Evidence map›Paper›PMID 31163633›Full record

ArticlePharmaceutics2019

Application of Size and Maturation Functions to Population Pharmacokinetic Modeling of Pediatric Patients.

Hyun-Moon Back, Jong Bong Lee, Nayoung Han, Sungwoo Goo, Eben Jung, Junyeong Kim, Byungjeong Song, Sook Hee An, Jung Tae Kim, Sandy Jeong Rhie and 4 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
–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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

14 authors.

Hyun-Moon BackDepartment of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA. hyunmoon.back@rutgers.edu.
Jong Bong LeeDepartment of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA. jongbong.lee@rutgers.edu.
Nayoung HanCollege of Pharmacy, Seoul National University, Gwanak-ro 1, Gwanakgu, Seoul 08826, Korea. hans1217@snu.ac.kr.
Sungwoo GooCollege of Pharmacy, Chungnam National University, Daehak-ro 99, Yuseonggu, Daejeon 34134, Korea. swgoo@cnu.ac.kr.
Eben JungMinistry of Food and Drug Safety, Osongsangmyung 2-ro 187, Cheongju, Chungbuk 28159, Korea. ebjung@korea.kr.ORCID 0000-0001-6614-3045
Junyeong KimCollege of Pharmacy, Chungnam National University, Daehak-ro 99, Yuseonggu, Daejeon 34134, Korea. jyeongkim@cnu.ac.kr.
Byungjeong SongJW Pharmaceutical Corp., Drug Discovery Center, Nambusunhwan-ro 2477, Seochogu, Seoul 06725, Korea. bjsong@jw-pharma.co.kr.
Sook Hee AnCollege of Pharmacy, Wonkwang University, Iksandae-ro 460, Iksan, Jeonbuk 54538, Korea. shan7@wku.ac.kr.
Jung Tae KimDepartment of Pharmacy, Kyunghee University Hospital at Gang-dong, Dongnam-ro 892, Kangdonggu, Seoul 05278, Korea. jtkim@khnmc.or.kr.
Sandy Jeong RhieCollege of Pharmacy, Ewha Womans University, Ewhayeodae-gil 52, Seoul 03760, Korea. sandy.rhie@ewha.ac.kr.
Yoon Sun ReeDepartment of Pharmacy, Yonsei University Health System, Yonsei-ro 50-1, Seodaemun-gu, Seoul 03722, Korea. YOONSUN@yuhs.ac.
Jung-Woo ChaeCollege of Pharmacy, Chungnam National University, Daehak-ro 99, Yuseonggu, Daejeon 34134, Korea. jwchae@cnu.ac.kr.ORCID 0000-0001-6026-7063
JaeWoo KimYangji Hospital, 1636 Nambusunhwan-ro, Gwanak-gu, Seoul 08779, Korea. m3116@newyjh.com.
Hwi-Yeol YunCollege of Pharmacy, Chungnam National University, Daehak-ro 99, Yuseonggu, Daejeon 34134, Korea. hyyun@cnu.ac.kr.ORCID 0000-0001-8793-2449

Funding

Chungnam National University N/AKorea Health Industry Development Institute HI17C0927National Research Foundation of Korea 2009-0093815National Research Foundation of Korea 2014R1A1A1006006
6 · The paper itself

Abstract

Traditionally, dosage for pediatric patients has been optimized using simple weight-scaled methods, but these methods do not always meet the requirements of children. To overcome this discrepancy, population pharmacokinetic (PK) modeling of size and maturation functions has been proposed. The main objective of the present study was to evaluate a new modeling method for pediatric patients using clinical data from three different clinical studies. To develop the PK models, a nonlinear mixed effect modeling method was employed, and to explore PK differences in pediatric patients, size with allometric and maturation with Michaelis-Menten type functions were evaluated. Goodness of fit plots, visual predictive check and bootstrap were used for model evaluation. Single application of size scaling to PK parameters was statistically significant for the over one year old group. On the other hand, simultaneous use of size and maturation functions was statistically significant for infants younger than one year old. In conclusion, population PK modeling for pediatric patients was successfully performed using clinical data. Size and maturation functions were applied according to established criteria, and single use of size function was applicable for over one year ages, while size and maturation functions were more effective for PK analysis of neonates and infants.

Indexed as

cyclosporinmaturation functionpediatricspharmacometricsphenobarbitalsize functionvancomycin

Identifiers

PMID31163633
PMCPMC6630378

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Registered trials

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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.