222 results on '"Rouse, Rodney"'
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2. 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
3. Quantitative analysis of underivatized 17 β-estradiol using a high-throughput LC–MS/MS assay – Application to support a pharmacokinetic study in ovariectomized guinea pigs
4. Developing an animal model to detect drug–drug interactions impacting drug-induced respiratory depression
5. Advancing alternative methods to reduce animal testing.
6. Emergence of nosocomial associated opportunistic pathogens in the gut microbiome after antibiotic treatment
7. An alternating polarity switching assay for quantification of oxycodone and topiramate: An application of LC-MS/MS method in support to PK/PD study in rodents
8. Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model
9. A metagenomic analysis for combination therapy of multiple classes of antibiotics on the prevention of the spread of antibiotic-resistant genes
10. MicroRNA biomarkers of pancreatic injury in a canine model
11. The effect of antibiotics on the gut microbiome: a metagenomics analysis of microbial shift and gut antibiotic resistance in antibiotic treated mice
12. Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science
13. Detection of Reg3γ by Immunohistochemistry in Cerulein-Induced Model of Acute Pancreatic Injury in Mice and Rats
14. Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
15. New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science
16. Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia
17. Co-sequencing and novel delayed anti-correlation identify function for pancreatic enriched microRNA biomarkers in a rat model of acute pancreatic injury
18. Calibration and Validation of a Mechanistic COVID‐19 Model for Translational Quantitative Systems Pharmacology – A Proof‐of‐Concept Model Development for Remdesivir
19. 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
20. Regulatory Forum Opinion Piece*: Blinding and Binning in Histopathology Methods in the Biomarker Qualification Process
21. Impact of Pathologists and Evaluation Methods on Performance Assessment of the Kidney Injury Biomarker, Kim-1
22. Discovery of early urinary biomarkers in preclinical study of gentamicin-induced kidney injury and recovery in rats
23. Effect of Oral Ranitidine on Urinary Excretion ofN-Nitrosodimethylamine (NDMA)
24. Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat
25. Assessment Standards: Comparing Histopathology, Digital Image Analysis, and Stereology for Early Detection of Experimental Cisplatin-induced Kidney Injury in Rats
26. High fat diet and GLP-1 drugs induce pancreatic injury in mice☆
27. Autophagy in Pancreatic Acinar Cells in Caerulein-treated Mice: Immunolocalization of Related Proteins and Their Potential as Markers of Pancreatitis
28. In Utero Exposure to Second-Hand Smoke Aggravates the Response to Ovalbumin in Adult Mice
29. Additional file 1 of The effect of antibiotics on the gut microbiome: a metagenomics analysis of microbial shift and gut antibiotic resistance in antibiotic treated mice
30. In utero environmental tobacco smoke exposure alters gene expression in lungs of adult BALB/c mice
31. In utero exposure to environmental tobacco smoke potentiates adult responses to allergen in BALB/c mice
32. Circulating microRNAs as Biomarkers of Drug-Induced Pancreatitis
33. Kidney Injury Biomarkers in Hypertensive, Diabetic, and Nephropathy Rat Models Treated with Contrast Media
34. In Utero Exposure to Second-Hand Smoke Aggravates Adult Responses to Irritants: Adult Second-Hand Smoke
35. Oleic acid and glucose regulate glucagon-like peptide 1 receptor expression in a rat pancreatic ductal cell line
36. Tissue and cellular distribution of gold nanoparticles varies based on aggregation/agglomeration status
37. A high-throughput bioanalytical assay to support pharmacokinetic interaction study of oxycodone and diazepam in Sprague Dawley rats
38. Soot Nanoparticles Promote Biotransformation, Oxidative Stress, and Inflammation in Murine Lungs
39. Combustion-Derived Hydrocarbons Localize to Lipid Droplets in Respiratory Cells
40. Additional file 1: Figure S1. of Co-sequencing and novel delayed anti-correlation identify function for pancreatic enriched microRNA biomarkers in a rat model of acute pancreatic injury
41. Additional file 2: Figure 2. of Co-sequencing and novel delayed anti-correlation identify function for pancreatic enriched microRNA biomarkers in a rat model of acute pancreatic injury
42. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies
43. Evaluation of Immunocompetent Urinary Tract Infected Balb/C Mouse Model For the Study of Antibiotic Resistance Development Using Escherichia Coli CFT073 Infection
44. Additional file 1: Figure S1. of Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions
45. Biomarkers of drug-induced acute kidney injury: a regulatory perspective
46. The Effect of Antibiotics on Gut Microbiome: A Metagenomics Analysis of Microbial Shift and Antibiotic Resistance in Antibiotic Treated Mice
47. Regulatory Science – An Underappreciated Component of Translational Research
48. Determination of Non-Transferrin Bound Iron, Transferrin Bound Iron, Drug Bound Iron and Total Iron in Serum in a Rats after IV Administration of Sodium Ferric Gluconate Complex by Simple Ultrafiltration Inductively Coupled Plasma Mass Spectrometric Detection
49. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization
50. LC-MS/MS based quantitation of ciprofloxacin and its application to antimicrobial resistance study in Balb/c mouse plasma, urine, bladder and kidneys
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