{"title":"ema批准的抗真菌药物开发过程中的临床前药代动力学/药效学研究和临床试验综述","authors":"Theresa Pecho, Markus Zeitlinger","doi":"10.1007/s40262-023-01327-2","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":10405,"journal":{"name":"Clinical Pharmacokinetics","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10786742/pdf/","citationCount":"0","resultStr":"{\"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\",\"doi\":\"10.1007/s40262-023-01327-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":10405,\"journal\":{\"name\":\"Clinical Pharmacokinetics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10786742/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Pharmacokinetics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40262-023-01327-2\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/11/16 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Pharmacokinetics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40262-023-01327-2","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/16 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review.
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.
期刊介绍:
Clinical Pharmacokinetics promotes the continuing development of clinical pharmacokinetics and pharmacodynamics for the improvement of drug therapy, and for furthering postgraduate education in clinical pharmacology and therapeutics.
Pharmacokinetics, the study of drug disposition in the body, is an integral part of drug development and rational use. Knowledge and application of pharmacokinetic principles leads to accelerated drug development, cost effective drug use and a reduced frequency of adverse effects and drug interactions.