Translational Model-Informed Approach for Selection of Tuberculosis Drug Combination Regimens in Early Clinical Development.
Antibiotics, Antitubercular
/ administration & dosage
Antitubercular Agents
/ administration & dosage
Bacterial Load
Clinical Trials, Phase II as Topic
Drug Development
Drug Dosage Calculations
Drug Therapy, Combination
Humans
Isoniazid
/ administration & dosage
Microbial Sensitivity Tests
Models, Biological
Mycobacterium tuberculosis
/ drug effects
Rifampin
/ administration & dosage
Translational Research, Biomedical
Tuberculosis
/ drug therapy
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
30
08
2019
accepted:
08
02
2020
pubmed:
23
2
2020
medline:
25
5
2021
entrez:
22
2
2020
Statut:
ppublish
Résumé
The development of optimal treatment regimens in tuberculosis (TB) remains challenging due to the need of combination therapy and possibility of pharmacodynamic (PD) interactions. Preclinical information about PD interactions needs to be used more optimally when designing early bactericidal activity (EBA) studies. In this work, we developed a translational approach which can allow for forward translation to predict efficacy of drug combination in EBA studies using the Multistate Tuberculosis Pharmacometric (MTP) and the General Pharmacodynamic Interaction (GPDI) models informed by in vitro static time-kill data. These models were linked with translational factors to account for differences between the in vitro system and humans. Our translational MTP-GPDI model approach was able to predict the EBA
Substances chimiques
Antibiotics, Antitubercular
0
Antitubercular Agents
0
Isoniazid
V83O1VOZ8L
Rifampin
VJT6J7R4TR
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
274-286Subventions
Organisme : Medical Research Council
ID : MR/T016426/1
Pays : United Kingdom
Informations de copyright
© 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
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