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Clinical and Translational Science

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https://www.readbyqxmd.com/read/29436156/cytochrome-p450-genetic-variation-associated-with-tamoxifen-biotransformation-in-american-indian-and-alaska-native-people
#1
Burhan A Khan, Renee Robinson, Alison E Fohner, LeeAnna I Muzquiz, Brian D Schilling, Julie A Beans, Matthew J Olnes, Laura Trawicki, Holly Frydenlund, Cindi Laukes, Patrick Beatty, Brian Phillips, Deborah Nickerson, Kevin Howlett, Denise A Dillard, Timothy A Thornton, Kenneth E Thummel, Erica L Woodahl
Despite evidence that pharmacogenetics can improve tamoxifen pharmacotherapy, there are few studies with American Indian and Alaska Native (AIAN) people. We examined variation in cytochrome P450 (CYP) genes (CYP2D6, CYP3A4, CYP3A5, and CYP2C9) and tamoxifen biotransformation in AIAN patients with breast cancer (n = 42) from the Southcentral Foundation in Alaska and the Confederated Salish and Kootenai Tribes in Montana. We tested for associations between CYP diplotypes and plasma concentrations of tamoxifen and metabolites...
February 13, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29423973/it-s-time-to-reverse-our-thinking-the-reverse-translation-research-paradigm
#2
EDITORIAL
Valentina Shakhnovich
No abstract text is available yet for this article.
February 9, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29392871/challenges-and-opportunities-in-dose-finding-in-oncology-and-immuno-oncology
#3
REVIEW
Yan Ji, Jin Y Jin, David M Hyman, Geoffrey Kim, Ajit Suri
No abstract text is available yet for this article.
February 1, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29383836/physician-awareness-of-immune-responses-to-polyethylene-glycol-drug-conjugates
#4
Morgan D McSweeney, Zina C Versfeld, Delesha M Carpenter, Samuel K Lai
Antibodies against polyethylene glycol (PEG) can critically jeopardize the efficacy and safety of PEGylated therapeutics. For some PEG-drugs, a sizeable fraction of patients develop anti-PEG antibodies (APA), leading to reduced efficacy and potential adverse events. We surveyed physicians from several specialties to assess their awareness of APA. Overall, 83% of the physicians surveyed indicated that they have recently prescribed PEGylated drugs. Although 91% of respondents were aware of antidrug antibodies in general, only 22% were aware of APA responses...
January 31, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29351372/a-preclinical-population-pharmacokinetic-model-for-anti-cd20-cd3-t-cell-dependent-bispecific-antibodies
#5
Gregory Z Ferl, Arthur Reyes, Liping L Sun, Melissa Cheu, Amy Oldendorp, Saroja Ramanujan, Eric G Stefanich
CD20 is a cell-surface receptor expressed by healthy and neoplastic B cells and is a well-established target for biologics used to treat B-cell malignancies. Pharmacokinetic (PK) and pharmacodynamic (PD) data for the anti-CD20/CD3 T-cell-dependent bispecific antibody BTCT4465A were collected in transgenic mouse and nonhuman primate (NHP) studies. Pronounced nonlinearity in drug elimination was observed in the murine studies, and time-varying, nonlinear PK was observed in NHPs, where three empirical drug elimination terms were identified using a mixed-effects modeling approach: i) a constant nonsaturable linear clearance term (7 mL/day/kg); ii) a rapidly decaying time-varying, linear clearance term (t½  = 1...
January 19, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29351371/implementation-of-standardized-clinical-processes-for-tpmt-testing-in-a-diverse-multidisciplinary-population-challenges-and-lessons-learned
#6
Kristin W Weitzel, D Max Smith, Amanda R Elsey, Benjamin Q Duong, Benjamin Burkley, Michael Clare-Salzler, Yan Gong, Tara A Higgins, Benjamin Kong, Taimour Langaee, Caitrin W McDonough, Benjamin J Staley, Teresa T Vo, Dyson T Wake, Larisa H Cavallari, Julie A Johnson
Although thiopurine S-methyltransferase (TPMT) genotyping to guide thiopurine dosing is common in the pediatric cancer population, limited data exist on TPMT testing implementation in diverse, multidisciplinary settings. We established TPMT testing (genotype and enzyme) with clinical decision support, provider/patient education, and pharmacist consultations in a tertiary medical center and collected data over 3 years. During this time, 834 patients underwent 873 TPMT tests (147 (17%) genotype, 726 (83%) enzyme)...
