Publications

Acyclovir

Sampson, M. R., Bloom, B. T., Lenfestey, R. W., Harper, B., Kashuba, A. D., Anand, R., Benjamin, D. K., Jr, Capparelli, E., Cohen-Wolkowiez, M., Smith, P. B., & Best Pharmaceuticals for Children Act–Pediatric Trials Network (2014). Population pharmacokinetics of intravenous acyclovir in preterm and term infants. The Pediatric Infectious Disease Journal, 33(1), 42–49. PMID: 24346595

Amiodarone

Dallefeld, S. H., Atz, A. M., Yogev, R., Sullivan, J. E., Al-Uzri, A., Mendley, S. R., Laughon, M., Hornik, C. P., Melloni, C., Harper, B., Lewandowski, A., Mitchell, J., Wu, H., Green, T. P., & Cohen-Wolkowiez, M. (2018). A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. Journal of Pharmacokinetics and Pharmacodynamics, 45(3), 419–430. PMID: 29435949

Ampicillin

Le, J., Greenberg, R. G., Yoo, Y., Clark, R. H., Benjamin, D. K., Jr, Zimmerman, K. O., Cohen-Wolkowiez, M., Wade, K. C., & Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee (2022). Ampicillin dosing in premature infants for early-onset sepsis: Exposure-driven efficacy, safety, and stewardship. Journal of Perinatology: Official Journal of the California Perinatal Association, 42(7), 959–964. PMID: 35210541

Le, J., Poindexter, B., Sullivan, J. E., Laughon, M., Delmore, P., Blackford, M., Yogev, R., James, L. P., Melloni, C., Harper, B., Mitchell, J., Benjamin, D. K., Jr, Boakye-Agyeman, F., & Cohen-Wolkowiez, M. (2018). Comparative analysis of ampicillin plasma and dried blood spot pharmacokinetics in neonates. Therapeutic Drug Monitoring, 40(1), 103–108. PMID: 29271816

Hornik, C. P., Benjamin, D. K., Jr, Smith, P. B., Pencina, M. J., Tremoulet, A. H., Capparelli, E. V., Ericson, J. E., Clark, R. H., 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. The Journal of Pediatrics, 178, 125–129.e1. PMID: 27522443

Tremoulet, A., Le, J., Poindexter, B., Sullivan, J. E., Laughon, M., Delmore, P., Salgado, A., Ian-U Chong, S., Melloni, C., Gao, J., Benjamin, D. K., Jr, Capparelli, E. V., Cohen-Wolkowiez, M., & 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. Antimicrobial Agents and Chemotherapy, 58(6), 3013–3020. PMID: 24614374

Azithromycin

Merchan, L. M., Hassan, H. E., Terrin, M. L., Waites, K. B., Kaufman, D. A., Ambalavanan, N., Donohue, P., Dulkerian, S. J., Schelonka, R., Magder, L. S., Shukla, S., Eddington, N. D., & Viscardi, R. M. (2015). Pharmacokinetics, microbial response, and pulmonary outcomes of multidose intravenous azithromycin in preterm infants at risk for ureaplasma respiratory colonization. Antimicrobial Agents and Chemotherapy, 59(1), 570–578. PMID: 25385115

Viscardi, R. M., Othman, A. A., Hassan, H. E., Eddington, N. D., Abebe, E., Terrin, M. L., Kaufman, D. A., & 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. Antimicrobial Agents and Chemotherapy, 57(5), 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. The Pediatric Infectious Disease Journal, 32(4), 394–398. PMID: 23114371

Hassan, H. E., Othman, A. A., Eddington, N. D., Duffy, L., Xiao, L., Waites, K. B., Kaufman, D. A., Fairchild, K. D., Terrin, M. L., & Viscardi, R. M. (2011). Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia. Journal of Clinical Pharmacology, 51(9), 1264–1275. PMID: 21098694

Baclofen

He, Y., Brunstrom-Hernandez, J. E., Thio, L. L., Lackey, S., Gaebler-Spira, D., Kuroda, M. M., Stashinko, E., Hoon, A. H., Jr, Vargus-Adams, J., Stevenson, R. D., Lowenhaupt, S., McLaughlin, J. F., Christensen, A., Dosa, N. P., Butler, M., Schwabe, A., Lopez, C., Roge, D., Kennedy, D., Tilton, A., … Jusko, W. J. (2014). Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy. The Journal of Pediatrics, 164(5), 1181–1188.e8. PMID: 24607242

