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| 2. |
- Bonate, Peter L., et al.
(författare)
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Training the next generation of pharmacometric modelers : a multisector perspective
- 2023
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Ingår i: Journal of Pharmacokinetics and Pharmacodynamics. - : Springer Nature. - 1567-567X .- 1573-8744. ; 51:1, s. 5-31
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Tidskriftsartikel (refereegranskat)abstract
- The current demand for pharmacometricians outmatches the supply provided by academic institutions and considerable investments are made to develop the competencies of these scientists on-the-job. Even with the observed increase in academic programs related to pharmacometrics, this need is unlikely to change in the foreseeable future, as the demand and scope of pharmacometrics applications keep expanding. Further, the field of pharmacometrics is changing. The field largely started when Lewis Sheiner and Stuart Beal published their seminal papers on population pharmacokinetics in the late 1970’s and early 1980’s and has continued to grow in impact and use since its inception. Physiological-based pharmacokinetics and systems pharmacology have grown rapidly in scope and impact in the last decade and machine learning is just on the horizon. While all these methodologies are categorized as pharmacometrics, no one person can be an expert in everything. So how do you train future pharmacometricians? Leading experts in academia, industry, contract research organizations, clinical medicine, and regulatory gave their opinions on how to best train future pharmacometricians. Their opinions were collected and synthesized to create some general recommendations.
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| 3. |
- Feeney, Patrick, et al.
(författare)
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Consensus statement : Eriksholm workshop on wideband absorbance measures of the middle ear
- 2013
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Ingår i: Ear and Hearing. - : Lippincott Williams & Wilkins. - 0196-0202 .- 1538-4667. ; 34:Supplement 1, s. 78s-79s
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Tidskriftsartikel (refereegranskat)abstract
- The participants in the Eriksholm Workshop on Wideband Absorbance Measures of the Middle Ear developed statements for this consensus article on the final morning of the Workshop. The presentations of the first 2 days of the Workshop motivated the discussion on that day. The article is divided into three general areas: terminology; research needs; and clinical application.The varied terminology in the area was seen as potentially confusing, and there was consensus on adopting an organizational structure that grouped the family of measures into the term wideband acoustic immittance (WAI), and dropped the term transmittance in favor of absorbance. There is clearly still a need to conduct research on WAI measurements. Several areas of research were emphasized, including the establishment of a greater WAI normative database, especially developmental norms, and more data on a variety of disorders; increased research on the temporal aspects of WAI; and methods to ensure the validity of test data. The area of clinical application will require training of clinicians in WAI technology. The clinical implementation of WAI would be facilitated by developing feature detectors for various pathologies that, for example, might combine data across ear-canal pressures or probe frequencies.
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| 4. |
- Neely, Stephen, et al.
(författare)
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Alternative ear-canal measures related to absorbance
- 2013
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Ingår i: Ear and Hearing. - : Lippincott Williams & Wilkins. - 0196-0202 .- 1538-4667. ; 34:Supplement 1, s. 72s-77s
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Tidskriftsartikel (refereegranskat)abstract
- Several alternative ear-canal measures are similar to absorbance in their requirement for prior determination of a Thévenin-equivalent sound source. Examples are (1) sound intensity level, (2) forward pressure level, (3) time-domain ear-canal reflectance, and (4) cochlear reflectance. These four related measures are similar to absorbance in their utilization of wideband stimuli and their focus on recording ear-canal sound pressure. The related measures differ from absorbance in how the ear-canal pressure is analyzed and in the type of information that is extracted from the recorded response. Sound intensity level and forward pressure level have both been shown to be better as measures of sound level in the ear canal compared with sound pressure level because they reduced calibration errors due to standing waves in studies of behavioral thresholds and otoacoustic emissions. Time-domain ear-canal reflectance may be used to estimate ear-canal geometry and may have the potential to assess middle ear pathology. Cochlear reflectance reveals information about the inner ear that is similar to what is provided by other types of otoacoustic emissions, and may have theoretical advantages that strengthen its interpretation.
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| 5. |
- Shimada, Yuichi J., et al.
