Evidence map›Paper›PMID 27863168›Full record

ArticleCPT: pharmacometrics & systems pharmacology2016

Integrated Two-Analyte Population Pharmacokinetic Model for Antibody-Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling.

D Lu, L Gibiansky, P Agarwal, R C Dere, C Li, Y-W Chu, J Hirata, A Joshi, J Y Jin, S Girish

Abstract readClinical Trial, Phase I
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
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  4. Review
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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

10 authors.

D LuGenentech Inc, South San Francisco, California, USA.
L GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
P AgarwalGenentech Inc, South San Francisco, California, USA.
R C DereGenentech Inc, South San Francisco, California, USA.
C LiGenentech Inc, South San Francisco, California, USA.
Y-W ChuGenentech Inc, South San Francisco, California, USA.
J HirataGenentech Inc, South San Francisco, California, USA.
A JoshiGenentech Inc, South San Francisco, California, USA.
J Y JinGenentech Inc, South San Francisco, California, USA.
S GirishGenentech Inc, South San Francisco, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An integrated pharmacokinetics (PK) model that simultaneously describes concentrations of total antibody (Tab) and antibody-conjugated monomethyl auristatin E (acMMAE) following administration of monomethyl auristatin E (MMAE)-containing antibody-drug conjugates (ADCs) was developed based on phase I PK data with extensive sampling for two ADCs. Two linear two-compartment models that shared all parameters were used to describe the PK of Tab and acMMAE, except that the deconjugation rate was an additional clearance pathway included in the acMMAE PK model compared to Tab. Further, the model demonstrated its ability to predict Tab concentrations and PK parameters based on observed acMMAE PK and various reduced or eliminated Tab PK sampling schemes of phase II data. Thus, this integrated model allows for the reduction of Tab PK sampling in late-phase clinical development without compromising Tab PK characterization.

Indexed as

Computer SimulationDrug Dosage CalculationsHumansImmunoconjugatesLymphoma, Non-HodgkinModels, BiologicalModels, TheoreticalOligopeptidesPharmaceutical PreparationsImmunoconjugatesmonomethyl auristatin EOligopeptidesPharmaceutical Preparations

Identifiers

PMID27863168
PMCPMC5192970

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.