Evidence map›Paper›PMID 41420546›Full record

ArticleBiopharmaceutics & drug disposition2025

Development of a Physiologically Based Pharmacokinetic (PBPK) Simulation Model for Nicotine.

Brian Kim, Sung Hun Bae, Mohamed Bashar, Bofang Yi, Mohammad Asikur Rahman, Prince Awuah, Matthew Hartog, Rony Panarsky, Tao Zhang

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Biopharmaceutics & drug disposition, 2025. 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

9 authors.

Brian KimSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.
Sung Hun BaeSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.
Mohamed BasharSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.
Bofang YiSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.
Mohammad Asikur RahmanSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.
Prince AwuahCenter for Tobacco Products, Division of Nonclinical Science, Office of Science, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Matthew HartogCenter for Tobacco Products, Division of Nonclinical Science, Office of Science, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Rony PanarskyCenter for Tobacco Products, Division of Nonclinical Science, Office of Science, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Tao ZhangSchool of Pharmacy and Pharmaceutical Sciences, Binghamton University, State University of New York, Binghamton, New York, USA.ORCID https://orcid.org/0000-0002-9268-8230

Funding

FDA HHS 75F40122C00146Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Tobacco is a major cause of chronic diseases such as lung cancer, cardiovascular disease, and chronic obstructive pulmonary disease worldwide. Nicotine, the primary psychoactive component in tobacco, is highly addictive and while not the primary driver of such tobacco-related diseases, poses various health risks, particularly those affecting the cardiovascular and pulmonary systems. Although nicotine-based therapies, such as nicotine replacement products, are widely utilized in smoking cessation efforts today, the impact of newer, tobacco delivery systems such as electronic nicotine delivery systems, or ENDS, remains uncertain and warrants continued evaluation. This study aims to develop and validate a physiologically based pharmacokinetic (PBPK) simulation model for nicotine using clinical pharmacokinetic data. The PBPK simulation model for nicotine was developed by incorporating drug-specific and system-specific parameters and by considering the systemic absorption, distribution, metabolism, and excretion of nicotine as well as its overall pharmacokinetic behavior on GastroPlus version 9.9. Validation of the developed PBPK model was performed by comparing predicted and observed plasma concentration-time profiles and pharmacokinetic parameters from clinical studies across multiple routes of administration including intravenous infusion, bolus, and pulmonary inhalation. The resulting model accurately captured plasma nicotine concentrations, with predicted pharmacokinetic parameters (C

Indexed as

Models, BiologicalNicotineNicotinic AgonistsAdministration, InhalationAdultComputer SimulationFemaleHumansMaleMiddle AgedTobacco Use Cessation DevicesNicotineNicotinic AgonistsGastroPlusnicotinepbpk simulationpharmacokinetics

Identifiers

PMID41420546
PMCPMC12757703

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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.