Evidence map›Paper›PMID 42399602›Full record

ReviewPharmaceutical medicine2026

Regulatory Considerations for Combined Drug-Device Studies in Europe: A Case Study Involving Bile Sampling.

Hans-Peter Podhaisky, Emiko Tsuruta, Isabel Piel, Christiane Otto, Sofia Busto Paez, Miriam Font-Nieves

Abstract readReview
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In one paragraph

Review in Pharmaceutical medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Hans-Peter PodhaiskyBayer AG, Pharmaceuticals R&D, Müllerstr. 178, 13353, Berlin, Germany. hans-peter.podhaisky@bayer.com.ORCID http://orcid.org/0000-0003-3414-9252
Emiko TsurutaBayer AG, Pharmaceuticals R&D, Wuppertal, Germany.
Isabel PielBayer AG, Pharmaceuticals R&D, Wuppertal, Germany.ORCID http://orcid.org/0000-0002-6745-3069
Christiane OttoBayer AG, Pharmaceuticals R&D, Wuppertal, Germany.ORCID http://orcid.org/0000-0002-6037-4616
Sofia Busto PaezBayer AG, Pharmaceuticals R&D, Müllerstr. 178, 13353, Berlin, Germany.
Miriam Font-NievesBayer Hispania, S.L.U., Regulatory Affairs, Sant Joan Despi, Spain.ORCID http://orcid.org/0009-0001-8423-6189

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Identifiers

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.