Caffeine Citrate

Puia-Dumitrescu, M., Smith, P. B., Zhao, J., Soriano, A., Payne, E. H., Harper, B., Bendel-Stenzel, E., Moya, F., Chhabra, R., Ku, L., Laughon, M., 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. The Journal of Pediatrics, 211, 27–32.e1. PMID: 31101409

Cefepime

Arnold, C. J., Ericson, J., Cho, N., Tian, J., Wilson, S., Chu, V. H., Hornik, C. P., Clark, R. H., Benjamin, D. K., Jr, Smith, P. B., & Best Pharmaceuticals for Children Act--Pediatric Trials Network Administrative Core Committee (2015). Cefepime and ceftazidime safety in hospitalized infants. The Pediatric Infectious Disease Journal, 34(9), 964–968. PMID: 26376308

Clindamycin

Smith, M. J., Gonzalez, D., Goldman, J. L., Yogev, R., Sullivan, J. E., Reed, M. D., Anand, R., Martz, K., Berezny, K., Benjamin, D. K., Jr, Smith, P. B., Cohen-Wolkowiez, M., Watt, K., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2017). Pharmacokinetics of clindamycin in obese and nonobese children. Antimicrobial Agents and Chemotherapy, 61(4), e02014-16. PMID: 28137820

Gonzalez, D., Delmore, P., Bloom, B. T., Cotten, C. M., Poindexter, B. B., McGowan, E., Shattuck, K., Bradford, K. K., Smith, P. B., Cohen-Wolkowiez, M., Morris, M., Yin, W., Benjamin, D. K., Jr, & Laughon, M. M. (2016). Clindamycin pharmacokinetics and safety in preterm and term infants. Antimicrobial Agents and Chemotherapy, 60(5), 2888–2894. PMID: 26926644

Gonzalez, D., Melloni, C., Yogev, R., Poindexter, B. B., Mendley, S. R., Delmore, P., Sullivan, J. E., Autmizguine, J., Lewandowski, A., Harper, B., Watt, K. M., Lewis, K. C., Capparelli, E. V., Benjamin, D. K., Jr, Cohen-Wolkowiez, M., & Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee (2014). Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clinical Pharmacology and Therapeutics, 96(4), 429–437. PMID: 24949994

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. The Journal of Pediatrics, 183, 26–30.e3. PMID: 28108103

Dopamine

Batton, B. J., Li, L., Newman, N. S., Das, A., Watterberg, K. L., Yoder, B. A., Faix, R. G., Laughon, M. M., Van Meurs, K. P., Carlo, W. A., Higgins, R. D., 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. The Journal of Pediatrics, 161(1), 65–9.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. Pediatric Cardiology, 38(1), 155–161. PMID: 27826711

Erythromycin

Ericson, J. E., Arnold, C., Cheeseman, J., Cho, J., Kaneko, S., Wilson, E., Clark, R. H., Benjamin, D. K., Jr, Chu, V., Smith, P. B., 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. Journal of Pediatric Gastroenterology and Nutrition, 61(3), 334–339. PMID: 25806675

Fluconazole

Ericson, J. E., Kaufman, D. A., Kicklighter, S. D., Bhatia, J., Testoni, D., Gao, J., Smith, P. B., Prather, K. O., Benjamin, D. K., Jr, Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committeea, & Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee (2016). Fluconazole prophylaxis for the prevention of candidiasis in premature infants: A meta-analysis using patient-level data. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 63(5), 604–610. PMID: 27298330

Benjamin, D. K., Jr, Hudak, M. L., Duara, S., Randolph, D. A., Bidegain, M., Mundakel, G. T., Natarajan, G., Burchfield, D. J., White, R. D., Shattuck, K. E., Neu, N., Bendel, C. M., Kim, M. R., Finer, N. N., Stewart, D. L., Arrieta, A. C., Wade, K. C., Kaufman, D. A., Manzoni, P., Prather, K. O., … Fluconazole Prophylaxis Study Team (2014). Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: A randomized clinical trial. JAMA, 311(17), 1742–1749. PMID: 24794367

Piper, L., Smith, P. B., Hornik, C. P., Cheifetz, I. M., Barrett, J. S., Moorthy, G., Hope, W. W., Wade, K. C., Cohen-Wolkowiez, M., & Benjamin, D. K., Jr (2011). Fluconazole loading dose pharmacokinetics and safety in infants. The Pediatric Infectious Disease Journal, 30(5), 375–378. PMID: 21085048

Furosemide

Greenberg, R. G., Gayam, S., Savage, D., Tong, A., Gorham, D., Sholomon, A., Clark, R. H., Benjamin, D. K., Laughon, M., Smith, P. B., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2019). Furosemide exposure and prevention of bronchopulmonary dysplasia in premature infants. The Journal of Pediatrics, 208, 138-140. PMID: 30579586

