Evidence map›Paper›PMID 37130653›Full record

ReviewBMJ paediatrics open2023

Regulatory considerations for paediatric drug evaluation in China.

Ying Geng, Qiang Li, Yan-Zhe Sun, Hao Zhang, Yong-Lin Jiang, Li-Qing Wang, Yue-E Wu, Wei Zhao, Zhi-Min Yang

Abstract readReview
In one paragraph

Review in BMJ paediatrics open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

9 authors.

Ying GengCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Qiang LiCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Yan-Zhe SunCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Hao ZhangCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Yong-Lin JiangCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Li-Qing WangCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China.
Yue-E WuDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China.
Wei ZhaoDepartment of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China yangzhm@cde.org.cn zhao4wei2@hotmail.com.ORCID 0000-0002-1830-338X
Zhi-Min YangCentre for Drug Evaluation, National Medical Products Administration, Beijing, People's Republic of China yangzhm@cde.org.cn zhao4wei2@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The regulatory guidelines for the research and development of paediatric drugs are still evolving in China. The formulation of the guidelines started from learning and borrowing existing experience, and gradually changed to the exploration and improvement of local guidelines, which was not only in line with international standards but also had breakthroughs, innovations and Chinese characteristics. In this paper, the current setting of paediatric drug research and development in China and corresponding technical guidelines have been introduced from regulatory perspectives, and the accessibility of further improvement in regulatory strategies has also been discussed.

Indexed as

Drug EvaluationChildChinaHumansReference StandardsPharmacology

Identifiers

PMID37130653
PMCPMC10163445

What OpenQuestion holds

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LicenceCC BY-NC
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 OpenQuestion graph.