Evidence map›Paper›PMID 38675213›Full record

ArticlePharmaceutics2024

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables.

Daniela Amaral Silva, Maxime Le Merdy, Khondoker Dedarul Alam, Yan Wang, Quanying Bao, Nilesh Malavia, Diane Burgess, Viera Lukacova

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

8 authors.

Daniela Amaral SilvaSimulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA.
Maxime Le MerdySimulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA.ORCID 0000-0003-2629-8039
Khondoker Dedarul AlamDivision of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Yan WangDivision of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Quanying BaoDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.ORCID 0000-0002-1194-5777
Nilesh MalaviaDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.
Diane BurgessDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.ORCID 0000-0002-6471-2109
Viera LukacovaSimulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA.

Funding

United States Food and Drug Administration 75F40121C00133
6 · The paper itself

Abstract

Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory assessment of LAI drug products due to a limited understanding of the tissue response to injected particles (e.g., inflammation) impacting in vivo performance. Mechanism-based in silico methods may support the understanding of LAI-physiology interactions. The objectives of this study were as follows: (1) to use a mechanistic modeling approach to delineate the in vivo performance of DepoSubQ Provera

Indexed as

complex genericslong-acting injectable suspensionsmedroxyprogesterone acetatePBBKPBBM

Identifiers

PMID38675213
PMCPMC11054330

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.