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Drug Induced Liver Injury in Premarketing Clinical Trials

WebDILI (Drug Induced Liver Injury) is a rare but potentially fatal adverse drug reaction. DILI is a very common cause of acute liver failure in North America and Europe, a key reason for the failure of a drug to …

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URL: https://soterius.com/drug-induced-liver-injury-in-premarketing-clinical-trials/

Medical Affairs Solutions

WebVirtual Medical Science Liaison Platform. Unique platform that allows Health Care Professionals to connect with medical and commercial colleagues in a compliant …

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Causality Assessment in Pharmacovigilance

WebThis is a combined assessment considering the clinical-pharmacological aspects of the case and the quality of documentation of the observation. The main …

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Are ALT & AST Elevations Really Liver Function Tests

WebTherefore, the term Liver function tests (LFTs) being used for elevations of ALT and AST is somewhat of a misnomer because these enzymes do not represent liver function, but rather indicate the damage of liver cells. On the other hand, albumin, bilirubin, and vitamin K-dependent clotting factors represent synthetic function of the liver.

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Clients Love our Pharmacovigilance and Drug Safety

WebClinical Safety Services. We provide end to end services to support clinical stage products portfolio of our clients as a centralized pharmacovigilance operation, integrating clinical …

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Medical Affairs Services

WebTechnological Innovations. Soterius is a leader in digital innovation, having developed a fit for purpose virtual platform to connect you with HCPs at a time and manner of their …

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Medication Errors Why is it Important to Record, Assess, and …

WebThe Figure below reflects the interplay between medication errors and harm (i.e. associated with adverse reaction and preventability). Adverse reactions that result from medication errors are considered preventable, in contrast to generally non-preventable adverse reactions which are mentioned in the Product Label (e.g. in Prescribing Information, …

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Clients Love our Pharmacovigilance and Drug Safety Outsourced …

WebPost Marketed Safety Services. Conducting large scale operations for global pharmaceutical companies that require hundreds of staff in specific processes, to small and mid-size …

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Medication Errors

WebStrategies for Reducing Medication Errors Various mechanisms can be employed to reduce the occurrence of medication errors. The FDA is actively involved in efforts to prevent …

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Medical Affairs Services

WebWe look forward to participating in the DIA Pharmacovigilance and Risk Management Strategies Conference, February 05-07, 2024! You can talk to our experts at Booth #310 …

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Quality Assurance

WebQuality Assurance Soterius, Inc. is a trusted provider of GxP-compliant clinical and post-market safety services, with a strong focus on pharmacovigilance.

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Explore Decentralized Medical Insights Blogs

WebDrug Induced Liver Injury in Premarketing Clinical Trials DILI (Drug Induced Liver Injury) is a rare but potentially fatal adverse drug reaction. DILI is a Explore Decentralized …

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Soterius Attendance at Breakthrough 2023

WebWe are Soterius – a strong team of experienced professionals from the pharma industry. We design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence with big data in pioneering …

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