Evidence map›Paper›PMID 39311714›Full record

ArticleMolecular pharmaceutics2024

Advancing the Harmonization of Biopredictive Methodologies through the Product Quality Research Institute (PQRI) Consortium: Biopredictive Dissolution of Dipyridamole Tablets.

Yasuhiro Tsume, Lee Ashworth, Marival Bermejo Sanz, Vincent Cicale, Jennifer Dressman, Masahiro Fushimi, Isabel Gonzalez-Alvarez, Pin-Syuan Haung, Corinne Jankovsky, Xiaohong Liu and 7 more

Abstract read
In one paragraph

Article in Molecular pharmaceutics, 2024. 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

17 authors.

Yasuhiro TsumeMerck & Co., Inc., Rahway, New Jersey 07065, United States.ORCID 0009-0005-1374-314X
Lee AshworthAstraZeneca, Macclesfield, Cheshire SK10 4TF, United Kingdom.
Marival Bermejo SanzMiguel Hernandez University, Alicante 03550, Spain.
Vincent CicaleBristol-Myers Squibb Company, New Brunswick, New Jersey 08901, United States.
Jennifer DressmanFraunhofer Institute for Translational Medicine Pharmacology, Frankfurt 60596, Germany.
Masahiro FushimiSawai Pharmaceutical Co. Ltd., Osaka 532-0003, Japan.
Isabel Gonzalez-AlvarezMiguel Hernandez University, Alicante 03550, Spain.ORCID 0000-0002-1685-142X
Pin-Syuan HaungUniversity of Minnesota, Minneapolis, Minnesota 55455, United States.
Corinne JankovskyBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 05877, United States.
Xiaohong LiuUniversity of Minnesota, Minneapolis, Minnesota 55455, United States.
Xujin LuBristol-Myers Squibb Company, New Brunswick, New Jersey 08901, United States.
Kazuki MatsuiSawai Pharmaceutical Co. Ltd., Osaka 532-0003, Japan.
Sanjaykumar PatelMerck & Co., Inc., Rahway, New Jersey 07065, United States.
Alejandro Ruiz-PicazoMiguel Hernandez University, Alicante 03550, Spain.
Changquan Calvin SunUniversity of Minnesota, Minneapolis, Minnesota 55455, United States.ORCID 0000-0001-7284-5334
Naveen ThakralSchrodinger Inc., New York, New York 10036, United States.
Laurin ZöllerFraunhofer Institute for Translational Medicine Pharmacology, Frankfurt 60596, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biorelevant dissolution and its concept have been widely accepted and further developed to meaningfully predict the bioperformance of oral drug products. Biorelevant methodologies have been applied to design and optimize oral formulations, to facilitate formulation bridging, and to predict the outcome of bioperformance by coupling the results with modeling. Yet, those methodologies have often been independently customized to align with specific aspects of the oral drug products being developed. Therefore, the evolution of biorelevant dissolution methodologies has taken slightly diverse pathways rather than being standardized like compendial quality control (QC) methodologies. This manuscript presents an effort through the Product Quality Research Institute (PQRI, https://pqri.org) consortium entitled: the standardization of "

Indexed as

DipyridamoleQuality ControlSolubilityTabletsAdministration, OralChemistry, PharmaceuticalDrug CompoundingDrug LiberationHumansTherapeutic EquivalencyDipyridamoleTabletsbiorelevant dissolutionin vivo predictive dissolutionmethod harmonizationmodelingphysiologically based biopharmaceutics modeling (PBBM)

Identifiers

PMID39311714
PMCPMC11468891

What OpenQuestion holds

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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.