Evidence map›Paper›PMID 40790008›Full record

ArticleThe AAPS journal2025

Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products.

Ping Ji, William M Boyd, Chandrahas Sahajwalla

Abstract read
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In one paragraph

Article in The AAPS journal, 2025. 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

3 authors.

Ping JiDivision of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, United States of America. Ping.ji@fda.hhs.gov.ORCID 0000-0002-4821-9509
William M BoydDivision of Ophthalmology, Office of Specialty Medicine, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, United States of America.
Chandrahas SahajwallaDivision of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A clinical development program for follow-on locally acting intravitreal drug products typically includes a comparative efficacy study. Pharmacokinetic assessment is often considered of limited value because systemic exposure is low and/or not predictive of efficacy at the site of action. In this commentary, we evaluated the relevance of pharmacokinetics for locally acting intravitreal large molecule drug products. Our assessment showed that systemic pharmacokinetic information including the rate constant could provide valuable insights into estimating local exposure of intravitreally administered drugs. This information has the potential to introduce a novel approach to clinical development programs for follow-on locally acting intravitreal drug products.

Indexed as

Drug DevelopmentHumansIntravitreal Injectionsintravitreal dosinglocally actingpharmacokinetic bridging

Identifiers

PMID40790008

What OpenQuestion holds

Textmetadata
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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.