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Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/28224612/clopidogrel-paclitaxel-drug-drug-interaction-a-pharmacoepidemiologic-study
#1
K Agergaard, M Mau-Sørensen, T B Stage, T L Jørgensen, R E Hassel, K D Steffensen, J W Pedersen, M L H Milo, S H Poulsen, A Pottegård, J Hallas, K Brøsen, T K Bergmann
Paclitaxel is mainly eliminated by CYP2C8 in the liver. CYP2C8 is strongly inhibited by the clopidogrel metabolite acyl-β-D-glucuronide. To determine if this interaction has clinical relevance, we identified 48 patients treated with clopidogrel and paclitaxel using databases and a prescription register. Peripheral sensory neuropathy was retrospectively evaluated from medical charts and compared to that of 88 age and sex matched controls treated with paclitaxel and low dose aspirin. By a cumulative dose of 1500 mg paclitaxel, 35% of the patients had developed severe neuropathy...
February 22, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28224611/response-to-ppar%C3%AE-modulation-by-gw501516-an-unsuccessful-exercise-mimetic
#2
LETTER
Shunchang Li, Ismail Laher
No abstract text is available yet for this article.
February 22, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28214288/an-accelerator-mass-spectrometry-enabled-microtracer-study-to-evaluate-the-first-pass-effect-on-the-absorption-of-yh4808
#3
Anhye Kim, Byung-Yong Yu, Stephen R Dueker, Kwang-Hee Shin, Hwa Suk Kim, Hyungmi Ahn, Joo-Youn Cho, Kyung-Sang Yu, In-Jin Jang, Howard Lee
(14) C-labeled YH4808, a novel potassium-competitive acid blocker, was intravenously administered as a microtracer at 80 μg (11.8 kBq or 320 nCi) concomitantly with the non-radiolabeled oral drug at 200 mg to determine the absolute bioavailability and to assess the effect of pharmacogenomics on the oral absorption of YH4808. The absolute bioavailability was low and highly variable (mean, 10.1%; range, 2.3-19.3%), and M3 and M8, active metabolites of YH4808, were formed 22.6- and 38.5-fold higher after oral administration than intravenous administration, respectively...
February 18, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28198005/clinical-pharmacogenetics-implementation-consortium-cpic-guideline-for-pharmacogenetics-guided-warfarin-dosing-2017-update
#4
Julie A Johnson, Kelly E Caudle, Li Gong, Michelle Whirl-Carrillo, C Michael Stein, Stuart A Scott, Ming Ta Michael Lee, Brian F Gage, Stephen E Kimmel, Minoli A Perera, Jeffrey L Anderson, Munir Pirmohamed, Teri E Klein, Nita A Limdi, Larisa H Cavallari, Mia Wadelius
This document is an update to the 2011 Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2C9 and VKORC1 genotypes and warfarin dosing. Evidence from the published literature is presented for CYP2C9, VKORC1, CYP4F2, and rs12777823 genotype-guided warfarin dosing to achieve a target international normalized ratio of 2-3 when clinical genotype results are available. In addition, this updated guideline incorporates recommendations for adult and pediatric patients that are specific to continental ancestry...
February 15, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187521/the-role-of-fcrn-in-the-pharmacokinetics-of-biologics-in-patients-with-multiple-myeloma
#5
LETTER
Joannes F M Jacobs, Diane R Mould
No abstract text is available yet for this article.
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187516/collaborating-to-compete-blood-profiling-atlas-in-cancer-bloodpac-consortium
#6
R L Grossman, B Abel, S Angiuoli, J C Barrett, D Bassett, K Bramlett, G M Blumenthal, A Carlsson, R Cortese, J DiGiovanna, B Davis-Dusenbery, R Dittamore, D A Eberhard, P Febbo, M Fitzsimons, Z Flamig, J Godsey, J Goswami, A Gruen, F O Guzman, J Han, D Hayes, J Hicks, D Holloway, D Hovelson, J Johnson, H Juhl, R Kalamegham, R Kamal, Q Kang, G J Kelloff, M Klozenbuecher, A Kolatkar, P Kuhn, K Langone, R Leary, P Loverso, H Manmathan, A-M Martin, J Martini, D Miller, M Mitchell, T Morgan, R Mulpuri, T Nguyen, G Otto, A Pathak, E Peters, R Philip, E Posadas, D Reese, M G Reese, D Robinson, A D Rossi, H Sakul, J Schageman, S Singh, H I Scher, K Schmitt, A Silvestro, J Simmons, T Simmons, J Sislow, A Talasaz, P Tang, M Tewari, S Tomlins, H Toukhy, H R Tseng, M Tuck, A Tzou, J Vinson, Y Wang, W Wells, A Welsh, J Wilbanks, J Wolf, L Young, J S H Lee, L C Leiman
The cancer community understands the value of blood profiling measurements in assessing and monitoring cancer. We describe an effort amongst academic, government, biotechnology, diagnostic, and pharmaceutical companies called the Blood Profiling Atlas in Cancer (BloodPAC) Project. BloodPAC will aggregate, make freely available, and harmonize for further analyses, raw datasets, relevant associated clinical data (e.g. clinical diagnosis, treatment history and outcomes), and sample preparation and handling protocols to accelerate the development of blood profiling assays...
