Adults

Physiologically-Based Pharmacokinetic Modeling Characterizes the CYP3A-Mediated Drug-Drug Interaction Between Fluconazole and Sildenafil in Infants

Posted on by Kayla Korzekwinski

Clinical Pharmacology & Therapeutics • January 2021

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Salerno SN, Edginton A, Gerhart JG, Laughon MM, Ambalavanan N, Sokol GM, Hornik CD, Stewart D, Mills M, Martz K, Gonzalez D; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee
Infants being treated for pulmonary hypertension and prevention or treatment of invasive candidiasis may be given sildenafil with fluconazole concurrently. Physiologically-based pharmacokinetic (PBPK) modeling can potentially predict pediatric drug-drug interactions (DDIs) when clinical DDI data are limited. This study highlights the feasibility of PBPK modeling to predict DDIs in infants and the need to include CYP3A7 parameters.

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • April 2019

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Balevic SJ, Green TP, Clowse MEB, Eudy AM, Schanberg LE, Cohen-Wolkowiez M

 Hydroxychloroquine is an oral drug prescribed to pregnant women with rheumatic disease to reduce disease activity and prevent flares. Physiologic changes during pregnancy may substantially alter drug pharmacokinetics. However, the effect of pregnancy on hydroxychloroquine disposition and the potential need for dose adjustment remains virtually unknown. This study developed a one-compartment population-pharmacokinetic model for hydroxychloroquine in pregnant women with rheumatic disease.

Predictors of Prolonged Breast Milk Provision to Very Low Birth Weight Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • November 2018

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Romaine A, Clark RH, Davis B, Hendershot K, Kite V, Laughon M, Updike I, Miranda ML, Meier PP, Patel AL, Smith PB, Cotton CM, Benjamin DK Jr, Greenberg RG

This study identified factors associated with prolonged maternal breast milk (BM) provision in very low birth weight (VLBW) infants. Results suggest that maternal-infant demographic and clinical factors and household neighborhood socioeconomic characteristics were associated with provision of maternal BM at 30 postnatal days to VLBW infants. Identification of these factors allows providers to anticipate mothers’ needs and develop tailored interventions designed to improve rates of prolonged maternal BM provision and infant outcomes.

Risk factors for group B streptococcal disease in neonates of mothers with negative antenatal testing

Posted on by Kayla Korzekwinski

Journal of Perinatology • February 2017

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Parente V, Clark RH, Ku L, Fennell C, Johnson M, Morris E, Romaine A, Benjamin DK, Smith PB, Greenberg R

The aim of this study was to identify risk factors for early-onset group B Streptococcus (EOGBS) disease in neonates of mothers with negative antenatal screening. Maternal age <18 years and black race were the strongest predictors of EOGBS. Further research investigating contributors to the discordance between screening results and neonatal outcomes in these populations is needed.

Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients

Posted on by Kayla Korzekwinski

Therapeutic Drug Monitoring • October 2016

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Zimmerman K, Wu H, Greenberg R, Hill K, Patel U, Ku L, Gonzalez D, Hornik C, Melloni C, Cohen-Wolkowiez M

Sirolimus, an immunosuppressive agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (the ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants is necessary to optimize the care of patients and set standards for bioequivalence evaluation of sirolimus products. However, the therapeutic index for sirolimus has been inconsistently defined. Use of therapeutic drug monitoring results and PK modeling permitted correlation of sirolimus concentrations with graft loss or rejection and decline in renal function.

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval

Posted on by Kayla Korzekwinski

Clinical Therapeutics • September 2016

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Zimmerman K, Putera M, Hornik CP, Smith PB, Benjamin DK Jr, Mulugeta Y, Burckart GJ, Cohen-Wolkowiez M, Gonzalez D

We sought to determine the extent of exposure matching, defined by a comparison of area under the concentration-time curve, between children and adults, for anti-infective drug products submitted to the FDA for approval.

Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots

Posted on by Kayla Korzekwinski

Bioanalysis • May 2015

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Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee.

Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dried urine spots (DUS), and perform a comparability analysis with liquid matrices.