January 19, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29316365/developing-pharmacogenomic-reports-insights-from-patients-and-clinicians
#7
Laney K Jones, Alanna Kulchak Rahm, Michael R Gionfriddo, Janet L Williams, Audrey L Fan, Rebecca A Pulk, Eric A Wright, Marc S Williams
Increasingly, for a variety of indications, patients have their genomes sequenced and actionable results returned. A subset of returned results is pharmacogenomic (PGx) variants involved in the metabolism or action of medications. Although the impact of these variants on health is well-documented, little research exists on how to communicate these findings to patients and clinicians. We conducted semistructured interviews with end users to understand how best to communicate PGx results. Overall, patients and clinicians had similar opinions regarding report content, delivery, and application...
January 8, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29272564/mechanisms-of-action-and-clinical-development-of-elotuzumab
#8
REVIEW
David Ritchie, Marco Colonna
No abstract text is available yet for this article.
December 22, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29271559/application-of-a-dynamic-map-for-learning-communicating-navigating-and-improving-therapeutic-development
#9
John A Wagner, Andrew M Dahlem, Lynn D Hudson, Sharon F Terry, Russ B Altman, C Taylor Gilliland, Christopher DeFeo, Christopher P Austin
Drug discovery and development is commonly schematized as a "pipeline," and, although appreciated by drug developers to be a useful oversimplification, this cartology may perpetuate inaccurate notions of straightforwardness and is of minimal utility for process engineering to improve efficiency. To create a more granular schema, a group of drug developers, researchers, patient advocates, and regulators developed a crowdsourced atlas of the steps involved in translating basic discoveries into health interventions, annotated with the steps that are particularly prone to difficulty or failure...
December 22, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29266809/reverse-translation-of-us-food-and-drug-administration-reviews-of-oncology-new-molecular-entities-approved-in-2011-2017-lessons-learned-for-anticancer-drug-development
#10
REVIEW
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
No abstract text is available yet for this article.
December 19, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29232772/s-nitrosohemoglobin-levels-and-patient-outcome-after-transfusion-during-pediatric-bypass-surgery
#11
Faisal Matto, Peter C Kouretas, Richard Smith, Jacob Ostrowsky, Anthony J Cina, Douglas T Hess, Jonathan S Stamler, James D Reynolds
Banked blood exhibits impairments in nitric oxide (NO)-based oxygen delivery capability, reflected in rapid depletion of S-nitrosohemoglobin (SNO-Hb). We hypothesized that transfusion of even freshly-stored blood used in pediatric heart surgery would reduce SNO-Hb levels and worsen outcome. In a retrospective review (n = 29), the percent of estimated blood volume (% eBV) replaced by transfusion directly correlated with ventilator time and inversely correlated with kidney function; similar results were obtained in a prospective arm (n = 20)...
December 12, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29205871/pharmacogenetic-analysis-of-the-model-based-pharmacokinetics-of-five-anti-hiv-drugs-how-does-this-influence-the-effect-of-aging
#12
Jingxian Chen, Farida S Akhtari, Michael J Wagner, Oscar Suzuki, Tim Wiltshire, Alison A Motsinger-Reif, Julie B Dumond
Analysis of aging and pharmacogenetics (PGx) on antiretroviral pharmacokinetics (PKs) could inform precision dosing for older human HIV-infected patients. Seventy-four participants receiving either atazanavir/ritonavir (ATV/RTV) or efavirenz (EFV) with tenofovir/emtricitabine (TFV/FTC) provided PK and PGx information. Aging-PGx-PK association and interaction analyses were conducted using one-way analysis of variance (ANOVA), multiple linear regression, and Random Forest ensemble methods. Our analyses associated unbound ATV disposition with multidrug resistance protein (MRP)4, RTV with P-glycoprotein (P-gp), and EFV with cytochrome P450 (CYP)2B6 and MRP4 genetic variants...
