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Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

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Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
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Related Experiment Video

Updated: Nov 6, 2025

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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S-Carboxymethyl-l-cysteine: a multiple dosing study using pharmacokinetic modelling.

Glyn B Steventon1, Stephen C Mitchell2

  • 1ADMET Solutions Ltd, Basingstoke, UK.

Xenobiotica; the Fate of Foreign Compounds in Biological Systems
|May 11, 2021
PubMed
Summary
This summary is machine-generated.

S-Carboxymethyl-l-cysteine (SCMC) concentrations achieved in patients are generally lower than those required for many proposed mechanisms of action. This suggests that only gene-related effects observed in vitro are likely relevant in vivo.

Keywords:
S-Carboxymethyl-l-cysteinepharmacodynamicspharmacokineticspharmacometric modelling

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Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Respiratory Medicine
  • Drug Metabolism and Disposition

Background:

  • S-Carboxymethyl-l-cysteine (SCMC) is a mucolytic agent used in respiratory disorders.
  • Proposed mechanisms of action often lack correlation with in vivo concentrations.
  • Understanding the in vitro-in vivo relationship is crucial for accurate drug mechanism assessment.

Purpose of the Study:

  • To re-analyze existing data on SCMC pharmacokinetics.
  • To compare in vitro effective concentrations with in vivo achieved concentrations.
  • To evaluate the clinical relevance of proposed SCMC mechanisms of action.

Main Methods:

  • Re-analysis of published data using WinNonlin software.
  • Application of non-compartmental and compartmental pharmacokinetic modeling.
  • Modeling for single and multiple oral SCMC administrations.

Main Results:

  • Maximum peak (Cmax) and steady-state average (Css(av)) concentrations were determined for various doses.
  • For a standard regimen (2250 mg/day), Cmax ranged from 1.29-5.22 μg/ml and Css(av) from 1.30-3.50 μg/ml.
  • No drug accumulation was observed; in vivo concentrations rarely exceeded 10 μg/ml.

Conclusions:

  • Pharmacodynamic studies requiring concentrations below ~10 μg/ml are most likely relevant in vivo.
  • Gene-related mechanisms are the primary plausible in vivo effects of SCMC.
  • Discrepancies between in vitro and in vivo concentrations can lead to erroneous conclusions about drug mechanisms.