45 results on '"Engwall, Michael"'
Search Results
2. Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As
3. The in vivo QTc core assay: An evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies
4. Safety Pharmacology Evaluation of Biopharmaceuticals
5. Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture
6. Clinical Implications and Translation of an Off-Target Pharmacology Profiling Hit: Adenosine Uptake Inhibition In Vitro
7. The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs
8. An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs
9. Safety Pharmacology Evaluation of Biopharmaceuticals
10. The evaluation of drug-induced changes in cardiac inotropy in dogs: Results from a HESI-sponsored consortium
11. Evaluation of levocetirizine in beagle dog and cynomolgus monkey telemetry assays: Defining the no QTc effect profile by timepoint and concentration‐QTc analysis
12. Evaluation of levocetirizine in beagle dog and cynomolgus monkey telemetry assays: Defining the no QTc effect profile by timepoint and concentration‐QTc analysis.
13. Corrigendum to “The in vivo QTc core assay: An evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies” [Journal of Pharmacological and Toxicological Methods 109 (2021) 107067].
14. Safety Pharmacology Evaluation of Biopharmaceuticals
15. Inhibition of casein kinase I ε/δ produces phase shifts in the circadian rhythms of Cynomolgus monkeys
16. Evaluation of moxifloxacin in canine and non‐human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration‐QTc analysis
17. ILSI–HESI cardiovascular safety subcommittee dataset: An analysis of the statistical properties of QT interval and rate-corrected QT interval (QTc)
18. The Effects of Repeat-Dose Doxorubicin on Cardiovascular Functional Endpoints and Biomarkers in the Telemetry-Equipped Cynomolgus Monkey
19. Leveraging machine learning for automated ECG and hemodynamic analyses in the anesthetized canine model
20. Baseline characterization of three canine cardiovascular models
21. Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective
22. QT prolongation and proarrhythmia by moxifloxacin: concordance of preclinical models in relation to clinical outcome
23. Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes
24. Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms
25. Considerations for an in vitro, cell-based testing platform for detection of drug-induced inotropic effects in early drug development. Part 2. Designing and fabricating microsystems for assaying cardiac contractility with physiological relevance using human iPSC-cardiomyocytes
26. Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
27. NOAELs or not in safety pharmacology—An industry survey
28. An Assessment of Drug-Induced Changes in Cardiac Inotropy and Lusitropy Parameters in Dogs: Results from a HESI-sponsored Consortium
29. Evaluation of Ivabradine in Isolated Rabbit Heart and Dog Telemetry: Correlation with Clinical Findings
30. An Overview of the Safety Pharmacology Society (SPS) Strategic Plan (2016-2018)
31. Chronic Cardiovascular Evaluation in Obese and Normal Mice
32. An evaluation of the utility of LVdP/dt 40 , QA interval, LVdP/dt min and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs
33. Echocardiography in a toxicology setting
34. Health and environmental sciences institute integrated strategies working group: Update on the evaluation of drug-induced changes in the cardiac inotropy in dogs
35. Cardiovascular assessment of a biotherapeutic in a multiple dose safety pharmacology study
36. Evaluation of a heart rate correction for rat contractility measurements
37. Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals
38. Cardio-pulmonary effects of inhaled solvents: computer assisted measurement and analysis
39. Cardio-pulmonary effects of inhaled solvents: computer assisted measurement and analysis
40. Translation between in vitro inhibition of the cardiac Nav1.5 channel and pre-clinical and clinical QRS widening
41. Ventilatory effects of prolonged systemic (CNS) hypoxia in awake goats
42. QT prolongation and proarrhythmia by moxifloxacin: concordance of preclinical models in relation to clinical outcome.
43. The effects of carotid body hypocapnia on ventilation in goats
44. Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals
45. Ventilatory effects and interactions with change in Pao2 in awake goats.
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