Hydroxyurea

Estepp, J. H., Melloni, C., Thornburg, C. D., Wiczling, P., Rogers, Z., Rothman, J. A., Green, N. S., Liem, R., Brandow, A. M., Crary, S. E., Howard, T. H., Morris, M. H., Lewandowski, A., Garg, U., Jusko, W. J., 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. Journal of Clinical Pharmacology, 56(3), 298–306. PMID: 26201504

Wang, W. C., Ware, R. E., Miller, S. T., Iyer, R. V., Casella, J. F., Minniti, C. P., Rana, S., Thornburg, C. D., Rogers, Z. R., Kalpatthi, R. V., Barredo, J. C., Brown, R. C., Sarnaik, S. A., Howard, T. H., Wynn, L. W., Kutlar, A., Armstrong, F. D., Files, B. A., Goldsmith, J. C., Waclawiw, M. A., … BABY HUG investigators (2011). Hydroxycarbamide in very young children with sickle-cell anaemia: A multicentre, randomised, controlled trial (BABY HUG). Lancet (London, England), 377(9778), 1663–1672. PMID: 21571150

Rogers, Z. R., Wang, W. C., Luo, Z., Iyer, R. V., Shalaby-Rana, E., Dertinger, S. D., Shulkin, B. L., Miller, J. H., Files, B., Lane, P. A., Thompson, B. W., Miller, S. T., 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(9), 2614–2617. PMID: 21217080

Ketamine

Shi, Q., Guo, L., Patterson, T. A., Dial, S., Li, Q., Sadovova, N., Zhang, X., Hanig, J. P., Paule, M. G., Slikker, W., Jr, & Wang, C. (2010). Gene expression profiling in the developing rat brain exposed to ketamine. Neuroscience, 166(3), 852–863. PMID: 20080153

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., & Pediatric Trial Network Steering Committee (2018). Population pharmacokinetics of intramuscular and intravenous ketamine in children. Journal of Clinical Pharmacology, 58(8), 1092–1104. PMID: 29677389

Lisinopril

Trachtman, H., Frymoyer, A., Lewandowski, A., Greenbaum, L. A., Feig, D. I., Gipson, D. S., Warady, B. A., Goebel, J. W., Schwartz, G. J., Lewis, K., Anand, R., 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 Pharmacology and Therapeutics, 98(1), 25–33. PMID: 25807932

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. Clinical Pharmacokinetics, 56(1), 77–90. PMID: 27393139

Findling, R. L., Robb, A., McNamara, N. K., Pavuluri, M. N., Kafantaris, V., Scheffer, R., Frazier, J. A., Rynn, M., DelBello, M., Kowatch, R. A., Rowles, B. M., Lingler, J., Martz, K., Anand, R., Clemons, T. E., & Taylor-Zapata, P. (2015). Lithium in the acute treatment of bipolar I disorder: A double-blind, placebo-controlled study. Pediatrics, 136(5), 885–894. PMID: 26459650

Findling, R. L., Kafantaris, V., Pavuluri, M., McNamara, N. K., Frazier, J. A., Sikich, L., Kowatch, R., Rowles, B. M., Clemons, T. E., & Taylor-Zapata, P. (2013). Post-acute effectiveness of lithium in pediatric bipolar I disorder. Journal of Child and Adolescent Psychopharmacology, 23(2), 80–90. PMID: 23510444

Findling, R. L., Kafantaris, V., Pavuluri, M., McNamara, N. K., McClellan, J., Frazier, J. A., Sikich, L., Kowatch, R., Lingler, J., Faber, J., Rowles, B. M., Clemons, T. E., & Taylor-Zapata, P. (2011). Dosing strategies for lithium monotherapy in children and adolescents with bipolar I disorder. Journal of Child and Adolescent Psychopharmacology, 21(3), 195–205. PMID: 21663422

Findling, R. L., Landersdorfer, C. B., Kafantaris, V., Pavuluri, M., McNamara, N. K., McClellan, J., Frazier, J. A., Sikich, L., Kowatch, R., Lingler, J., Faber, J., Taylor-Zapata, P., & Jusko, W. J. (2010). First-dose pharmacokinetics of lithium carbonate in children and adolescents. Journal of Clinical Psychopharmacology, 30(4), 404–410. PMID: 20531219

