Celerion (Canada)

Recent papers from Celerion (Canada)

1. 18 th GCC Closed Forum: Compliance with FDA Biomarkers Guidance, Novel ELN/LIMS Platforms, Sample Reconciliation, Emerging Technologies, Improvements in ELISpot, Post-extraction Sample Stability, LBA Singlicate, Regulatory Inspections, Chicken anti-Human IgG, Cross-validation HarmonizationBioanalysis · 2026
2. Randomized trial of pharmacokinetic and pharmacodynamic effects of 13.2 mg intranasal epinephrine treatment in congestionAnnals of Allergy Asthma & Immunology · 2024
3. Innovative Approaches to Optimize Clinical Transporter Drug–Drug Interaction StudiesPharmaceutics · 2024
4. Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy ParticipantsClinical Pharmacology in Drug Development · 2024
5. Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT LiabilityClinical Pharmacology & Therapeutics · 2024
6. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approachesJournal of Extracellular Vesicles · 2024
7. Rifampin Drug–Drug–Interaction Studies: Reflections on the Nitrosamine Impurities IssueClinical Pharmacology & Therapeutics · 2022
8. Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin: A Randomized, Dose Escalation Study in Healthy AdultsToxins · 2020
9. Evaluating cardiac risk: exposure response analysis in early clinical drug developmentDrug Healthcare and Patient Safety · 2018
10. Evaluation of the Potential for Drug Interactions With Patiromer in Healthy VolunteersJournal of Cardiovascular Pharmacology and Therapeutics · 2017
11. Update and trends on pharmacokinetic studies in patients with impaired renal function: practical insight into application of the FDA and EMA guidelinesExpert Review of Clinical Pharmacology · 2016
12. A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN‐02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy AdultsHeadache The Journal of Head and Face Pain · 2016
13. Pharmacokinetics of cabozantinib tablet and capsule formulations in healthy adultsAnti-Cancer Drugs · 2016
14. Effect of Renal and Hepatic Impairment on the Pharmacokinetics of CabozantinibThe Journal of Clinical Pharmacology · 2016
15. Evaluation of the effect of food and gastric pH on the single‐dose pharmacokinetics of cabozantinib in healthy adult subjectsThe Journal of Clinical Pharmacology · 2015
16. Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic ImpairmentAntimicrobial Agents and Chemotherapy · 2015
17. Pharmacokinetic (PK) drug interaction studies of cabozantinib: Effect of CYP3A inducer rifampin and inhibitor ketoconazole on cabozantinib plasma PK and effect of cabozantinib on CYP2C8 probe substrate rosiglitazone plasma PKThe Journal of Clinical Pharmacology · 2015
18. Steady-state bioavailability of prescription omega-3 on a low-fat diet is significantly improved with a free fatty acid formulation compared with an ethyl ester formulation: the ECLIPSE II studyVascular Health and Risk Management · 2013
19. Improved Pharmacokinetics of Sumatriptan With B reath P owered™ Nasal Delivery of Sumatriptan PowderHeadache The Journal of Head and Face Pain · 2013
20. Impact of Intravenous Naltrexone on Intravenous Morphine-Induced High, Drug Liking, and Euphoric Effects in Experienced, Nondependent Male Opioid UsersDrugs in R&D · 2011