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187513/collaboration-to-accelerate-proteogenomics-cancer-care-the-department-of-veterans-affairs-department-of-defense-and-the-national-cancer-institute-s-applied-proteogenomics-organizational-and-learning-apollo-network
#7
L D Fiore, H Rodriguez, C D Shriver
The ability to interrogate cancer at the proteogenomic level has the potential to transform oncology care from trial-and-error treatment strategies based on the anatomy and genomic profiling of tumors to one that is precisely based on the tumor's molecular profile. The next step in the evolution of precision oncology is developing proteogenomic approaches that make no exclusive assumptions a priori as to the molecular level of the patient's disease. The DoD, VA, and NCI responded to the Cancer Moonshot initiative by linking each agency's unique capabilities in clinical and basic science, computing, and high-throughput sequencing...
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187506/the-effect-of-gene-variants-on-levonorgestrel-pharmacokinetics-when-combined-with-antiretroviral-therapy-containing-efavirenz-or-nevirapine
#8
M Neary, M Lamorde, A Olagunju, K M Darin, C Merry, P Byakika-Kibwika, D J Back, M Siccardi, A Owen, K K Scarsi
Reduced levonorgestrel concentrations from the levonorgestrel contraceptive implant was previously seen when given concomitantly with efavirenz. We sought to assess whether single nucleotide polymorphisms (SNPs) in genes involved in efavirenz and nevirapine metabolism were linked to these changes in levonorgestrel concentration. SNPs in CYP2B6, CYP2A6, NR1I2 and NR1I3 were analysed. Associations of participant demographics and genotype with levonorgestrel pharmacokinetics were evaluated in HIV-positive women using the levonorgestrel implant plus efavirenz- or nevirapine-based ART, in comparison to ART-naïve women using multivariate linear regression...
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187497/antiretroviral-therapy-with-efavirenz-accentuates-pregnancy-associated-reduction-of-dihydroartemisinin-piperaquine-exposure-during-malaria-chemoprevention
#9
Richard Kajubi, Liusheng Huang, Prasanna Jagannathan, Nona Chamankhah, Moses Were, Theodore Ruel, Catherine A Koss, Abel Kakuru, Norah Mwebaza, Moses Kamya, Diane Havlir, Grant Dorsey, Philip J Rosenthal, Francesca T Aweeka
Dihydroartemisinin (DHA)-piperaquine is promising for malaria chemoprevention in pregnancy. We assessed impacts of pregnancy and efavirenz-based antiretroviral therapy on exposure to DHA and piperaquine in pregnant Ugandan women. Intensive sampling was performed at 28 weeks gestation in 31 HIV-uninfected pregnant women, in 27 HIV-infected pregnant women receiving efavirenz, and in 30 HIV-uninfected non-pregnant women. DHA peak concentration and area under the concentration time curve (AUC0-8hr ) were 50% and 47% lower, respectively, and piperaquine AUC0-21d was 40% lower in pregnant women compared to non-pregnant women...
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28187492/are-evidence-standards-different-for-genomic-vs-clinical-based-precision-medicine-a-quantitative-analysis-of-individualized-warfarin-therapy
#10
Devender S Dhanda, Gregory F Guzauskas, Josh J Carlson, Anirban Basu, David L Veenstra
Evidence requirements for implementation of precision medicine (PM), whether informed by genomic or clinical data, are not well defined. Evidence requirements are driven by uncertainty and its attendant consequences; these aspects can be quantified by a novel technique in health economics, value of information analysis (VOI). We utilized VOI analysis to compare the evidence levels over time for warfarin dosing based on pharmacogenomic- vs. amiodarone-warfarin drug-drug interaction information. The primary outcome was the expected value of perfect information (EVPI), which is an estimate of the upper limit of the societal value of conducting future research...
February 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182291/pharmacogenetics-of-voriconazole-cyp2c19-but-also-cyp3a4-need-to-be-genotyped
#11
LETTER
Elodie Gautier-Veyret, Xavier Fonrose, Françoise Stanke-Labesque
No abstract text is available yet for this article.
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182281/essential-medicines-for-children
#12
Hoppu Kalle
WHO defines Essential medicines as those that satisfy the priority health-care needs of the population (1). The right to Essential medicines has been considered an important component of the right to health. In the name of equity children should also have access to appropriate, available, affordable, and quality essential medicines they need, but children's essential medicines are too often missing. This article is protected by copyright. All rights reserved.
