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Confidence Assessment of an Absorption Model Using Limited Solubility and Permeability Data for 21 Drugs within a Dynamic Physiologically-Based Pharmacokinetic Simulator

2015· article· en· W2202100605 on OpenAlexvenueno aff
Stewart C. Wang, Mingxiang Liao, Cindy Q. Xia

Bibliographic record

VenueJournal of Applied Biopharmaceutics and Pharmacokinetics · 2015
Typearticle
Languageen
FieldMedicine
TopicDrug Transport and Resistance Mechanisms
Canadian institutionsnot available
Fundersnot available
KeywordsPharmacokineticsConfidence intervalSolubilityComputer sciencePermeability (electromagnetism)Absorption (acoustics)PharmacologySimulationChemistryMedicineMaterials scienceInternal medicine

Abstract

fetched live from OpenAlex

The objective of this study was to assess the accuracy and precision of the Simcyp ADAM model to predict, from a ‘bottom-up’ approach, the human absorption component within a physiologically-based pharmacokinetic profile. 21 literature compounds with respective in vitro Caco-2 permeability and aqueous solubility limits were inputted in ADAM along with clinical values for volume of distribution and clearance. In this fashion, we directly test the absorption component predicted by ADAM within the PBPK model. Simulated pharmacokinetic parameters (T max , C max and AUC 0-τ ) were compared to clinical parameters. With respect to T max predictions, 58% of the simulations had an error of less than 2-fold. For the compounds with error > 2-fold, 75% were over-predicted. Predictions of C max showed that 48% of the simulations had an error of less than 2-fold. For the compounds with error > 2-fold, the majority (90%) of the C max values were under-predicted. Similar to this, 43% of the AUC 0-τ predictions had an error of less than 2-fold. For the compounds with error > 2-fold, 83% were under-predicted. Taken together, caution must be exercised in the utilization of a ‘bottom-up’ PBPK model approach using limited in vitro permeability data and/or solubility limits to simulate the exposure in human.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Simulation or modeling · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.804
Threshold uncertainty score0.982

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.120
GPT teacher head0.411
Teacher spread0.291 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designSimulation or modeling
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations1
Published2015
Admission routes1
Has abstractyes

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