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Clinical and Translational Science

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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/29150914/navigating-the-clinical-translation-of-medical-devices-the-case-of-radiofrequency-ablation
#8
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
https://www.readbyqxmd.com/read/29148204/genome-wide-and-phenome-wide-approaches-to-understand-variable-drug-actions-in-electronic-health-records
#9
REVIEW
Jamie R Robinson, Joshua C Denny, Dan M Roden, Sara L Van Driest
No abstract text is available yet for this article.
November 17, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29139198/factors-affecting-drug-development-strategies-in-asian-global-clinical-trials-for-drug-approval-in-japan
#10
Kunihito Asano, Yoshiaki Uyama, Masahiro Tohkin
We assessed the current status of Asian global clinical trials (GCTs) and factors, such as therapeutic areas, main metabolic enzymes targeted, approval status in the United States or the European Union, development strategies, influencing drug-development strategies in Asian GCTs and in general GCTs for drug approval in Japan. The findings suggested that region-specific diseases in Asia, intrinsic and extrinsic ethnic differences between Japanese/Asian and Caucasian populations, and the status of the drugs' development in the United States or the European Union all affected Asian GCTs...
November 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29139191/repurposing-statins-for-renal-protection-is-it-a-class-effect
#11
Stephen J McWilliam, Daniel J Antoine, Munir Pirmohamed
No abstract text is available yet for this article.
November 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29119704/pharmacokinetics-of-rp5063-following-single-doses-to-normal-healthy-volunteers-and-multiple-doses-over-10-days-to-stable-schizophrenic-patients
#12
Marc Cantillon, Robert Ings, Laxminarayan Bhat
RP5063, a multimodal dopamine (D)-serotonin (5-HT) stabilizer, possesses high affinity for D2/3/4 and 5-HT1A/2A/2B/2C/6/7 receptors and moderate affinity for the serotonin transporter. Two phase I studies characterized the pharmacokinetics of a single dose (10 and 15 mg fasting, 15 mg fed/fasting) in healthy volunteers and multiple doses (10, 20, 50, and 100 mg fed) over 10 days in patients with stable schizophrenia. RP5063 displayed a dose-dependent Cmax at 4 to 6 h, linear dose proportionality for both Cmax and AUC, and a half-life between 40 and 71 h...
November 8, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29110398/teaching-targeted-drug-discovery-and-development-to-healthcare-professionals
#13
Renee Fruchter, Meleha Ahmad, Michael Pillinger, Claudia Galeano, Bruce N Cronstein, Gabrielle Gold-von Simson
Drug discovery and development (DDD) is an interdisciplinary enterprise that spans the translational continuum. Despite DDD's importance, formal training within medical and biomedical schools is lacking. In this tutorial, we outline the current educational landscape in DDD and the growing educational need in this area. Lastly, we describe the Health Innovations and Therapeutics concentration as an example of how to design and implement an educational program in DDD. This article is protected by copyright. All rights reserved...
November 7, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29106053/population-pharmacokinetics-of-fosdagrocorat-pf-04171327-a-dissociated-glucocorticoid-receptor-agonist-in-patients-with-rheumatoid-arthritis
#14
Barry Weatherley, Lynn McFadyen, Brinda Tammara
Dissociated agonists of the glucocorticoid receptor (DAGRs) show similar antiinflammatory effects but improved tolerability compared with standard glucocorticoid receptor (GR) agonists. The prodrug fosdagrocorat (PF-04171327), with active DAGR metabolite PF-00251802 (Metabolite-1), is postulated to show superior efficacy over placebo and prednisone in patients with moderate to severe rheumatoid arthritis (RA). We investigated the population pharmacokinetics of active Metabolite-1 and its active metabolite PF-04015475 (Metabolite-2) in patients with moderate to severe RA enrolled in a 12-week, phase II, randomized, double-blind study (NCT01393639)...
November 4, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29084377/using-physiologically-based-pharmacokinetic-modeling-for-mechanistic-insight-cases-of-reverse-translation
#15
Andrea N Edginton
No abstract text is available yet for this article.
October 30, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/29084368/electronic-health-record-phenotypes-for-precision-medicine-perspectives-and-caveats-from-treatment-of-breast-cancer-at-a-single-institution
#16
Matthew K Breitenstein, Hongfang Liu, Kara N Maxwell, Jyotishman Pathak, Rui Zhang
Precision medicine is at the forefront of biomedical research. Cancer registries provide rich perspectives and electronic health record(EHR)s are commonly utilized to gather additional clinical data elements needed for translational research. However, manual annotation is resource-intense and not readily scalable. Informatics-based phenotyping presents an ideal solution, but perspectives obtained can be impacted by both data source and algorithm selection. We derived breast cancer(BC) receptor status phenotypes from structured and unstructured EHR data using rule-based algorithms, including natural language processing(NLP)...
October 30, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28986961/know-your-variability-challenges-in-mechanistic-modeling-of-inflammatory-response-in-inflammatory-bowel-disease-ibd
#17
Katharine V Rogers, Indranil Bhattacharya, Steven W Martin, Satyaprakash Nayak
No abstract text is available yet for this article.
October 6, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28986954/role-of-cyp3a-in-oral-contraceptives-clearance
#18
REVIEW
Nan Zhang, Jihong Shon, Myong-Jin Kim, Chongwoo Yu, Lei Zhang, Shiew-Mei Huang, LaiMing Lee, Doanh Tran, Li Li
No abstract text is available yet for this article.
October 6, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28945957/implementing-the-single-institutional-review-board-model-lessons-from-the-undiagnosed-diseases-network
#19
Kimberly Splinter, Sara Chandros Hull, Ingrid A Holm, Tara L McDonough, Anastasia L Wise, Rachel B Ramoni
No abstract text is available yet for this article.
September 25, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28945944/whole-transcriptome-profiling-an-rna-seq-primer-and-implications-for-pharmacogenomics-research
#20
Ana Caroline C Sá, Wolfgang Sadee, Julie A Johnson
No abstract text is available yet for this article.
September 25, 2017: Clinical and Translational Science
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