Evidence map›Paper›PMID 28401479›Full record

SynthesisClinical pharmacokinetics2017

Gestation-Specific Changes in the Anatomy and Physiology of Healthy Pregnant Women: An Extended Repository of Model Parameters for Physiologically Based Pharmacokinetic Modeling in Pregnancy.

André Dallmann, Ibrahim Ince, Michaela Meyer, Stefan Willmann, Thomas Eissing, Georg Hempel

Registry-linked trialAbstract readMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06160583 (General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes), which is not on this map. Cited by 66 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 1 pooled it
7.0field-weighted citation impact, top 2% of its field
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.

NCT06160583 completednot on this mapstarted 2023, after this paper: background citation

General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes

Typeobservational_patient_registrySponsorHospital Civil de GuadalajaraRan2023 to 2024Enrolled5,000ConditionsAnesthesia, Perinatal Morbidity, Maternal-Fetal Relations
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 1 synthesis or guideline pooled it, 110 citations in OpenAlex.

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6 more citing papers are in PubMed but not listed here.

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

6 authors at 2 institutions in 1 country.

André DallmannDepartment of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, Westfälische Wilhelm-University Münster, Münster, Germany.
Ibrahim InceET-TD-ET Systems Pharmacology CV, Bayer AG, Leverkusen, Germany. ibrahim.ince@bayer.com.ORCID 0000-0001-9036-7305
Michaela MeyerDD-CS Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.
Stefan WillmannDD-CS Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.
Thomas EissingET-TD-ET Systems Pharmacology CV, Bayer AG, Leverkusen, Germany.
Georg HempelDepartment of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, Westfälische Wilhelm-University Münster, Münster, Germany.
Bayer (Germany) · DEUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the past years, several repositories for anatomical and physiological parameters required for physiologically based pharmacokinetic modeling in pregnant women have been published. While providing a good basis, some important aspects can be further detailed. For example, they did not account for the variability associated with parameters or were lacking key parameters necessary for developing more detailed mechanistic pregnancy physiologically based pharmacokinetic models, such as the composition of pregnancy-specific tissues.

objectivesThe aim of this meta-analysis was to provide an updated and extended database of anatomical and physiological parameters in healthy pregnant women that also accounts for changes in the variability of a parameter throughout gestation and for the composition of pregnancy-specific tissues.

methodsA systematic literature search was carried out to collect study data on pregnancy-related changes of anatomical and physiological parameters. For each parameter, a set of mathematical functions was fitted to the data and to the standard deviation observed among the data. The best performing functions were selected based on numerical and visual diagnostics as well as based on physiological plausibility.

resultsThe literature search yielded 473 studies, 302 of which met the criteria to be further analyzed and compiled in a database. In total, the database encompassed 7729 data. Although the availability of quantitative data for some parameters remained limited, mathematical functions could be generated for many important parameters. Gaps were filled based on qualitative knowledge and based on physiologically plausible assumptions.

conclusionThe presented results facilitate the integration of pregnancy-dependent changes in anatomy and physiology into mechanistic population physiologically based pharmacokinetic models. Such models can ultimately provide a valuable tool to investigate the pharmacokinetics during pregnancy in silico and support informed decision making regarding optimal dosing regimens in this vulnerable special population.

Indexed as

Databases, FactualHealthModels, BiologicalPharmacokineticsPregnant PeopleFemaleHumansPregnancy

Identifiers

PMID28401479
OpenAlexW2605814101

What Socratic holds

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Read underepoch 390

Registered trials

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.