Evidence map›Paper›PMID 30443681›Full record

ArticlePharmaceutical research2018

Bioequivalence Study Methods with Pharmacokinetic Endpoints for Topical Ophthalmic Corticosteroid Suspensions and Effects of Subject Demographics.

Yoriko Harigaya, Xiaojian Jiang, Hongling Zhang, Parthapratim Chandaroy, Ethan M Stier, Yuzhuo Pan

Abstract read
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Article in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
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

3 citing papers in PubMed, 12 citations in OpenAlex.

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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 at 2 institutions in 1 country.

Yoriko HarigayaDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA. Yoriko.Harigaya@fda.hhs.gov.
Xiaojian JiangDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Hongling ZhangDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Parthapratim ChandaroyDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Ethan M StierDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Yuzhuo PanDivision of Bioequivalence II, Office of Bioequivalence, Office of Generic Drug, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
United States Food and Drug Administration · USCenter for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo establish bioequivalence for topical ophthalmic corticosteroid suspensions, some of U.S. product-specific guidances (PSGs) for generic drug products recommend evaluation of aqueous humor (AH) pharmacokinetics (PK). However, the AH PK study is complex because the relationships among AH PK, subject demographics, ocular anatomy, physiology and the compounds' physicochemical characteristics are not well understood. The objective of this research is to provide an overview of the in vivo human AH studies submitted to the U.S. Food and Drug Administration (FDA) for ophthalmic corticosteroid suspensions and to investigate the impact of subject demographics on the human AH PK.

methodsWe summarized demographic data, sampling time points, sample size per time point and PK parameters to investigate correlations in the studies submitted to the FDA.

resultsIn the evaluation of subject-specific covariates, the area under the concentration-time curves (AUC) and maximum concentrations (C

conclusionsOur results suggest that the difference in ethnicity and age of the study population play an important role in the AH PK profiles of topical ophthalmic corticosteroid suspensions. Considering the subject-specific covariate effects in designing bioequivalence studies with AH PK endpoints could reduce bias from covariate imbalance and help identify true effects of formulation differences.

Indexed as

Administration, OphthalmicAdrenal Cortex HormonesAdultAgedAged, 80 and overAge FactorsAqueous HumorDemographyEthnicityEyeFemaleHumansMaleMiddle AgedSex FactorsSuspensionsAdrenal Cortex HormonesSuspensionsAqueous humorbioequivalenceocular pharmacokineticsophthalmic corticosteroid suspensionssubject demographics

Identifiers

PMID30443681
OpenAlexW2901953387

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.