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Celerion
Pharmaceutical Manufacturing
Lincoln, NE 14,663 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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In a dedicated TQT study, 12-lead ECG digital recordings are collected following therapeutic and supratherapeutic dose administrations of a study drug. Typically, these are randomized, placebo- and positive-controlled, 4-arm clinical trials. In this tutorial, we describe situations when a standalone TQT study is recommended, which can depend on the study drug’s mechanism of action, its drug class as well as PK and safety profile. Read the CPT tutorial: Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability https://lnkd.in/eeaVxPvT #TQTwaiver #TQTsubstitution #ECGcorelab
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The electrocardiogram’s QT interval occupies a pivotal role in early drug development and has been the focus of clinicians for over 50 years as a biomarker of ventricular repolarization. Now, drug sponsors have options when it comes to proarrhythmic risk assessment of a new chemical entity. In our recent CPT tutorial, we described the regulatory framework for integrated arrhythmia risk prediction models for TQT substitution pathways (ICH E14/S7B Q&A 5.1 and 6.1), delineate potential reasons why a TQT substitution request may be rejected and discuss when a standalone TQT is recommended. #TQTwaiver #TQTsubstitution #ECGcorelab
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The electrocardiogram’s QT interval occupies a pivotal role in early drug development and has been the focus of clinicians for over 50 years as a biomarker of ventricular repolarization. Now, drug sponsors have options when it comes to proarrhythmic risk assessment of a new chemical entity. In our recent CPT tutorial, we described the regulatory framework for integrated arrhythmia risk prediction models for TQT substitution pathways (ICH E14/S7B Q&A 5.1 and 6.1), delineate potential reasons why a TQT substitution request may be rejected and discuss when a standalone TQT is recommended. #TQTwaiver #TQTsubstitution #ECGcorelab
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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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Intranasal spraying of epinephrine is a patient-friendly alternative to the EpiPen autoinjector as a first-line treatment of anaphylaxis. We assessed the exposure to epinephrine after intranasal and intramuscular administration and compared its effect on pulse rate and blood pressure. Check out the poster https://lnkd.in/epfzGhXj #IntranasalDrugAdministration #EpinephrineAlternative
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We’ve conducted over 450 BA/BE studies in the past decade. This significant milestone is attributed to our highly experienced team of scientific and operational experts' ability to run large cohort studies and purpose-built clinics with 650-bed capacity across all sites. Learn more about what makes Celerion stand out as a leading clinical pharmacology CRO: https://lnkd.in/eKtDWH-M #BABEstudies #ClinicalResearch #Bioequivalence #Bioavailability
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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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Join us for a special talk on 5/29 at 11:15 am ET, hosted by AAPS, featuring Dr. Johannes Stanta, Ph.D., from Celerion. Discover groundbreaking developments in gene therapy through Dr. Stanta's presentation on vector shedding assays. Learn about a new sensitive method to detect AAV8 vector shedding in biological samples like blood, plasma, and more. Don't miss out on enhancing your understanding of these pivotal advancements! Enroll now: https://lnkd.in/dvq8iZ79 #GeneTherapy #Biotech #AAPS #HealthcareScience
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Time is running out on WRIB! Don't miss your chance to connect with our team. Swing by booth #33 to explore how we can support your bioanalytical needs and accelerate your drug development program. We're excited to meet you! #WRIB2024 #ClinicalTrialsInnovation #BiomarkerResearch #GeneCellTherapy #SanAntonioEvents