A5084038963- Pharmaceutical studies and practices
- Renal Transplantation Outcomes and Treatments
- Pharmacological Effects and Toxicity Studies
- Transplantation: Methods and Outcomes
- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- Antibiotics Pharmacokinetics and Efficacy
- Organ Transplantation Techniques and Outcomes
- Metabolism and Genetic Disorders
- Health Systems, Economic Evaluations, Quality of Life
- Pregnancy and Medication Impact
- Neonatal Health and Biochemistry
- Statistical Methods in Clinical Trials
- Pharmaceutical Economics and Policy
- Pediatric Pain Management Techniques
- HIV/AIDS drug development and treatment
- Polyomavirus and related diseases
- Anesthesia and Sedative Agents
- Renal function and acid-base balance
- Pharmaceutical Practices and Patient Outcomes
- Immune Response and Inflammation
- Hematopoietic Stem Cell Transplantation
- Pharmacology and Obesity Treatment
- Adenosine and Purinergic Signaling
- Electrolyte and hormonal disorders
United States Food and Drug Administration
2016-2025
Center for Drug Evaluation and Research
2016-2025
Translational Sciences (United States)
2025
American College of Clinical Pharmacy
1998-2024
University of Florida
2016-2020
Columbus Oncology and Hematology Associates
2016-2020
University of Pittsburgh
1998-2018
National Institutes of Health
2018
Stanford University
2018
University of Alabama at Birmingham
2018
Study Objectives. To review the labels of United States Food and Drug Administration (FDA)‐approved drugs to identify those that contain pharmacogenomic biomarker information, collect prevalence information on use for which is included in drug labeling. Design. Retrospective analysis. Data Sources. The Physicians' Desk Reference Web site, Drugs@FDA manufacturers' sites were used containing prescription claims database a large pharmacy benefits manager (insuring > 55 million individuals...
Tacrolimus is a substrate for P-glycoprotein (P-gp) and cytochrome (CYP) P4503A. P-gp encoded by the multiple drug resistance gene MDR1 CYP3A major enzyme responsible tacrolimus metabolism. Both CYP3A5 genes have single nucleotide polymorphisms. The objective of this study was to evaluate whether exon21 exon26 polymorphisms polymorphism are associated with disposition in pediatric heart transplant patients. At 3, 6 12 months post transplantation, significant difference blood level per...
Conventional regimens of immunosuppressive drugs often do not prevent chronic rejection after lung transplantation. Topical delivery cyclosporine in addition to conventional systemic immunosuppression might help acute and events.We conducted a single-center, randomized, double-blind, placebo-controlled trial inhaled initiated within six weeks transplantation given immunosuppression. A total 58 patients were randomly assigned inhale either 300 mg aerosol (28 patients) or placebo (30 three...
Physiologically based pharmacokinetic (PBPK) approaches that incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have value in design pediatric trials. Four recent submissions to US Food Drug Administration (FDA) incorporated different PBPK applications drug development. Further testing models for three drugs showed these generally underpredicted clearance. modeling potential improving trials through learn-and-confirm utilized current regulatory...
During pediatric drug development, dedicated pharmacokinetic studies are generally performed in all relevant age groups to support dose selection for subsequent efficacy trials. To our knowledge, no previous assessments regarding the need an intensive study adolescents have been performed.To compare U.S. Food and Drug Administration (FDA)-approved adult adolescent dosing assess utility of allometric scaling prediction clearance population.Adult data were obtained from FDA-approved labels...
Drug dosing in neonates should be based on integrated knowledge concerning the disease to treated, physiological characteristics of neonate, and pharmacokinetics (PK) pharmacodynamics (PD) a given drug. It is critically important that all sources information leveraged optimize dose selection for neonates. Sources may include data from adult studies, pediatric non-clinical (juvenile) animal models, vitro silico models. Depending drug development program, each these modalities could used...
Bronchiolitis obliterans syndrome (BOS) represents a major limitation in lung transplantation. While acuterejection is widely considered the most important risk factor for BOS, impact of HLA-specific antibodies less understood. Of 51 recipients who were prospectively tested during 4.2±1.6-year period, 14 patients developed antibodies. A multi-factorial analysis was performed to correlate prevalence BOS with HLA antibodies, persistent-recurrent acute rejection (ACR-PR),...
Tacrolimus is a potent immunosuppressive agent used in lung transplantation and substrate for both P-glycoprotein (P-gp, encoded by the gene MDR1) cytochrome (CYP) P4503A. A previous study authors identified correlation between tacrolimus blood level per dose with CYP3A5 MDR1 polymorphisms pediatric heart transplant patients. The objective of this was to confirm influence these on dosing adult Adult patients who had been followed at least 1 year after were studied. (ng/mL) (mg/day) 1, 3, 6,...
This study evaluated aerosolized cyclosporine as rescue therapy for lung transplant recipients with unremitting chronic rejection. Nine patients histologic active obliterative bronchiolitis and progressively worsening airway obstruction refractory to conventional immune suppression received cyclosporine. Improvement in rejection histology was seen seven of nine patients. We compared the changes FVC FEV1 over time using linear regression analysis these responders historical control During...
Objectives To measure total serum nitrite and nitrate concentrations in children with the sepsis syndrome as an indicator of endogenous nitric oxide production. determine if there is association between vascular responsiveness to norepinephrine. Design A prospective, clinical study. Setting Tertiary, multidisciplinary, pediatric intensive care unit. Patients Thirty-one syndrome, 18 whom were also hypotensive. Sixteen critically ill without signs served controls. Interventions Blood samples...
Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) a drug. However, adults, especially oldest or those with multiple chronic health conditions, polypharmacy, frailty, are often under-represented in clinical trials new drugs. Deficits current conduct evaluation drugs for adults potential steps to fill knowledge gaps presented this communication. The most important step is increase trial enrollment who...
Background. The maturation of dendritic cells (DC) is influenced by various factors, in particular cytokine-mediated signaling events. These include modulation the activation nuclear factor kappa B (NF-κB), which controls transcription genes encoding major histocompatibility complex (MHC) antigens, and costimulatory/accessory molecules for T-cell activation. Here, we investigated influence cyclosporine A (CsA) on vitro DC, translocation DNA binding NF-κB. Methods. DC progenitors were...
The pharmacokinetics of cyclosporine were evaluated in 41 recipients a cadaveric renal transplant. Cyclosporine was taken by mouth (mean dose 14 mg/kg) on one study day and intravenously infused over 2 hours 4.7 the next day. extracted from whole blood analyzed HPLC. After intravenous infusion, exhibited multicompartmental behavior. mean (± SD) terminal disposition rate constant 0.065 ± 0.036 hours−1 harmonic t½ 10.7 hours. total body clearance 5.73 ml/min/kg apparent volume distribution 4.5...