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Tandem mass spectrometry is a technique that uses multiple mass analyzers in series to obtain a higher selectivity and reduce chemical noise during analyte detection. Instruments with multiple analyzers separated by an interaction cell enable secondary fragmentation and selected study of the fragment ions.Secondary fragmentations occur in the interaction cell and can be induced by various factors. Fragmentation induced by collision with inert gases, such as N2, Ar, He, etc., is called...
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Tandem mass spectrometry, also known as MS/MS or MS2, is an analytical technique that employs two mass analyzers. Essentially it is a series of mass spectrometers that helps isolate a particular biomolecule and then helps study its chemical properties.
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Mass spectrometry is a powerful characterization technique that can identify and separate a wide variety of compounds ranging from chemical to biological entities, based on their mass-to-charge ratio (m/z). The instruments that allow this detection, known as mass spectrometers, have three components: an ion source, a mass analyzer, and a detector. These spectrometers differ based on the nature of their ion source and analyzers.Matrix-assisted laser desorption ionization (MALDI) is a commonly...
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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Adding value through accelerator mass spectrometry-enabled first in human studies.

Mark A Seymour1

  • 1PharMAS Consulting, Harrogate, UK.

Journal of Labelled Compounds & Radiopharmaceuticals
|July 23, 2016
PubMed
Summary

Accelerator mass spectrometry (AMS) offers ultra-sensitive radiocarbon analysis for bioanalysis. This technique enhances early clinical studies by providing crucial pharmacokinetic and metabolic data, improving drug development efficiency.

Keywords:
AMSabsolute bioavailabilityaccelerator mass spectrometryhuman in vivo dispositionintravenous pharmacokineticsmicrotracer

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Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Biotechnology

Background:

  • Accelerator mass spectrometry (AMS) is a highly sensitive method for radiocarbon analysis.
  • It is applicable to various sample types and 14C-labelled analytes in bioanalysis.
  • LC+AMS methodology is robust, reliable, and meets conventional bioanalytical validation criteria.

Purpose of the Study:

  • To discuss the application of AMS in enhancing first in human (FIH) clinical studies.
  • To highlight the generation of significant additional data through AMS.
  • To demonstrate the cost-effectiveness and time-saving benefits of AMS in drug development.

Main Methods:

  • Utilizing 14C-labelled microtracer doses administered concurrently with pharmacologically relevant non-radiolabelled doses.
  • Employing liquid chromatography coupled with accelerator mass spectrometry (LC+AMS) for ultra-sensitive analysis.
  • Leveraging AMS's tracer capabilities to differentiate administered radiolabel from endogenous compounds.

Main Results:

  • AMS enables the determination of fundamental pharmacokinetics (clearance and volume of distribution), absolute bioavailability, and mass balance.
  • It facilitates detailed analysis of excretion routes and rates, metabolic fate, and tissue disposition.
  • The method provides reliable human in vivo data early in development, preventing later-stage expenditure.

Conclusions:

  • AMS significantly enhances FIH study design by providing comprehensive pharmacokinetic and metabolic insights.
  • The use of 14C-labelled microtracer doses with AMS is a cost-effective and time-efficient approach.
  • This methodology supports informed decision-making in drug development, reducing overall costs and timelines.