695 results on '"Strauss, David G."'
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2. Naloxone for Opioid Overdose: Reply
3. A Bioanalytical Method for Quantification of N-nitrosodimethylamine (NDMA) in Human Plasma and Urine with Different Meals and following Administration of Ranitidine
4. General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
5. Determination of five positive control drugs in hERG external solution (buffer) by LC-MS/MS to support in vitro hERG assay as recommended by ICH S7B
6. Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen clinical trial
7. A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model
8. A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm
9. Developing an animal model to detect drug–drug interactions impacting drug-induced respiratory depression
10. Correction of the QRS duration for heart rate
11. Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose
12. The 43rd International Society for Computerized Electrocardiology ECG initiative for the automated detection of strict left bundle branch block
13. Ejection fraction in left bundle branch block is disproportionately reduced in relation to amount of myocardial scar
14. International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment
15. Trends and Outcomes of Catheter Ablation for Ventricular Tachycardia in a Community Cohort
16. CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion
17. The ability of the electrocardiogram in left bundle branch block to detect myocardial scar determined by cardiovascular magnetic resonance
18. Comparative analysis of media effects on human induced pluripotent stem cell-derived cardiomyocytes in proarrhythmia risk assessment
19. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting
20. A novel ECG detector performance metric and its relationship with missing and false heart rate limit alarms
21. ICH S7B in vitro assays do not address mechanisms of QTC prolongation for peptides and proteins – data in support of not needing dedicated QTC studies
22. Electrocardiographic biomarkers to confirm drug's electrophysiological effects used for proarrhythmic risk prediction under CiPA
23. Predicting potential adverse events using safety data from marketed drugs
24. Clinical Trials in a Dish
25. Dr. Galen Wagner (1939-2016) as an Academic Writer: An Overview of his Peer-reviewed Scientific Publications
26. Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
27. Opioid Overdose: Limitations in Naloxone Reversal of Respiratory Depression and Prevention of Cardiac Arrest
28. Reproducibility of drug-induced effects on the contractility of an engineered heart tissue derived from human pluripotent stem cells
29. Evolving regulatory paradigm for proarrhythmic risk assessment for new drugs
30. Computing the spatial QRS-T angle using reduced electrocardiographic lead sets
31. The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress
32. An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel
33. Scar burden assessed by Selvester QRS score predicts prognosis, not CRT clinical benefit in preventing heart failure event and death: A MADIT-CRT sub-study
34. A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm
35. Heart Rate Correction of the J-to-Tpeak Interval
36. ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QTC Studies.
37. In memoriam: A tribute to the work and lives of Ron Selvester and Rory Childers
38. Sex differences in drug-induced changes in ventricular repolarization
39. Computer simulations to investigate the causes of T-wave notching
40. The derivation of the spatial QRS-T angle and the spatial ventricular gradient using the Mason–Likar 12-lead electrocardiogram
41. Selvester scoring in patients with strict LBBB using the QUARESS software
42. Immediate mechanical effects of acute left bundle branch block by speckle tracked strain
43. Investigation of potential mechanisms of sex differences in quinidine-induced torsade de pointes risk
44. Prevalence of manual Strauss LBBB criteria in patients diagnosed with the automated Glasgow LBBB criteria
45. Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators in Medicare Patients
46. Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the Food and Drug Administration
47. Incidence of strict versus nonstrict left bundle branch block after transcatheter aortic valve replacement
48. Associations of electrocardiographic P-wave characteristics with left atrial function, and diffuse left ventricular fibrosis defined by cardiac magnetic resonance: The PRIMERI Study
49. New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science
50. Advancing Innovations in Biosimilars
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