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Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...

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Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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UHPLC-MS-Based Analysis of Fluvoxamine in Rabbit Aqueous Humour and Serum: Method Development and Validation.

Andrea Guba1,2, Anna Takácsi-Nagy3, Sourav Das4,5

  • 1Proteomics Core Facility, Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Debrecen, Egyetem tér 1, 4032 Debrecen, Hungary.

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|February 27, 2026
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Summary

Fluvoxamine (FLU) shows promise for glaucoma treatment. A new UHPLC-MS method accurately measures FLU in eye fluid and blood, crucial for developing effective and safe FLU eyedrops.

Keywords:
EMA guidelinesUHPLC-MS methodaqueous humourfluvoxamineserumsigma-1 receptor

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Area of Science:

  • Pharmacology
  • Ophthalmology
  • Analytical Chemistry

Background:

  • Fluvoxamine (FLU), a selective serotonin reuptuptake inhibitor and sigma-1 receptor agonist, demonstrates organ-protective effects.
  • FLU eyedrops offer a potential new therapy for glaucoma, addressing unmet clinical needs with potentially fewer side effects than current treatments.

Purpose of the Study:

  • To develop and validate a precise quantification method for FLU in ocular tissues and serum.
  • To support the development of FLU eyedrops for glaucoma by characterizing drug absorption, bioavailability, and safety.

Main Methods:

  • Development and validation of a UHPLC-MS/MS method for FLU detection.
  • Utilized simple sample preparation techniques for aqueous humor and serum analysis.
  • Employed reverse-phase chromatography and SRM-based mass spectrometry.

Main Results:

  • The validated UHPLC-MS method is highly selective and sensitive for FLU detection.
  • The method demonstrated linearity within the 0.0625-1.5 µg/mL range and met EMA validation guidelines.
  • Minimal matrix effects were observed, simplifying sample analysis.

Conclusions:

  • The developed method is robust, simple, and suitable for preclinical pharmacokinetic and pharmacodynamic studies of FLU.
  • This analytical tool is essential for advancing the development of FLU-based ocular therapies for glaucoma.