December 3, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29194983/translational-development-of-microbiome-based-therapeutics-kinetics-of-e-coli-nissle-and-engineered-strains-in-humans-and-nonhuman-primates
#13
Caroline Kurtz, William S Denney, Larry Blankstein, Sarah E Guilmain, Suman Machinani, Jonathan Kotula, Saurabh Saha, Paul Miller, Aoife M Brennan
Understanding the pharmacology of microbiome-based therapeutics is required to support the development of new medicines. Strains of E. coli Nissle (EcN) were genetically modified and administered to cynomolgus monkeys at doses of 1 × 109 and 1 × 1012 colony-forming units (CFU)/day for 28 days. A clinical study to evaluate the exposure and clearance of EcN in healthy volunteers was also performed. Healthy subjects received oral doses of EcN, 2.5 to 25 × 109 CFU 3 times daily for 28 days or a single day. In cynomolgus monkeys, replicating strains yielded higher fecal concentrations than nonreplicating strains and persisted for longer following cessation of dosing...
December 1, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29194962/diagnostic-testing-for-zika-observing-rapid-translation-during-a-public-health-emergency
#14
Shaheen Kurani, Elitza Theel, Alexandra Greenberg-Worisek
No abstract text is available yet for this article.
December 1, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29193769/inflammatory-and-physiological-consequences-of-debridement-of-fibrous-tissue-after-volumetric-muscle-loss-injury
#15
Benjamin T Corona, Jessica C Rivera, Sarah M Greising
Volumetric muscle loss (VML) injuries present chronic loss of muscle fibers followed by expansive fibrotic tissue deposition. Regenerative medicine therapies are under development to promote regeneration. However, mitigation of the expansive fibrous tissue is required for integration with the remaining muscle. Using a porcine VML model, delayed debridement of injury fibrosis was performed 3 months post-VML and observed for an additional 4 weeks. A second group underwent the initial VML and was observed for 4 weeks, allowing comparison of initial fibrosis formation and debrided groups...
November 28, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29193749/clinical-implementation-of-pharmacogenetic-testing-in-a-hospital-of-the-spanish-national-health-system-strategy-and-experience-over-3-years
#16
Alberto M Borobia, Irene Dapia, Hoi Y Tong, Pedro Arias, Mario Muñoz, Jair Tenorio, Rafael Hernández, Irene García García, Gema Gordo, Elena Ramírez, Jesús Frías, Pablo Lapunzina, Antonio J Carcas
In 2014, we established a pharmacogenetics unit with the intention of facilitating the integration of pharmacogenetic testing into clinical practice. This unit was centered around two main ideas: i) individualization of clinical recommendations, and ii) preemptive genotyping in risk populations. Our unit is based on the design and validation of a single nucleotide polymorphism (SNP) microarray, which has allowed testing of 180 SNPs associated with drug response (PharmArray), and clinical consultation regarding the results...
November 28, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29193724/reverse-translation-in-advancing-pharmacotherapy-in-pediatric-rheumatology-a-logical-approach-in-rare-diseases-with-limited-resources
#17
Mara L Becker, Ryan S Funk
No abstract text is available yet for this article.
November 28, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29168990/model-based-meta-analysis-for-multiple-myeloma-a-quantitative-drug-independent-framework-for-efficient-decisions-in-oncology-drug-development
#18
Zhaoyang Teng, Neeraj Gupta, Zhaowei Hua, Guohui Liu, Vivek Samnotra, Karthik Venkatakrishnan, Richard Labotka
The failure rate for phase III trials in oncology is high; quantitative predictive approaches are needed. We developed a model-based meta-analysis (MBMA) framework to predict progression-free survival (PFS) from overall response rates (ORR) in relapsed/refractory multiple myeloma (RRMM), using data from seven phase III trials. A Bayesian analysis was used to predict the probability of technical success (PTS) for achieving desired phase III PFS targets based on phase II ORR data. The model demonstrated a strongly correlated (R(2) = 0...
November 23, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29314733/erratum-to-phase-i-studies-of-acebilustat-pharmacokinetics-pharmacodynamics-food-effect-and-cyp3a-induction
#19
(no author information available yet)
No abstract text is available yet for this article.
January 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29150914/navigating-the-clinical-translation-of-medical-devices-the-case-of-radiofrequency-ablation
#20
Abdel Armaiz Flores, Marianna L Oppenheimer Velez, Scott M Thompson, Anthony J Windebank, Alexandra J Greenberg-Worisek
No abstract text is available yet for this article.
November 18, 2017: Clinical and Translational Science
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