Michael Vogeser
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View article: Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview
Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview Open
Process chains in medical diagnostic laboratories lead to an accurate diagnosis and consequently to optimized personalized therapy recommendations. In addition to approved commercial in vitro diagnostic medical devices, devices and tests m…
View article: First therapeutic drug monitoring of experimental favipiravir in Borna disease virus 1 (BoDV-1) encephalitis patients reveals significant gaps in antiviral treatment: a pilot investigation
First therapeutic drug monitoring of experimental favipiravir in Borna disease virus 1 (BoDV-1) encephalitis patients reveals significant gaps in antiviral treatment: a pilot investigation Open
Background The Borna disease virus 1 (BoDV-1) causes a rare, but severe form of encephalitis in Germany, characterized by rapid progression, late diagnosis, and a high case fatality. Therapy is experimental and recommendations are lacking.…
View article: Therapeutic Drug Monitoring von CDK4/6-Inhibitoren mittels LC-MS/MS: Auf dem Weg zur personalisierten Therapie
Therapeutic Drug Monitoring von CDK4/6-Inhibitoren mittels LC-MS/MS: Auf dem Weg zur personalisierten Therapie Open
CDK4/6-Inhibitoren kommen in der Therapie bestimmter Formen von Brustkrebs zum Einsatz. Unerwünschte Arzneimittelinteraktionen, Polypharmazie und auch Resistenzen gegen die Wirkstoffe stellen bei der Behandlung von Mammakarzinomen eine gro…
View article: Evaluation of the detuning ratio as a tool to detect potential interference in LC-MSMS analysis
Evaluation of the detuning ratio as a tool to detect potential interference in LC-MSMS analysis Open
It was confirmed that a DR can be used as a method to obtain indications of the presence of isomeric or isobaric interferences in individual samples in an analytical LC-MS/MS system; the technique can be used in addition to the established…
View article: Patientensicherheit durch Qualitätssicherung in der In-vitro-Diagnostik – Webinar 2024 der Ad-hoc-Kommission In-vitro-Diagnostik der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)
Patientensicherheit durch Qualitätssicherung in der In-vitro-Diagnostik – Webinar 2024 der Ad-hoc-Kommission In-vitro-Diagnostik der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) Open
The reliability of laboratory tests is ensured in particular by the interaction of regulated market access and certification of diagnostics, scientific evidence through guidelines, the guideline of the German Medical Association on quality…
View article: Optimizing phenobarbital dosing in critically ill patients with refractory and superrefractory status epilepticus using a population pharmacokinetic model
Optimizing phenobarbital dosing in critically ill patients with refractory and superrefractory status epilepticus using a population pharmacokinetic model Open
Objective Current weight‐based dosing fails to account for pharmacokinetic variability in refractory and superrefractory status epilepticus (RSE, SRSE). However, understanding pharmacokinetics in critically ill patients with varying degree…
View article: Clinical value of circulating bioactive adrenomedullin for prediction of outcome and hydrocortisone response in sepsis patients—a post-hoc analysis of the HYPRESS trial
Clinical value of circulating bioactive adrenomedullin for prediction of outcome and hydrocortisone response in sepsis patients—a post-hoc analysis of the HYPRESS trial Open
Purpose Sepsis requires stratification for host-directed therapies through the discovery of adequate biomarkers enabling prediction of outcomes and treatment responses. Adrenomedullin has previously demonstrated potential for prognostic en…
View article: Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study
Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study Open
gov/ct2/show/study/NCT03985605.
View article: A Liquid Chromatography-Tandem Mass Spectrometry Method for the Quantification of Cystic Fibrosis Drugs (Caftors) in Plasma and Its Application for Therapeutic Monitoring
A Liquid Chromatography-Tandem Mass Spectrometry Method for the Quantification of Cystic Fibrosis Drugs (Caftors) in Plasma and Its Application for Therapeutic Monitoring Open
Cystic fibrosis (CF) is a life-threatening disorder caused by mutations in the CFTR gene, leading to defective chloride ion transport and thickened mucus in the respiratory and gastrointestinal systems. CFTR modulators, including ivacaftor…
View article: Medizinische Labordiagnostik in Deutschland – ein Statusbericht 2024
Medizinische Labordiagnostik in Deutschland – ein Statusbericht 2024 Open
Background and aim of the work: Laboratory diagnostics (in-vitro diagnostics, IVD) is one of the main pillars of evidence-based medicine; for many medical fields – such as endocrinology – laboratory tests are conditional, but not indispens…
View article: A Liquid Chromatography-Tandem Mass Spectrometry Method for the Quantification of Cystic Fibrosis Drugs (Caftors) in Plasma and Its Application for Therapeutic Monitoring
A Liquid Chromatography-Tandem Mass Spectrometry Method for the Quantification of Cystic Fibrosis Drugs (Caftors) in Plasma and Its Application for Therapeutic Monitoring Open
Cystic fibrosis (CF) is a life-threatening disorder caused by mutations in the CFTR gene, leading to defective chloride ion transport and thickened mucus in the respiratory and gastrointestinal systems. CFTR modulators, including ivacaftor…
View article: Lactate Clearance of the Adsorber Cytosorb® in Critically Ill Patients: A Post-Hoc Analysis of the Cyto-SOLVE Trial
Lactate Clearance of the Adsorber Cytosorb® in Critically Ill Patients: A Post-Hoc Analysis of the Cyto-SOLVE Trial Open
Background/Objectives: Patients with shock suffer from hyperlactatemia, which can lead to endothelial dysfunction. The use of the adsorber Cytosorb® (CS) is recommended in these patients as it may contribute to higher lactate clearance and…
