Population Pharmacokinetics of the Antituberculosis Agent Pretomanid-Reference-Cited by-同舟云学术

Population Pharmacokinetics of the Antituberculosis Agent Pretomanid

Published:2019-10 Issue:10 Volume:63 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Salinger David H.¹,Subramoney Vishak¹,Everitt Daniel²,Nedelman Jerry R.²

Affiliation:

1. Certara, Inc., Princeton, New Jersey, USA

2. TB Alliance, New York, New York, USA

Abstract

A population pharmacokinetic (PopPK) model for pretomanid was developed using data from 14 studies in the pretomanid development program: six phase 1 studies, six phase 2 studies, and two phase 3 studies. The final analysis data set contained 17,725 observations from 1,054 subjects, including healthy subjects and subjects with drug-sensitive, multidrug-resistant, or extensively drug-resistant pulmonary tuberculosis dosed pretomanid in monotherapy or combination therapy for up to 6 months.

Funder

Bill and Melinda Gates Foundation

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.00907-19

Reference24 articles.

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3. Dawson R, Harris K, Conradie A, Burger D, Murray S, Mendel C, Spigelman M. 2017. Efficacy of bedaquiline, pretomanid, moxifloxacin, and PZA (BPaMZ) against DS- and MDR-TB. Abstracts of the Conference on Rotoviruses and Opportunistic Infections, abstr 724-LB. http://www.croiconference.org/sessions/efficacy-bedaquiline-pretomanid-moxifloxacin-pza-bpamz-against-ds-mdr-tb.

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5. FDA. 2019. Guidance for industry: population pharmacokinetics. U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Bethesda, MD.

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