Findling, R. L., Frazier, J. A., Kafantaris, V., Kowatch, R., McClellan, J., Pavuluri, M., Sikich, L., Hlastala, S., Hooper, S. R., Demeter, C. A., Bedoya, D., Brownstein, B., & Taylor-Zapata, P. (2008). The Collaborative Lithium Trials (CoLT): Specific aims, methods, and implementation. Child and Adolescent Psychiatry and Mental Health, 2(1), 21. PMID: 18700004

Lorazepam

Gonzalez, D., Chamberlain, J. M., Guptill, J. T., Cohen-Wolkowiez, M., Harper, B., Zhao, J., 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 Pharmacokinetics, 56(8), 941–951. PMID: 27943220

Holsti, M., Zemek, R., Baren, J., Stanley, R. M., Mahajan, P., Vance, C., Brown, K. M., Gonzalez, V., King, D., Jacobsen, K., Shreve, K., van de Bruinhorst, K., Jones, A. M., & Chamberlain, J. M. (2015). Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial. Clinical Trials (London, England), 12(1), 67–76. PMID: 25369796

Chamberlain, J. M., Okada, P., Holsti, M., Mahajan, P., Brown, K. M., Vance, C., Gonzalez, V., Lichenstein, R., Stanley, R., Brousseau, D. C., Grubenhoff, J., Zemek, R., Johnson, D. W., Clemons, T. E., Baren, J., & Pediatric Emergency Care Applied Research Network (PECARN) (2014). Lorazepam vs diazepam for pediatric status epilepticus: A randomized clinical trial. JAMA, 311(16), 1652–1660. PMID: 24756515

Chamberlain, J. M., Capparelli, E. V., Brown, K. M., Vance, C. W., Lillis, K., Mahajan, P., Lichenstein, R., Stanley, R. M., Davis, C. O., Gordon, S., Baren, J. M., van den Anker, J. N., & Pediatric Emergency Care Applied Research Network (PECARN) (2012). Pharmacokinetics of intravenous lorazepam in pediatric patients with and without status epilepticus. The Journal of Pediatrics, 160(4), 667–672.e2. PMID: 22050870

Chamberlain, J. M., Lillis, K., Vance, C., Brown, K. M., Fawumi, O., Nichols, S., Davis, C. O., Singh, T., 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. Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine, 16(8), 763–770. PMID: 19673713

Mercy Tape Study

Abdel-Rahman, S. M., Paul, I. M., Delmore, P., James, L., Fearn, L., Atz, A., Poindexter, B., Al-Uzri, A., Lewandowski, A., Harper, B., & Smith, P. B. (2017). A weight estimation strategy for preterm and full-term infants. Global Pediatric Health, 4, 1-9. PMID: 29308426

Abdel-Rahman, S. M., Paul, I. M., James, L. P., Lewandowski, A., & Best Pharmaceuticals for Children Act-Pediatric Trials Network (2013). Evaluation of the Mercy TAPE: Performance against the standard for pediatric weight estimation. Annals of Emergency Medicine, 62(4), 332–339.e6. PMID: 23602655

Meropenem

Ganguly, S., Edginton, A. N., Gerhart, J. G., Cohen-Wolkowiez, M., Greenberg, R. G., Gonzalez, D., & Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee (2021). Physiologically-based pharmacokinetic modeling of meropenem in preterm and term infants. Clinical Pharmacokinetics, 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., Cohen-Wolkowiez, M., Clark, R. H., 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. The Pediatric Infectious Disease Journal, 32(7), 748–753. PMID: 23838776

Cohen-Wolkowiez, M., Poindexter, B., Bidegain, M., Weitkamp, J. H., Schelonka, R. L., Randolph, D. A., Ward, R. M., Wade, K., Valencia, G., Burchfield, D., Arrieta, A., Mehta, V., Walsh, M., Kantak, A., Rasmussen, M., Sullivan, J. E., Finer, N., Rich, W., Brozanski, B. S., van den Anker, J., … Meropenem Study Team (2012). Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 55(11), 1495–1502. PMID: 22955430

Smith, P. B., Cohen-Wolkowiez, M., Castro, L. M., Poindexter, B., Bidegain, M., Weitkamp, J. H., Schelonka, R. L., Ward, R. M., Wade, K., Valencia, G., Burchfield, D., Arrieta, A., Bhatt-Mehta, V., Walsh, M., Kantak, A., Rasmussen, M., Sullivan, J. E., Finer, N., Brozanski, B. S., Sanchez, P., … Meropenem Study Team (2011). Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections. The Pediatric Infectious Disease Journal, 30(10), 844–849. PMID: 21829139

