Advances in Peptide drug formulations have led to the development of target-specific, longer-lasting treatments for patients. The FDA recently issued draft guidance for the clinical pharmacology considerations for peptide drug products. The guidance outlines the importance of assessing immunogenicity and the impact of hepatic impairment and drug-drug interactions on pharmacokinetic (PK) and pharmacodynamics (PD) parameters. Celerion’s team of clinical and bioanalytical experts provides comprehensive solutions for peptide drug development. FDA draft guidance: https://lnkd.in/gYt_weiM Learn about our approach to peptide drug development: https://lnkd.in/emwydYv #Celerion #FDA #DDI #PKStudy
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We have become aware of an individual who is falsely representing themselves as a member of the Celerion HR team. Please be cautious when responding to any communication that purports to come from Celerion. All email communication from Celerion will come from an email address appended @celerion.com. No other addresses are legitimate. #hr
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Partner with us for exceptional clinical trial outcomes through advanced flow cytometry. From customizable panels to precise pharmacodynamic endpoints, our expertise drives your success. Excellence begins with reliable data! Learn more: https://lnkd.in/e95UG7vC #FlowCytometry #ClinicalTrials #Pharmacodynamic
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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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Celerion’s site network is one of the largest for organ insufficiency PK studies. Across the US and EU, we have access to patients and specialist principal investigators with expertise in renal and hepatic impairment PK studies for budget-friendly solutions. Learn more: https://lnkd.in/dMe-77ym #PKStudiesNetwork #RenalHepaticExpertise #GlobalPatientAccess #ClinicalTrialExcellence
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Celerion has been called the most automated bioanalytical laboratory in the industry. Our approach is the strategic incorporation and use of bioanalytical laboratory automation to achieve controlled and error-free assays with improved accuracy, efficiency, and throughput. Our bioanalytical laboratories are market leaders in the implementation of automation with over 25 automation instruments, including Hamilton Stars, Tecan EVOs, and Caliper SciClone G3s. There are many reasons we perform automation in bioanalytical laboratories, including: - Enhanced consistency - Quality improvement - Higher sample throughput - Real-time sample verification - Increased versatility in the workforce - Improve efficient and effective use of labor resources Learn more: https://lnkd.in/eunva39X https://lnkd.in/eTzWgDwz #Bioanalytical #BiotechInnovation #AutomatedLabs #LabEfficiency #ResearchExcellence
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Discover how Celerion’s expertise drives success in renal and hepatic insufficiency studies. Hear from Abbey Townsend, our Senior Director of Global Clinical Development, as she breaks down key challenges and strategies for managing PK studies efficiently and cost-effectively. Watch now to see how our partnerships with top investigators help navigate these complex trials! Contact us to learn how we can support your next drug development program: https://lnkd.in/eznFHuwS #ClinicalResearch #RenalStudies #HepaticStudies #Pharmacokinetics #CRO
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Celerion is heading to the Immunogenicity Summit 2024 from October 15-18! If you're attending and interested in discussing how we can support your immunogenicity needs, we’d love to connect! Event: Immunogenicity Summit 2024 Dates: October 15-18 Schedule a Meeting: Reach out to Renee Louis at renee.louis@celerion.com Let’s collaborate to advance innovation together! Learn more about the event: https://lnkd.in/gSp7v3B #ImmunogenicitySummit #ClinicalTrials #Biotech #LifeSciences #Collaboration #Bioanalytical
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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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In our tutorial: “Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability”, we listed out reasons why a TQT substitution or ‘waiver’ can be denied. Read the tutorial to avoid these common pitfalls. Read the CPT tutorial: https://lnkd.in/eeaVxPvT #TQTwaiver #TQTsubstitution #ECGcorelab #CPTJournal #ASCPTJournalFamily
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Final FDA guidance for Oligonucleotide drug development recommends QT prolongation risk assessment, immunogenicity assay development, and evaluation of hepatic & renal impaired patients. FDA guidance: https://lnkd.in/g2EmpR8p Read our blog: https://lnkd.in/egviY3vA #RNA #OligonucleotideTherapies #ClinicalDrugDevelopment
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