Evidence map›Paper›PMID 37936002›Full record

ArticleThe AAPS journal2023

Drug Dissolution in Oral Drug Absorption: Workshop Report.

Kimberly Raines, Payal Agarwal, Patrick Augustijns, Alaadin Alayoubi, Lucas Attia, Annette Bauer-Brandl, Martin Brandl, Parnali Chatterjee, Hansong Chen, Yuly Chiang Yu and 36 more

Abstract read
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In one paragraph

Article in The AAPS journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
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

46 authors.

Kimberly RainesFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Payal AgarwalFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Patrick AugustijnsDepartment of Pharmaceutical and Pharmacological Sciences, University of Leuven, ON2 Herestraat 49-Box 921, 3000, Leuven, Belgium.
Alaadin AlayoubiFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Lucas AttiaMassachusetts Institute of Technology, 77 Massachusetts Ave, Cambridge, Massachusetts, 02139, USA.
Annette Bauer-BrandlUniversity of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
Martin BrandlUniversity of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
Parnali ChatterjeeFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Hansong ChenFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Yuly Chiang YuUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Carrie CoutantEli Lilly and Company, 893 Delaware St, Indianapolis, Indiana, 46225, USA.
Ana Luisa CoutinhoUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
David CurranGlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, Pennsylvania, 19046, USA.
Jennifer DressmanFraunhofer Institute of Translational Pharmacology and Medicine, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Bryan EricksenFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Leah FaladeFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Yi GaoAbbVie Inc, 1 North Waukegan Road, North Chicago, Illinois, 60064, USA.
Zongming GaoFood and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri, USA.
Debasis GhoshFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Tapash GhoshFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Anitha GovadaFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Elizabeth GrayFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Ruiqiong GuoTakeda Pharmaceuticals, 650 E Kendall St, Cambridge, Massachusetts, 02142, USA.
Dana HammellUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Andre HermansMerck & Co. Inc., 2025 E Scott Ave, Rahway, New Jersey, 07065, USA.
Rohit JainiPfizer Inc., 1 Portland St, Cambridge, Massachusetts, 02139, USA.
Hanlin LiVertex Pharmaceuticals, 50 Northern Ave, Boston, Massachusetts, 02210, USA.
Haritha MandulaFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Shuaiqian MenUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Johanna MilsmannBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88400, Biberach an der Riss, Germany.
Huong MoldthanFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Rebecca MoodyFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Dana E MosesonPfizer Inc., 558 Eastern Point Rd., Groton, Connecticut, 06340, USA.
Anette MüllertzUniversity of Copenhagen, Nørregade 10, 1165, København, Denmark.
Roshni PatelUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Kalpana PaudelFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Christos ReppasNational and Kapodistrian University of Athens, 157 72, Athens, Greece.
Rajesh SavkurFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Kerstin SchaeferBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88400, Biberach an der Riss, Germany.
Abu SerajuddinDepartment of Pharmaceutical Sciences, St John's University, 8000 Utopia Parkway, Queens, New York, USA.
Lynne S TaylorPurdue University, 610 Purdue Mall, West Lafayette, Indiana, 47907, USA.
Rutu ValapilUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Kevin WeiFood and Drug Administration, Center for Drug Evaluation and Research, White Oak, Maryland, USA.
Werner WeitschiesUniversity of Greifswald, Domstraβe 11, 17489, Greifswald, Germany.
Shinji YamashitaRitsumeikan University, 56-1 Tojiin Kitamachi, Kita Ward, Kyoto, 603-8577, Japan.
James E PolliUniversity of Maryland School of Pharmacy, Baltimore, Maryland, USA. jpolli@rx.umaryland.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The in-person workshop "Drug Dissolution in Oral Drug Absorption" was held on May 23-24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics that repeatedly surfaced across breakout sessions were the following: (1) meaning and assessment of "dissolved drug," particularly of poorly water soluble drug in colloidal environments (e.g., fed conditions, ASDs); (2) potential limitations of a test that employs sink conditions for a poorly water soluble drug; (3) non-compendial methods (e.g., two-stage or multi-stage method, dissolution/permeation methods); (4) non-compendial conditions (e.g., apex vessels, non-sink conditions); and (5) potential benefit of having both a quality control method for batch release and a biopredictive/biorelevant method for biowaiver or bridging scenarios. An identified obstacle to non-compendial methods is the uncertainty of global regulatory acceptance of such methods.

Indexed as

BiopharmaceuticsIntestinal AbsorptionDrug LiberationHumansSolubilityWaterWaterabsorptionamorphousdissolutionfoodpermeabilitysolubility

Identifiers

PMID37936002

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.