Metronidazole

Wang, L. A., Gonzalez, D., Leeder, J. S., Tyndale, R. F., Pearce, R. E., Benjamin, D. K., Jr, Kearns, G. L., Cohen-Wolkowiez, M., & Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee (2017). Metronidazole metabolism in neonates and the interplay between ontogeny and genetic variation. Journal of Clinical Pharmacology, 57(2), 230–234. PMID: 27417511

Sampson, M. R., Bloom, B. T., Arrieta, A., Capparelli, E., Benjamin, D. K., Jr, Smith, P. B., Kearns, G. L., van den Anker, J., & Cohen-Wolkowiez, M. (2014). Intestinal fatty-acid binding protein and metronidazole response in premature infants. Journal of Neonatal-Perinatal Medicine, 7(3), 223–228. PMID: 25318626

Cohen-Wolkowiez, M., Sampson, M., Bloom, B. T., Arrieta, A., Wynn, J. L., Martz, K., Harper, B., Kearns, G. L., Capparelli, E. V., Siegel, D., Benjamin, D. K., Jr, Smith, P. B., & 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. The Pediatric Infectious Disease Journal, 32(9), 956–961. PMID: 23587979

Cohen-Wolkowiez, M., Ouellet, D., Smith, P. B., James, L. P., Ross, A., Sullivan, J. E., Walsh, M. C., Zadell, A., Newman, N., White, N. R., Kashuba, A. D., & Benjamin, D. K., Jr (2012). Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants. Antimicrobial Agents and Chemotherapy, 56(4), 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 Human Development, 91(1), 31–35. PMID: 25460254

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 Human Development, 91(7), 387–392. PMID: 25968047

Oncology Studies

Edwards, A. Y., Skolnik, 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 Chemotherapy and Pharmacology, 70(1), 83–94. 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. Pediatric Blood & Cancer, 57(2), 252–257. PMID: 21671362

Skolnik, J. M., Zhang, A. Y., Barrett, J. S., & Adamson, P. C. (2010). Approaches to clear residual chemotherapeutics from indwelling catheters in children with cancer. Therapeutic Drug Monitoring, 32(6), 741–748. PMID: 20962707

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. Computer Methods and Programs in Biomedicine, 90(3), 240–250. PMID: 18276034

Mondick, J. T., Gibiansky, L., Gastonguay, M. R., Skolnik, J. M., Cole, M., Veal, G. J., Boddy, A. V., Adamson, P. C., & Barrett, J. S. (2008). Population pharmacokinetic investigation of actinomycin-D in children and young adults. Journal of Clinical Pharmacology, 48(1), 35–42. PMID: 18094218

Pantoprazole

Shakhnovich, V., Brian Smith, P., Guptill, J. T., James, L. P., Collier, D. N., Wu, H., Livingston, C. E., Zhao, J., Kearns, G. L., 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. Paediatric Drugs, 20(5), 483–495. PMID: 30097906

Shakhnovich, V., Smith, P. B., Guptill, J. T., James, L. P., Collier, D. N., Wu, H., Livingston, C. E., Zhao, J., Kearns, G. L., & Best Pharmaceuticals for Children Act – Pediatric Trials Network (2018). Obese children require lower doses of pantoprazole than nonobese peers to achieve equal systemic drug exposures. The Journal of Pediatrics, 193, 102–108.e1. PMID: 29389444

Piperacillin

Salerno, S., Hornik, C. P., Cohen-Wolkowiez, M., Smith, P. B., Ku, L. C., Kelly, M. S., Clark, R., 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. The Pediatric Infectious Disease Journal, 36(9), 855–859. PMID: 28410277

Rifampin

Smith, P. B., Cotten, C. M., Hudak, M. L., Sullivan, J. E., Poindexter, B. B., Cohen-Wolkowiez, M., Boakye-Agyeman, F., Lewandowski, A., Anand, R., Benjamin, D. K., Jr, Laughon, M. M., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2019). Rifampin pharmacokinetics and safety in preterm and term infants. Antimicrobial Agents and Chemotherapy, 63(6), e00284-19. PMID: 30910891

Arnold, C. J., Ericson, J., Kohman, J., Corey, K. L., Oh, M., Onabanjo, J., Hornik, C. P., Clark, R. H., Benjamin, D. K., Jr, Smith, P. B., Chu, V. H., & Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee (2015). Rifampin use and safety in hospitalized infants. American Journal of Perinatology, 32(6), 565–570. PMID: 25594217

