Evidence map›Paper›PMID 41655132›Full record

ArticleCPT: pharmacometrics & systems pharmacology2026

Quantitative Evaluation of Model-Informed Drug Development Implementation in China's Approved Innovative Drugs: From Policy to Practice (2018-2024).

Jian Li, Zhenlei Wang, Chunmin Wei, Ruirui He, Qingyu Yao

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

5 authors.

Jian LiCenter of Drug Evaluation, National Medical Products Administration, Beijing, China.
Zhenlei WangNMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, Chengdu, China.
Chunmin WeiCenter of Drug Evaluation, National Medical Products Administration, Beijing, China.
Ruirui HeCenter of Drug Evaluation, National Medical Products Administration, Beijing, China.
Qingyu YaoDrug Clinical Trial Institution, Beijing Key Laboratory of Clinical Pharmacology and Translation of Innovative Drugs, Peking University First Hospital, Beijing, China.ORCID https://orcid.org/0009-0004-2051-3134

Funding

National Natural Science Foundation of China 82204510State Key Laboratory of Drug Regulatory Science Project 2023SKLDRS0147
6 · The paper itself

Abstract

Model-informed drug development (MIDD) has emerged as a cornerstone paradigm in global pharmaceutical innovation. Historically underutilized in China, MIDD methodologies gained momentum following the National Medical Products Administration's (NMPA) 2020 release of the Model-Informed Drug Development Technical Guideline, which was subsequently augmented by supplementary technical guidelines to systematically promote and institutionalize MIDD adoption. This study conducts a longitudinal analysis of MIDD implementation in China-approved innovative drugs from 2018 to 2024, spanning pre- and post-guideline eras.

Indexed as

Drug ApprovalDrug DevelopmentModels, BiologicalChinaHumansexposure responsemodel informed drug developmentphysiology‐based pharmacokineticspopulation pharmacokinetics

Identifiers

PMID41655132
PMCPMC12883143

What OpenQuestion holds

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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 OpenQuestion graph.