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Celerion
Pharmaceutical Manufacturing
Lincoln, NE 15,093 followers
Celerion Can Take You from First-In-Human through Proof-of-Concept.
About us
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
- Website
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http://www.celerion.com
External link for Celerion
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- Lincoln, NE
- Type
- Privately Held
- Founded
- 2010
- Specialties
- Applied Translational Medicine, Global Clinical Research (Phase I and II, NDA-enabling clinical pharmacology), Data Management and Biometrics, Global Bioanalytical Services (discovery through late phase), Drug Development Services, and Global Clinical Development
Locations
Employees at Celerion
Updates
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Celerion is more than a service provider; we're your trusted partner in bringing next-level breakthroughs to life. Our unique combination of medical expertise, clinical operations experience, and scientific excellence enables you to make timely decisions with expert advice and high-quality data. Learn More: https://lnkd.in/epnrcyEx #LifeChangingScience #AdvancedBioanalysis #DrugDiscovery
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The final guidance highlights the importance of mass balance studies for obtaining quantitative and comprehensive information on drug absorption, distribution, metabolism, and excretion (ADME). Read the guidance: https://lnkd.in/e23QMAfX Learn about Celerion’s approach to ADME studies: https://lnkd.in/e8Hk8bdE #MassBalance #DrugAbsorption #ADME #FDAGuidance
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A DDI study is recommended to evaluate how an investigational drug interacts with other drugs through CYP enzymes and drug transporters by either being a substrate, an inhibitor, or an inducer. Also, a DDI study may be needed if the study drug is intended to be co-administered with other medications, such as combined oral contraceptives (COC) or acid-reducing agents (ARA). Learn about these unique study designs: https://lnkd.in/eUzpEvqm #DDIStudies #DrugInteractions #CYPEnzymes #PharmaResearch
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A pivotal food effect with a high-fat meal, and in some cases a low-fat meal, may be recommended to characterize drug PK during food consumption, especially if the to-be-marketed formulation has changed or efficacy and safety are adversely impacted by a fed/fasting condition. Hungry for more: https://lnkd.in/eKC7EDrx #FoodEffectPK #DrugEfficacySafety #ClinicalPharmacology
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New drugs in development intended for patients with liver disease need to assess how changes in hepatic function can affect drug PK. Hepatic impairment PK studies help inform the drug label with regard to dose adjustment or contraindication for patients with liver disease, like hepatitis. Learn how Celerion partners with specialized clinics across the US and EU for hepatic impairment PK studies: https://lnkd.in/eumysCPi Check out our resource page: https://lnkd.in/eznFHuwS #WorldHepatitisDay #WHD #HepaticImpairment
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Ready to start your renal impairment PK study? Discover how Celerion's expertise can streamline your study design, saving time and budget. Read Now -> https://lnkd.in/ev28i9hc #RenalStudies #ClinicalTrials #PKStudies #Pharmacokinetics
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We offer bespoke study design solutions for early clinical pharmacology studies. Benefit from working with our team of expert PK scientists to leverage their extensive experience in clinical pharmacology study designs. Learn more: https://lnkd.in/eN8XffD #ClinicalPharmacology #PKScientists #ClinicalTrials
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Celerion’s Regulatory Affairs experts have extensive IND authorship, submission, and management experience to relieve you of this vital yet complex and labor-intensive process. Check out our full regulatory & scientific affairs support services: https://lnkd.in/e-sCYGCk #RegulatoryExcellence #PharmaRegulations #RegulatoryAffairs #DrugDevelopment
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Clinical pharmacology studies such as TQT, ADME, hepatic/renal impairment, or drug-drug interaction trials may be recommended for a given biologic drug depending on its moiety size, PK profile, and potential for PD interactions. Check out our article for an overview of each recommended study by biologic drug type. https://lnkd.in/egviY3vA #Biologics #ProductLabeling #DDI #TQT #RenalHepaticPK