Risperidone

Karatza, E., Ganguly, S., Hornik, C. D., Muller, W. J., Al-Uzri, A., James, L., Balevic, S. J., & Gonzalez, D. (2022). External evaluation of risperidone population pharmacokinetic models using opportunistic pediatric data. Frontiers in Pharmacology, 13, 817276. PMID: 35370711

Sildenafil

Jackson, W., Gonzalez, D., Smith, P. B., Ambalavanan, N., Atz, A. M., Sokol, G. M., Hornik, C. D., Stewart, D., Mundakel, G., Poindexter, B. B., Ahlfeld, S. K., Mills, M., Cohen-Wolkowiez, M., Martz, K., Hornik, C. P., Laughon, M. M., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2022). Safety of sildenafil in extremely premature infants: A phase I trial. Journal of Perinatology: Official Journal of the California Perinatal Association, 42(1), 31–36. PMID: 34741102

Samiee-Zafarghandy, S., van den Anker, J. N., Laughon, M. M., Clark, R. H., Smith, P. B., Hornik, C. P., & Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee (2016). Sildenafil and retinopathy of prematurity risk in very low birth weight infants. Journal of Perinatology: Official Journal of the California Perinatal Association, 36(2), 137–140. PMID: 26491852

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. Anesthesia and Analgesia, 119(4), 867–874. PMID: 25099924

Swezey, R., Shinn, W., Green, C., Drover, D. R., Hammer, G. B., Schulman, S. R., Zajicek, A., Jett, D. A., & Boss, G. R. (2013). Comparison of a new cobinamide-based method to a standard laboratory method for measuring cyanide in human blood. Journal of Analytical Toxicology, 37(6), 382–385. PMID: 23653045

Hammer, G. B., Connolly, S. G., Schulman, S. R., Lewandowski, A., Cohane, C., Reece, T. L., Anand, R., Mitchell, J., & Drover, D. R. (2013). Sodium nitroprusside is not associated with metabolic acidosis during intraoperative infusion in children. BMC Anesthesiology, 13, 9. PMID: 23631460

Timolol

Drolet, B. A., Boakye-Agyeman, F., Harper, B., Holland, K., Lewandowski, A., Stefanko, N., Melloni, C., & Pediatric Trials Network Steering Committee. (2020). Systemic timolol exposure following topical application to infantile hemangiomas. Journal of the American Academy of Dermatology, 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., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2021). External evaluation of two pediatric population pharmacokinetics models of oral trimethoprim and sulfamethoxazole. Antimicrobial Agents and Chemotherapy, 65(7), e0214920. PMID: 33903114

Gonzalez, D., Melloni, C., Poindexter, B. B., Yogev, R., Atz, A. M., Sullivan, J. E., Mendley, S. R., Delmore, P., Delinsky, A., Zimmerman, K., Lewandowski, A.,er, B., Lewis, K. C., Benjamin, D. K., Jr, 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. PMID: 26039810 Harp

Job, K. M., Dallmann, A., Parry, S., Saade, G., Haas, D., Hughes, B., Berens, P., Chen, J. Y., Fu, C., Humphrey, K., Hornik, C., Balevic, S., Zimmerman, K., & Watt, K. (2022). Development of a generic physiologically-based pharmacokinetic model for lactation and prediction of maternal and infant exposure to ondansetron via breast milk. Clinical Pharmacology and Therapeutics, 111(5), 1111-1120. PMID: 35076931

Eisenstein, E. L., Zozus, M. N., Garza, M. Y., Lanham, H. J., Adagarla, B., Walden, A., Benjamin, D. K., Zimmerman, K. O., Kumar, K. R., & Best Pharmaceuticals for Children Act–Pediatric Trials Network (2023). Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection. Contemporary Clinical Trials, 128, 107-144. PMID: 36898625 

Knight, L., Pahud, B. A., Scheffler, M., Euteneuer, J. C., Allen, C., Ross, J., Ali, W., Meyer, M., Purohit, P. J., Zimmerman, K. O., Sullivan, J. E., & Environmental Influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (2022). Capacity building in a new clinical trials network through inter-network collaboration. The Journal of Pediatrics, 240, 5–8. PMID: 33940019

Gerhart, J. G., Carreño, F. O., Edginton, A. N., Sinha, J., Perrin, E. M., Kumar, K. R., Rikhi, A., Hornik, C. P., Harris, V., Ganguly, S., Cohen-Wolkowiez, M., Gonzalez, D., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2022). Development and evaluation of a virtual population of children with obesity for physiologically based pharmacokinetic modeling. Clinical Pharmacokinetics, 61(2), 307–320. PMID: 34617262