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182275/charting-a-course-for-precision-oncology
#13
Dimitri Kusnezov, Jason Paragas
Fields of science have undergone dramatic reorganizations as they have come to terms with the realities of the growing complexities of their problem set, the costs, and the breadth of skills needed to make major progress. Precision medicine, Cancer Moonshot, and changes in computing technology are providing an opportunity for this field to redefine its course. This article is protected by copyright. All rights reserved.
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182274/-cancer-moonshot-connecting-international-liquid-biopsy-efforts-through-academic-partnership
#14
C Dive, S N Shishido, P Kuhn
The Kuhn laboratory at the University of Southern California and the Dive laboratory at the Cancer Research UK's Manchester Institute are teaming up to apply new cancer cell detection technology to identify patients that will progress after initial treatment. Researchers will take a simple blood sample to identify early those patients whose cancer has returned, while analyzing CTCs in great detail, providing new clues on the most effective therapy for the patient's cancer. This article is protected by copyright...
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182273/association-of-time-varying-clearance-of-nivolumab-with-disease-dynamics-and-its-implications-on-exposure-response-analysis
#15
Chao Liu, Jingyu Yu, Hongshan Li, Jiang Liu, Yuan Xu, Pengfei Song, Qi Liu, Hong Zhao, James Xu, Virginia E Maher, Brian P Booth, Geoffrey Kim, Atiqur Rahman, Yaning Wang
Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 programmed death-1 (PD-1) and its ligands, PD-L1 and PD-L2. Nivolumab demonstrated efficacy in clinical trials for various types of cancer. A time-varying clearance was identified for nivolumab. We show that the change of clearance over time is associated with the post-treatment effects: clearance decreases when disease status improves. This interaction between post-treatment effects and drug exposure may lead to a biased steep estimate of exposure-response (E-R) relationship for efficacy...
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182272/data-sharing-clinical-trials-and-biomarkers-in-precision-oncology-challenges-opportunities-and-programs-at-the-department-of-veterans-affairs
#16
L D Fiore, M T Brophy, R E Ferguson, C Shannon, S Turek, K Pierce-Murray, S Ajjarapu, G Huang, C S E Lee, P W Lavori
Cancer genomic research reveals that a similar cancer clinical phenotype (e.g. non-small cell lung cancer) can arise from various mutations in tumor DNA. Thus, organ of origin is not a definitive classification. Further, targeted therapy for cancer patients (precision oncology) capitalizes on knowledge of individual patient mutational status to deliver treatment directed against the protein products of these mutations with the goal of reducing toxicity and enhancing efficacy relative to traditional non-targeted chemotherapy...
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182271/optimizing-treatment-for-patients-with-alk-positive-lung-cancer
#17
Ibiayi Dagogo-Jack, Alice T Shaw, Gregory J Riely
In the nine years since the initial discovery of anaplastic lymphoma kinase (ALK) gene rearrangements in non-small cell lung cancer (NSCLC), there has been tremendous progress, culminating in an ever-expanding repertoire of agents that have activity in this disease. This review article provides an overview of currently approved ALK inhibitors, other ALK inhibitors in development, and commonly described mechanisms of resistance to ALK inhibitors. We also discuss emerging controversies in treatment of patients with ALK positive lung cancer, including the choice of first-line ALK inhibitor and the role of tyrosine kinase inhibitors in the treatment of central nervous system metastases...
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182270/use-of-external-controls-in-regulatory-decision-making
#18
Jonathan P Jarow
No abstract text is available yet for this article.
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182269/why-has-model-informed-precision-dosing-not-yet-become-common-clinical-reality-lessons-from-the-past-and-a-roadmap-for-the-future
#19
Adam S Darwich, Kayode Ogungbenro, Alexander A Vinks, J Robert Powell, Jean-Luc Reny, Niloufar Marsousi, Youssef Daali, David Fairman, Jack Cook, Lawrence J Lesko, Jeannine S McCune, Catherijne A J Knibbe, Saskia N de Wildt, J Steve Leeder, Michael Neely, Athena F Zuppa, Paolo Vicini, Leon Aarons, Trevor N Johnson, James Boiani, Amin Rostami-Hodjegan
Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is however relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare...
February 9, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28182259/artificial-intelligence-ai-systems-for-interpreting-complex-medical-data-sets
#20
Russ B Altman
Advances in machine intelligence have created powerful capabilities in algorithms that find hidden patterns in data, classify objects based on their measured characteristics, and associate similar patients/diseases/drugs based on common features. However, artificial intelligence applications in medical data have several technical challenges: complex and heterogeneous data sets, noisy medical data sets, and explaining their output to users. There are also social challenges related to intellectual property, data provenance, regulatory issues, economics and liability...
February 9, 2017: Clinical Pharmacology and Therapeutics
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