Today we have announced that the FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis. $TLSA #MultipleSclerosis #MS #SPMS #Foralumab #FDA https://lnkd.in/e7NcdTry
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In this K-Cast series, experts discuss adverse effects of anti-fibrotic agents and examine pharmacotherapies for IPF that are currently in phase 3 clinical trials. Watch this program to learn more about the unmet needs with IPF treatment and the future of IPF management. https://bit.ly/3VYeOSZ #ManagedCare
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The identification and management of patients at high bleeding risk (HBR) undergoing TAVI are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI. Philippe GAROT https://ow.ly/mYNi50S3PKh
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The #FDA has finalised its rule on laboratory developed tests (#LDTs), marking a significant shift in medical diagnostics regulation. Discover the key changes and implications for the industry in our latest blog post. PeploBio's regulatory experts are here to guide you through this transition and ensure compliance. Learn more: https://lnkd.in/eZs24r_8 #FDARegulation #MedicalDiagnostics #LDTs #RegulatoryCompliance #HealthcareIndustry #Diagnostics #MedicalDevices #FDAApproval #LabTesting #ComplianceSupport
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The identification and management of patients at high bleeding risk (HBR) undergoing TAVI are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI. https://lnkd.in/e6Ri8Wez
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There was an incredible superstar line-up of presentations and speakers at the The Institute for Functional Medicine #AIC2024. One panel discussion stands out because included a multidisciplinary panel - MD, ND, APRN, and a PharmD 🙌🏽 Here are the top 3 things I learned about GLP-1s that I think are wroth highlighing: ✨️ Topical compounded metformin can be a great alternative in patients with GI side effects ✨️ Studies have shown reduced inflammation, lower Nf-kB and as much as a 30% reduction in hsCRP ✨️ When we're working on weight loss and actively trying to mitigate muscle loss, sure protein has to be a priority, but the conversation has to also include fiber and behavior change. Truely a great discussion, and FWIW I really loved the format 🤓👏🏽 👉🏽 What have you been seeing in your patients on GLP-1? Shilpa P. Saxena MD Michelle Leary Monique Class, MS, APRN-BC Melody Hartzler #FxMed #integrativemedicine #glp1 #pharmacist
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Evaluate how much medication is required to start and maintain enrolment. Predict how long medication will last. Determine optimal buffer stock needed. And reduce excessive drug wastage. All with Calyx’s Supply Simulation service. https://lnkd.in/gBAT667D #IRT #RTSM #TrialSupplyManagement #ChooseCalyx #IRT #RTSM #clinicalresearch #DiscoverCalyx
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Caitlyn Durgin will present this poster on the development of new #analgesics at CPDD. Clinically meaningful efficacy and safety profiles could help meet the critical unmet medical and public health need for new therapies to treat #pain and improve emotional and physical functioning, and quality of life. Clinical development plans responsive to FDA guidance anticipate the need for rigorous assessment of abuse-related adverse events for drugs that have #CNS activity, novel endpoint evaluation, and potential inclusion of combination therapy approaches. #CPDD24 #AdverseEvents #ClinicalTrials #clinicaldevelopment #FDA
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UPDATE: Sequence2Script now includes activity scores for CYP2C9, CYP2D6, and DPYD. Activity scores are calculated according to guidelines published by the Clinical Pharmacogenetics Implementation Consortium.
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Statistical Programmer 2 at Fortrea: Driving Data-Driven Insights and Advancing Healthcare through Advanced Analytics
Difference between RFSTDTC, RFENDTC and 𝐑𝐅𝐗𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐗𝐄𝐍𝐃𝐓𝐂 𝐑𝐅𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐄𝐍𝐃𝐓𝐂 indicate a patient's initial and final exposure to a study drug or treatment, crucial for analyzing patient involvement and events within the study. They are expected to be populated for all randomized subjects, as they denote the beginning and end of a patient's exposure to the study drug. However, understanding the patient's study involvement timeline is crucial for event analysis. In some studies, the reference period starts to vary due to factors like washout periods or required medical procedures during screening. In such cases, RFSTDTC defaults to the enrollment date. For studies where many subjects aren't expected to be treated, a different milestone may serve as the starting reference point. RFSTDTC (and RFENDTC) will be null only if a subject experiences screen failure, isn't assigned to a treatment arm, or is randomized but doesn't receive treatment. 𝐑𝐅𝐗𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐗𝐄𝐍𝐃𝐓𝐂 variables specifically represent the date and time of the first and last study exposure to the protocol-specified treatment or therapy, respectively. These values are consistent with those from SDTM.EX sources.
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A co-located Phase I unit and bioanalytical lab is a major Celerion asset. This affords tremendous opportunities for FIH/Phase I studies requiring fast processing/analysis of samples. Studies employing time critical Flow and/or EliSpot assays are standout beneficiaries. It can also help reduce dose escalation timelines if PK or other data is needed - no shipping time to consider.
A co-located Clinic and Bioanalytical lab allows for robust PBMC sample integrity, immediate sample analysis & saves on shipping costs. Learn more about what our site in Lincoln, NE has to offer: https://lnkd.in/eQ5f88Jb Learn more about our bioanalytical services: https://lnkd.in/g2B35hU2 #BioanalyticalInnovation #HealthcareEfficiency #LabLife #MedicalResearch
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