Gerhart, J. G., Carreño, F. O., Ford, J. L., Edginton, A. N., Perrin, E. M., Watt, K. M., Muller, W. J., Atz, A. M., Al-Uzri, A., Delmore, P., Gonzalez, D., & Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee (2022). Use of physiologically-based pharmacokinetic modeling to inform dosing of the opioid analgesics fentanyl and methadone in children with obesity. CPT: Pharmacometrics & Systems Pharmacology, 11(6), 778–791. PMID: 35491971

Adler, M. D., Krug, S., Eiger, C., Good, G. L., Kou, M., Nash, M., Henretig, F. M., Hornik, C. P., Gosnell, L., Chen, J. Y., Debski, J., Sharma, G., Siegel, D., Donoghue, A. J., & Best Pharmaceuticals for Children Act–Pediatric Trials Network (2021). Impact of personal protective equipment on the performance of emergency pediatric tasks. Pediatric Emergency Care, 37(12), e1326–e1330. PMID: 32097378

Puia-Dumitrescu, M., Younge, N., Benjamin, D. K., Lawson, K., Hume, C., Hill, K., Mengistu, J., Wilson, A., Zimmerman, K. O., Ahmad, K., & Greenberg, R. G. (2020). Medications and in-hospital outcomes in infants born at 22-24 weeks of gestation. Journal of Perinatology: Official Journal of the California Perinatal Association, 40(5), 781–789. PMID: 32066843

Zimmerman, K. O., Benjamin, D. K.  Jr, Becker, M. L., Anand,  R., & Hornik,  C. P. (2019). Product labeling of drugs commonly administered to children and adults with obesity. Pharmaceutical Regulatory Affairs: Open Access, 8(1), 219. PMID: 37220561

Hornik, C. P., Atz, A. M., Bendel, C., Chan, F., Downes, K., Grundmeier, R., Fogel, B., Gipson, D., Laughon, M., Miller, M., Smith, M., Livingston, C., Kluchar, C., Heath, A., Jarrett, C., McKerlie, B., Patel, H., Hunter, C. & Best Pharmaceuticals for Children Act—Pediatric Trials Network (2019). Creation of a multicenter pediatric inpatient data repository derived from electronic health records. Applied Clinical Informatics, 10(2), 307-315. PMID: 31067576

Taylor-Zapata, P., Baker-Smith, C. M., Burckart, G., Daniels, S. R., Flynn, J. T., Giacoia, G., Green, D., Kelly, A. S., Khurana, M., Li, J. S., Pratt, C., Urbina, E. M., & Zajicek, A. (2019). Research gaps in primary pediatric hypertension. Pediatrics, 143(5), e20183517. PMID: 31023830

Ryan, R. M., Keller, R. L., Poindexter, B. B., D'Angio, C. T., Shaw, P. A., Bellamy, S. L., Moore, P. E., McPherson, C., 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. The Journal of Pediatrics, 208, 148–155.e3. PMID: 30857774

Balevic, S. J. & Cohen-Wolkowiez, M. (2018). Innovative study designs optimizing clinical pharmacology research in infants and children. Journal Of Clinical Pharmacology, 58 Suppl 10. PMID: 30248192

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. Clinical Pharmacokinetics, 57(5), 577–589. PMID: 28779462

Abdel-Rahman, S. M., Paul, I. M., Delmore, P., James, L., Fearn, L., Atz, A. M., Poindexter, B. B., Al-Uzri, A., Lewandowski, A., Harper, B. L., Smith, P. B., & Best Pharmaceuticals for Children Act—Pediatric Trials Network (2017). An anthropometric survey of U.S. pre-term and full-term neonates. Annals of Human Biology, 44(8), 678–686. PMID: 29037091

Lee, J. A., Sauer, B., Tuminski, W., Cheong, J., Fitz-Henley, J., 2nd, Mayers, M., Ezuma-Igwe, C., Arnold, C., Hornik, C. P., Clark, R. H., Benjamin, D. K., Jr, Smith, P. B., Ericson, J. E., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee (2017). Effectiveness of granulocyte colony-stimulating factor in hospitalized infants with neutropenia. American Journal of Perinatology, 34(5), 458–464. PMID: 27649291

Romaine, A., Ye, D., Ao, Z., Fang, F., Johnson, O., Blake, T., Benjamin, D. K., Jr, Cotten, C. M., Testoni, D., Clark, R. H., Chu, V. H., Smith, P. B., Hornik, C. P., & Best Pharmaceuticals for Children Act – Pediatric Trials Network (2016). Safety of histamine-2 receptor blockers in hospitalized VLBW infants. Early Human Development, 99, 27–30. PMID: 27390109