View article: Von der Evidenz in die Versorgung: Chancen und Risiken für Gesundheits- und Wissenschaftspolitik. Ein Positionspapier der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)
Von der Evidenz in die Versorgung: Chancen und Risiken für Gesundheits- und Wissenschaftspolitik. Ein Positionspapier der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) Open
Objective: After over 25 years of developing clinical practice guidelines, the Association of the Scientific Medical Societies in Germany (AWMF) held a symposium to discuss the following topics in order to improve the way evidence is imple…
View article: Therapeutic Drug Monitoring of Elexacaftor, Tezacaftor, and Ivacaftor in Adult People with Cystic Fibrosis
Therapeutic Drug Monitoring of Elexacaftor, Tezacaftor, and Ivacaftor in Adult People with Cystic Fibrosis Open
Background/Objectives: Elexacaftor, tezacaftor, and ivacaftor (ETI) have significantly improved lung function in people with cystic fibrosis (pwCF). Despite exceptional improvements in most cases, treatment-related inter-subject variabilit…
View article: Research letter: Pilot study of a prototype fully automated mass spectrometry system for routine clinical laboratory use
Research letter: Pilot study of a prototype fully automated mass spectrometry system for routine clinical laboratory use Open
View article: Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika
Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika Open
Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation …
View article: Standardization via Post Column Infusion—A Novel and Convenient Quantification Approach for LC-MS/MS
Standardization via Post Column Infusion—A Novel and Convenient Quantification Approach for LC-MS/MS Open
Mass spectrometry (MS) is a widely used analytical technique including medical diagnostics, forensic toxicology, food and water analysis. The gold standard for quantifying compounds involves using stable isotope-labeled internal standards …
View article: Understanding isotopes, isomers, and isobars in mass spectrometry
Understanding isotopes, isomers, and isobars in mass spectrometry Open
Mass spectrometry (MS) is a versatile analytical tool used in various fields such as biochemistry, pharmacology, omics, and clinical analysis for determining and quantifying compounds based on their molecular mass and structure through the…
View article: Isotope-dilution-LC-MS/MS candidate reference measurement procedure for cefepime in human serum
Isotope-dilution-LC-MS/MS candidate reference measurement procedure for cefepime in human serum Open
The novel isotope-dilution-LC-MS/MS measurement procedure in accordance to ISO 15193 can be recommended as candidate reference measurement procedure for the value assignment of cefepime concentrations in human serum.
View article: Meropenem pharmacokinetics in cerebrospinal fluid: comparing intermittent and continuous infusion strategies in critically ill patients—a prospective cohort study
Meropenem pharmacokinetics in cerebrospinal fluid: comparing intermittent and continuous infusion strategies in critically ill patients—a prospective cohort study Open
Meropenem penetration into the cerebrospinal fluid (CSF) is subject to high interindividual variability resulting in uncertain target attainment in CSF. Recently, several authors recommended administering meropenem as a continuous infusion…
View article: Spuriously low immunosuppressant results due to incomplete hemolysis – A pitfall in transplant patient therapeutic drug monitoring
Spuriously low immunosuppressant results due to incomplete hemolysis – A pitfall in transplant patient therapeutic drug monitoring Open
View article: Can linezolid be validly measured in endotracheal aspiration in critically ill patients? A proof-of-concept trial
Can linezolid be validly measured in endotracheal aspiration in critically ill patients? A proof-of-concept trial Open
Background Therapeutic drug monitoring (TDM) of anti-infectives such as linezolid is routinely performed in blood of intensive care unit (ICU) patients to optimize target attainment. However, the concentration at the site of infection is c…
View article: Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung – Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023
Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung – Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023 Open
In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.…
View article: Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword
Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword Open
Objectives Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for …
View article: Is commutability of a reference material always desirable?
Is commutability of a reference material always desirable? Open
View article: Extracorporeal adsorption of protective and toxic bile acids and bilirubin in patients with cholestatic liver dysfunction: a prospective study
Extracorporeal adsorption of protective and toxic bile acids and bilirubin in patients with cholestatic liver dysfunction: a prospective study Open
View article: Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology
Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology Open
View article: Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie
Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie Open
View article: Competence-based catalog of learning objectives for the subject area of quality management in medical studies – position paper of the working group Quality Management in Education, Training and Continuing Education of the Society for Quality Management in Health Care (GQMG)
Competence-based catalog of learning objectives for the subject area of quality management in medical studies – position paper of the working group Quality Management in Education, Training and Continuing Education of the Society for Quality Management in Health Care (GQMG) Open
Background: Traditionally, direct medical competences are taught in medical studies, whereas leadership and quality management competences are hardly taught, although graduates are already confronted with management tasks at the beginning …
View article: Frontmatter
Frontmatter Open
Evaluation of