Carreño, F.O., Ford, J.L., Edginton, A.N., Perrin, E.M., Watt, K.M.,…Gonzalez, D. (2022). Use of Physiologically-Based Pharmacokinetic Modeling to Inform Dosing of the Opioid Analgesics Fentanyl and Methadone in Children with Obesity. CPT Pharmacometrics Syst Pharmacol. Epub ahead of print. PMID: 35491971

Maharaj, A.R., Gonzalez, D., Cohen-Wolkowiez, M., Hornik, C.P., Edginton, A.N. (2018). Improving Pediatric Protein Binding Estimates: An Evaluation of α1-Acid Glycoprotein Maturation in Healthy and Infected Subjects. Clin Pharmacokinet. PMID: 28779462.

Abdel-Rahman, S., Paul, I., Delmore, P., James, L., Fearn, L., Atz, A.,…Smith, P.B., Best Pharmaceuticals for Children Act – Pediatric Trials Network (2017). An Anthropometric Survey of U.S. Preterm and Full-Term Neonates. Ann Hum Biol, 44(8), 678-686. PMID: 29037091.

Lee, J.A., Sauer, B., Tuminski, W., Cheong, J., Fitz-Henley, J. 2nd, Mayers, M.,…Ericson, J.E., Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2016). Effectiveness of Granulocyte Colony-Stimulating Factor in Hospitalized Infants with Neutropenia. Am J Perinatol, 34(5), 458-464. PMID: 27649291.

Romaine, A., Ye, D., Ao, Z., Fang, F., Johnson, O., Riggs, B.,…Hornik, C.P., Best Pharmaceuticals for Children Act – Pediatric Trials Network (2016). Safety of histamine-2 receptor blockers in hospitalized VLBW infants. Early Hum Dev, 99, 27-30. PMC4969147.

England, A., Wade, K., Smith, P.B., Berezny, K., Laughon, M., on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. (2016). Optimizing Operational Efficiencies in Early Phase Trials: The Pediatric Trials Network Experience. Contemp Clin Trials, 47, 376-382. PMC4997801.

Rowe, S., Siegel, D., Benjamin, D.K. Jr., Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee. (2015). Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications. Clin Ther, 39(9), 1924-1932. PMC4586086.

Harskamp-van Ginkel, M.W., Hill, K.D., Becker, K., Testoni, D., Cohen-Wolkowiez, M., Gonzalez, D.,…Watt, K.M., for the Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee. (2015). Drug dosing and pharmacokinetics in children with obesity: a systematic review. JAMA Pediatr, 169(7), 678-685. PMC4494887.

Autmizguine, J., Hornik, C.P., Benjamin, D.K. Jr., Laughon, M.M., Clark, R.H., Cotton, C.M.,…Smith, P.B., Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. (2015). Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants. Pediatrics, 135(1), e117-e125. PMC4279070.

Cohen-Wolkowiez​, M., White, N.R., Bridges, A., Benjamin, D.K. Jr., & Kashuba, A.D. (2011). Development of a liquid chromatography-tandem mass spectrometry assay of six antimicrobials in plasma for pharmacokinetic studies in premature infants. J Chromatogr B Analyt Technol Biomed Life Sci, 879, 3497-3506. PMID: 21983195.

Laughon, M.M., Benjamin, D.K. Jr., Capparelli, E.V., Kearns, G.L., Berezny, K., Paul, I.M.,…Cohen-Wolkowiez, M. (2011). Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol, 4, 643–652. Doi:10.1586/ecp.11.43. Review. PMID:21980319.

Knight, L., Pahud, B.A., Scheffler, M., Euteneuer, J. C., Allen, C., Ross, J.,…Sullivan, J.E. (2022). Capacity Building in a New Clinical Trials Network through Inter-Network Collaboration. J. Pediatr, 240, 5-8. PMID: 33940019.

Adler, M.D., Krug, S., Eiger, C., Good, G.L., Kou, M., Nash, M.,…Donoghue, A.J. (2021). Impact of Personal Protective Equipment on the Performance of Emergency Pediatric Tasks. Pediatr Emerg Care.37(12), e1326-e1330. PMID: 32097378.

Puia-Dumitrescu, M., Younge, N., Benjamin, D.K., Lawson, K., Hume, C., Hill, K.,…Greenberg, R.G.; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network. (2020). Medications and In-hospital Outcomes in Infants Born at 22-24 Weeks Gestation. J Perinatol, 40(5), 781-789. PMID: 32066843

Taylor-Zapata, P., Baker-Smith, C.M., Burckart, G., Daniels, S.R., Flynn, J.T., Giacoia, G.,…Zajicek, A. (2019). Research Gaps in Primary Pediatric Hypertension. Pediatrics, 143 (5) e20183517; DOI: https://doi.org/10.1542/peds.2018-3517 external link

Ryan, R.M., Keller, R.L., Poindexter, B.B., D'Angio, C.T., Shaw, P.A., Bellamy, S.L.,…Greenberg, J.M., PROP Investigators. (2019). Respiratory Medications in Infants <29 Weeks during the First Year Postdischarge: The Prematurity and Respiratory Outcomes Program (PROP) Consortium. J Pediatr, 208:148-155.e3. doi: 10.1016/j.jpeds.2018.12.009. Epub 2019 Mar 8.

Fiks, A.G., Grundmeier, R.W., Steffes, J., Adams, W.G., Kaelber, D.C., Pace, W.D., & Wasserman, R.C., Comparative Effectiveness Research Through Collaborative Electronic Reporting (CER2) Consortium. (2015). Comparative effectiveness research through a collaborative electronic reporting consortium. Pediatrics, 136, e215-224. PMID: 26101357.

Zajicek, A., Fossler, M.J., Barrett, J.S., Worthington, J.H., Ternik, R. Charkoftaki, G.,…MacLaren, D.D. (2013). A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms. AAPS J, 15. PMID: 23907486.

Newth, C.J.L., Meert, K.L., Clark, A.E., Moler, F.W., Zuppa, A.F., Berg, R.A.,…Nicholson, C.E., Eunice Kennedy Shriver National Institutes of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. (2012). Fatal and near-fatal asthma in children: the critical care perspective. J Pediatr, 161, 214–221. PMID: 22494876.

Witt, K.L., Shelby, M.D., Itchon-Ramos, N., Faircloth, M., Kissling, G.E., Chrisman, A.K.,…Kollins, S.H. (2008). Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD. J Am Acad Child Adolesc Psychiatry, 47, 1375–1383. PMID: 18978633.

top of pageBACK TO TOP