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Open Access 16-11-2023 | Candidiasis | Review Article

Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review

Authors: Theresa Pecho, Markus Zeitlinger

Published in: Clinical Pharmacokinetics | Issue 1/2024

Abstract

Antifungal drug development is essential as invasive fungal disease is still associated with a very high mortality rate and the emergence of resistant species in the last decade. In Europe, the European Medical Agency (EMA) approves antifungals and publishes the European Public Assessment Report (EPAR) including the information leading up to the authorisation. We looked at EMA-approved antifungals and their reports within the last 23 years. We focused primarily on the role of pharmacokinetic/pharmacodynamic indices in antifungal development and the level of information depicted in their corresponding report. Furthermore, we investigated guidelines applicable to the development process at the time and compared the content with a focus on pharmacokinetic/pharmacodynamic studies and preclinical requirements. Since 2000, six new antifungal substances have been authorised. Most were authorised for treatment of Candida infections or Aspergillus infections but also included rarer pathogens. Pharmacokinetic/pharmacodynamic indices were scarcely investigated and/or mentioned in the report. Current antifungal EMA guidelines started emphasising investigating pharmacokinetic/pharmacodynamic indices in 2010 and then again in 2016. It remains to be seen how this translates into the authorisation process for new antifungals.

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Title: Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review
Authors: Theresa Pecho
Markus Zeitlinger
Publication date: 16-11-2023
Publisher: Springer International Publishing
Keywords: Candidiasis
Candidiasis
Voriconazole
Micafungin
Caspofungin
Published in: Clinical Pharmacokinetics / Issue 1/2024
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI: https://doi.org/10.1007/s40262-023-01327-2

At a glance: The STEP trials

Springer Medicine

Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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