England, A., Wade, K., Smith, P. B., Berezny, K., Laughon, M., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee (2016). Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience. Contemporary Clinical Trials, 47, 376–382. PMID: 26968616

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. Clinical Therapeutics, 37(9), 1924–1932. PMID: 26323523

Harskamp-van Ginkel, M. W., Hill, K. D., Becker, K. C., Testoni, D., Cohen-Wolkowiez, M., Gonzalez, D., Barrett, J. S., Benjamin, D. K., Jr, Siegel, D. A., Banks, P., Watt, K. M., & Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee (2015). Drug dosing and pharmacokinetics in children with obesity: A systematic review. JAMA Pediatrics, 169(7), 678–685. PMID: 25961828

Autmizguine, J., Hornik, C. P., Benjamin, D. K., Jr, Laughon, M. M., Clark, R. H., Cotten, C. M., Cohen-Wolkowiez, M., Benjamin, D. K., 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. PMID: 25511117

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(1), e215–e224. PMID: 26101357

Zajicek, A., Fossler, M. J., Barrett, J. S., Worthington, J. H., Ternik, R., Charkoftaki, G., Lum, S., Breitkreutz, J., Baltezor, M., Macheras, P., Khan, M., Agharkar, S., & MacLaren, D. D. (2013). A report from the pediatric formulations task force: Perspectives on the state of child-friendly oral dosage forms. The AAPS Journal, 15(4), 1072–1081. PMID: 23907486

Newth, C. J., Meert, K. L., Clark, A. E., Moler, F. W., Zuppa, A. F., Berg, R. A., Pollack, M. M., Sward, K. A., Berger, J. T., Wessel, D. L., Harrison, R. E., Reardon, J., Carcillo, J. A., Shanley, T. P., Holubkov, R., Dean, J. M., Doctor, A., Nicholson, C. E., & Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (2012). Fatal and near-fatal asthma in children: The critical care perspective. The Journal of Pediatrics, 161(2), 214–21.e3. PMID: 22494876

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. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 879(30), 3497–3506. PMID: 21983195

Laughon, M. M., Benjamin, D. K., Jr, Capparelli, E. V., Kearns, G. L., Berezny, K., Paul, I. M., Wade, K., Barrett, J., Smith, P. B., & Cohen-Wolkowiez, M. (2011). Innovative clinical trial design for pediatric therapeutics. Expert Review of Clinical Pharmacology, 4(5), 643–652. PMID: 21980319

Witt, K. L., Shelby, M. D., Itchon-Ramos, N., Faircloth, M., Kissling, G. E., Chrisman, A. K., Ravi, H., Murli, H., Mattison, D. R., & Kollins, S. H. (2008). Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 47(12), 1375–1383. PMID: 18978633

Asthma Therapeutics Working Group

• Szefler, S. J., Chmiel, J. F., Fitzpatrick, A. M., Giacoia, G., Green, T. P., Jackson, D. J., Nielsen, H. C., Phipatanakul, W., & Raissy, H. H. (2014). Asthma across the ages: Knowledge gaps in childhood asthma. The Journal of Allergy and Clinical Immunology, 133(1), 3–14. PMID: 24290281
• Asthma Across the Ages: Knowledge Gaps in Childhood Asthma (PDF 384 KB)
  January 23, 2014; presented by Stanley Szefler, M.D. of Children's Hospital Colorado
• Roundtable Discussion Feedback (PDF 279 KB)

Diabetes Therapeutics Working Group

Tamborlane, W. V., Haymond, M. W., Dunger, D., Shankar, R., Gubitosi-Klug, R., Bethin, K., Karres, J., Tomasi, P., Libman, I., Hale, P. H., Portman, R., Klingensmith, G., Reed, M., Blumer, J., Giacoia, G., & NICHD Diabetes Working Group (2016). Expanding treatment options for youth with type 2 diabetes: Current problems and proposed solutions: A white paper From the NICHD Diabetes Working Group. Diabetes Care, 39(3), 323–329. PMID: 26908928

Ontogeny of Transporters in Children Working Group

Brouwer, K. L., Aleksunes, L. M., Brandys, B., Giacoia, G. P., Knipp, G., Lukacova, V., Meibohm, B., Nigam, S. K., Rieder, M., de Wildt, S. N., & Pediatric Transporter Working Group (2015). Human ontogeny of drug transporters: Review and recommendations of the Pediatric Transporter Working Group. Clinical Pharmacology and Therapeutics, 98(3), 266–287. PMID: 26088472