Evidence map›Paper›PMID 34241561›Full record

ArticlemAbs

Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting.

Thomas Kissner, Guenter Blaich, Andreas Baumann, Sven Kronenberg, Adam Hey, Andrea Kiessling, Petra M Schmitt, Wouter Driessen, Chantal Carrez, Daniel Kramer and 5 more

Abstract readConference Proceedings
In one paragraph

Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
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

15 authors.

Thomas KissnerPreclinical Safety, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Guenter BlaichPreclinical Safety, AbbVie Deutschland GmbH, Ludwigshafen, Germany.
Andreas BaumannR&D Pharmaceuticals, Translational Sciences, Bayer AG, Berlin, Germany.
Sven KronenbergPharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Adam HeyOncology Safety, Clinical Pharmacology and Safety Sciences, AstraZeneca, Cambridge, UK.
Andrea KiesslingPreclinical Safety, Novartis Pharma, Basel, Switzerland.
Petra M SchmittPreclinical Safety, AbbVie Deutschland GmbH, Ludwigshafen, Germany.
Wouter DriessenPharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Chantal CarrezSanofi R&D, Translational In Vivo Models, Sanofi S.A, Vitry-sur-Seine, France.
Daniel KramerSanofi R&D, Translational Medicine & Early Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Jennifer FretlandDrug Metabolism and Pharmacokinetics, Sanofi US, Waltham, MA, USA.
Wolfgang F RichterPharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Tobias PaehlerDrug Metabolism and Pharmacokinetics, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
Ulrike HopferPharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Benno RattelTranslational Safety & Bioanalytical Sciences, Amgen Research (Munich) GmbH, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

New challenges and other topics in non-clinical safety testing of biotherapeutics were presented and discussed at the nineth European BioSafe Annual General Membership meeting in November 2019. The session topics were selected by European BioSafe organization committee members based on recent company achievements, agency interactions and new data obtained in the non-clinical safety testing of biotherapeutics, for which data sharing would be of interest and considered as valuable information. The presented session topics ranged from strategies of

Indexed as

Drug Evaluation, PreclinicalHumansBiologicsimagingimmunogenicitymAbnon-clinical safetypharmacokinetics

Identifiers

PMID34241561
PMCPMC8274438

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.