Evidence map›Paper›PMID 27469324›Full record

ArticlePharmaceutical research2016

Characterization of Pharmacokinetics in the Göttingen Minipig with Reference Human Drugs: An In Vitro and In Vivo Approach.

Floriane Lignet, Eva Sherbetjian, Nicole Kratochwil, Russell Jones, Claudia Suenderhauf, Michael B Otteneder, Thomas Singer, Neil Parrott

Erratum issuedAbstract readComparative Study
PubMed Publisher
In one paragraph

Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.6field-weighted citation impact, top 11% 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.

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, 22 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. AnToxicology reports · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Floriane LignetPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland. floriane.lignet@gmail.com.ORCID 0000-0003-3262-6529
Eva SherbetjianPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Nicole KratochwilPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Russell JonesPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Claudia SuenderhaufKlinische Pharmakologie & Toxikologie, Universitätsspital Basel, Basel, Switzerland.
Michael B OttenederPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Thomas SingerPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Neil ParrottPharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, F. Hoffmann - La Roche, Ltd, Basel, Switzerland.
Roche (Switzerland) · CHUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aims to expand our understanding of the mechanisms of drug absorption, distribution, metabolism and excretion in the Göttingen minipig to aid a knowledge-driven selection of the optimal species for preclinical pharmaceutical research.

methodsThe pharmacokinetics of seven reference compounds (antipyrine, atenolol, cimetidine, diazepam, hydrochlorothiazide, midazolam and theophylline) was investigated after intravenous and oral dosing in minipigs. Supportive in vitro data were generated on hepatocellularity, metabolic clearance in hepatocytes, blood cell and plasma protein binding and metabolism routes.

resultsSystemic plasma clearance for the seven drugs ranged from low (1.1 ml/min/kg, theophylline) to close to liver blood flow (37.4 ml/min/kg, cimetidine). Volume of distribution in minipigs ranged from 0.7 L/kg for antipyrine to 3.2 L/kg for hydrochlorothiazide. A gender-related difference of in vivo metabolic clearance was observed for antipyrine. The hepatocellularity for minipig was determined as 124 Mcells/g liver, similar to the values reported for human. Based on these data a preliminary in vitro to in vivo correlation (IVIVC) for metabolic clearance measured in hepatocytes was investigated. Metabolite profiles of diazepam and midazolam compared well between minipig and human.

conclusionsThe results of the present study support the use of in vitro metabolism data for the evaluation of minipig in preclinical research and safety testing.

Indexed as

Models, AnimalAnimalsFemaleHepatocytesHumansMalePharmaceutical PreparationsProtein BindingSpecies SpecificitySwineSwine, MiniaturePharmaceutical Preparationsin silicometabolismminipigpharmacokinetics

Identifiers

PMID27469324
OpenAlexW2493124445

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.