(författare)
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Impact of glycoprotein IIb/IIIa inhibitors on the efficacy and safety of ticagrelor compared with clopidogrel in patients with acute coronary syndromes : Analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial
- 2016
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Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 177, s. 1-8
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Tidskriftsartikel (refereegranskat)abstract
- Background Ticagrelor reduced cardiovascular events compared with clopidogrel in PLATO without increasing overall major bleeding. We evaluated whether the use of glycoprotein IIb/IIIa inhibitor (GPI) impacts the relative efficacy and safety of ticagrelor compared with clopidogrel. Methods PLATO randomized 18,624 subjects with acute coronary syndrome to ticagrelor versus clopidogrel. The primary efficacy end point was cardiovascular death/myocardial infarction/stroke, and the primary safety end point was major bleeding. The use of GPI was at the physician's discretion and open-label. We evaluated outcomes at 30 days stratified by GPI use in the subgroup of 9,983 patients who underwent percutaneous coronary intervention (PCI) within 72 hours. Results A total of 4,020 (40%) received a GPI. Those receiving a GPI were more likely to be younger, be male, and undergo multivessel PCI. There was no interaction between treatment and GPI use for the primary efficacy and safety end points. Patients treated without GPI had a lower rate of definite stent thrombosis and higher rate of minor/major bleeding with ticagrelor compared with clopidogrel (P<.05), whereas there was no such difference with GPI (P interaction <.05). Conclusions In patients with acute coronary syndrome undergoing early PCI, the efficacy and safety of ticagrelor as compared with clopidogrel were not modified by GPI use according to the primary efficacy and safety end point of the trial, although there were indications of greater benefit on definite stent thrombosis and more major or minor bleeding with ticagrelor in patients without (vs with) GPI treatment.
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| 7. |
- Sun, Michelle T., et al.
(författare)
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Meta-Analysis of Intraocular Bleeding With Dual Antiplatelet Therapy Using P2Y12 Inhibitors Prasugrel or Ticagrelor
- 2020
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Ingår i: American Journal of Cardiology. - : EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC. - 0002-9149 .- 1879-1913. ; 125:8, s. 1280-1283
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Forskningsöversikt (refereegranskat)abstract
- Intraocular bleeding is a devastating clinical event due to its potentially blinding nature. It is not known if determine if dual antiplatelet therapy using aspirin and potent P2Y12 inhibitors increases this risk. We searched MEDLINE and ClinicalTrials.gov for randomized controlled trials that were phase III, randomly assigned patients to dual antiplatelet therapy with either aspirin and a potent P2Y12 inhibitor or aspirin and clopidogrel, had follow-up of 6 months, and at least 200 patients. Corresponding authors were contacted for intraocular bleeding data. Inverse-variance, weighted, fixed-effects meta-analysis was undertaken, with random-effects meta-analysis performed as a sensitivity analysis. Four trials enrolling 42,850 patients were included. The median follow-up ranged from 12 to 14 months. There was overall low risk of bias. Pooled analysis demonstrated no statistically significant increase in the risk of intraocular bleeding with dual antiplatelet therapy using potent P2Y12 inhibitors compared with clopidogrel (risk ratio 0.89, 95% confidence interval 0.58 to 136). There was no significant heterogeneity observed across trials (I-2 statistic 0%, p = 0.98). The use of random-effects meta-analysis did not change the effect estimate or confidence intervals, and the results appeared similar when stratified by potent P2Y12 inhibitor (p = 0.97). In conclusion, this collaborative meta-analysis of dual antiplatelet trials does not suggest that the risk of intraocular bleeding is increased with the use of potent P2Y12 inhibitors compared with clopidogrel. Our results suggest that these potent P2Y12 inhibitors may continue to be used cautiously where indicated as part of dual antiplatelet therapy, even in those at high risk of spontaneous intraocular bleeding. Crown Copyright (C) 2020 Published by Elsevier Inc. All rights reserved.
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| 8. |
- Voss, Susan, et al.
(författare)
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Factors that introduce intrasubject variability into ear-canal absorbance measurements
- 2013
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Ingår i: Ear and Hearing. - : Lippincott Williams & Wilkins. - 0196-0202 .- 1538-4667. ; 34:Supplement 1, s. 60s-64s
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Tidskriftsartikel (refereegranskat)abstract
- Wideband immittance measures can be useful in analyzing acoustic sound flow through the ear and also have diagnostic potential for the identification of conductive hearing loss as well as causes of conductive hearing loss. To interpret individual measurements, the variability in test–retest data must be described and quantified. Contributors to variability in ear-canal absorbance–based measurements are described in this article. These include assumptions related to methodologies and issues related to the probe fit within the ear and potential acoustic leaks. Evidence suggests that variations in ear-canal cross-sectional area or measurement location are small relative to variability within a population. Data are shown to suggest that the determination of the Thévenin equivalent of the ER-10C probe introduces minimal variability and is independent of the foam ear tip itself. It is suggested that acoustic leaks in the coupling of the ear tip to the ear canal lead to substantial variations and that this issue needs further work in terms of potential criteria to identify an acoustic leak. In addition, test–retest data from the literature are reviewed.
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