Evidence map›Paper›PMID 40965470›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir.

Bu-Fan Yao, Yang Yang, Shan-Sen Xu, Bo-Hao Tang, Jia Chen, Zi-Jia Guo, Hong-Lin Hu, Wei Zhang, Shu-Meng Fu, Xin-Fang Zhang and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Bu-Fan Yao *Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Yang Yang *Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Shan-Sen XuState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Bo-Hao TangDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Jia ChenState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Zi-Jia GuoState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Hong-Lin HuState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Wei ZhangDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Shu-Meng FuDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Xin-Fang ZhangDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Guo-Xiang HaoDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.ORCID 0000-0003-4847-091X
Xin-Mei YangDepartment of Clinical Pharmacy, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Shandong Medicine and Health Key Laboratory of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
Lin-Lin SongDepartment of Clinical Pharmacy, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Shandong Medicine and Health Key Laboratory of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
Pan-Pan YeDepartment of Clinical Pharmacy, Shandong Engineering and Technology Research Center for Pediatric Drug Development, Shandong Medicine and Health Key Laboratory of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
Lian LiuState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Shun-Wei ZhuState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China.
Yi Zheng *Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.
Wei Zhao *Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.ORCID 0000-0002-1830-338X

Funding

Distinguished Young and Middle-aged Scholar of Shandong UniversityNational Key R&D Program of China 2023YFC2706100Natural Science Foundation of Jiangsu Province BK20210003Taishan Scholar Program of Shandong Province tstp20230660
6 · The paper itself

Abstract

During a Public Health Emergency of International Concern (PHEIC), rapid drug development is critical, but traditional clinical trials are time-consuming and high-risk. This study used coronavirus disease 2019 (COVID-19) as an example to highlight the pivotal role of model-informed drug development (MIDD) in expediting the marketing authorization of simnotrelvir in China, a 3CL

Indexed as

Antiviral AgentsCOVID-19 Drug TreatmentDrug DevelopmentChinaCOVID-19HumansMonte Carlo MethodRitonavirSARS-CoV-2Antiviral AgentsRitonavirexposure-response analysismodel-informed drug developmentnonlinear mixed-effects modelOmicron variantpublic health emergencysimnotrelvir

Identifiers

PMID40965470
PMCPMC12587539

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.