Evidence map›Paper›PMID 39542257›Full record

ReviewJournal of controlled release : official journal of the Controlled Release Society2025

In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide).

Yan Wang, Andrew Otte, Haesun Park, Kinam Park

Abstract readReview
In one paragraph

Review in Journal of controlled release : official journal of the Controlled Release Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. How PLGA Microspheres are Emerging as a Key Drug Delivery System.International journal of nanomedicine · 2026
    Review
  10. Materials today. Bio · 2025
    Review
  11. PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Review
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

4 authors.

Yan WangFood and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, Silver Spring, MD 20993, USA.
Andrew OttePurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA.
Haesun ParkAkina, Inc, West Lafayette, IN 47906, USA.
Kinam ParkPurdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA; Purdue University, Department of Industrial and Molecular Pharmaceutics, West Lafayette, IN 47907, USA. Electronic address: kpark@purdue.edu.

Funding

Injectable naltrexone 2-month depot formulationsUH3DA048774 · NIDA · PURDUE UNIVERSITY · PI PARK, KINAM · 2022 to 2024
$4.9M
Injectable naltrexone 2-month depot formulationsUG3DA048774 · NIDA · PURDUE UNIVERSITY · PI PARK, KINAM · 2019 to 2020
$2.9M
NIDA NIH HHS UG3 DA048774NIDA NIH HHS UH3 DA048774
6 · The paper itself

Abstract

In vitro-in vivo correlation (IVIVC), linking in vitro drug release to in vivo drug release or in vivo drug absorption, has been explored chiefly for oral extended-release dosage forms. Currently, there are no official guidelines on IVIVC development for non-oral drug delivery systems. Recently, many long-acting injectable (LAI) formulations based on poly(lactide-co-glycolide) (PLGA) have been developed to deliver various drugs, ranging from small molecules to peptides and proteins, for up to 6 months. The circumstances involved in the LAI formulations are drastically different from those in oral formulations, which generally deliver drugs for a maximum of 24 h. This article examines 37 IVIVC studies of PLGA microparticle formulations available in the literature. Understanding and establishing an IVIVC of LAI formulations requires more than merely plotting the percentage in vitro drug release against the percentage in vivo absorption. In vivo drug absorption (or release) should be measured to provide a complete pharmacokinetic profile when feasible. Accelerated in vitro release methods need to be respective of the real-time measurements by sharing the same release mechanism. Obtaining meaningful IVIVCs with predictive capability will be highly useful for future regulatory actions and for developing generic and new formulations.

Indexed as

Delayed-Action PreparationsDrug LiberationPolylactic Acid-Polyglycolic Acid CopolymerAnimalsDrug Delivery SystemsDrug DevelopmentHumansInjectionsDelayed-Action PreparationsPolylactic Acid-Polyglycolic Acid CopolymerDrug release mediumInjectable long-acting microparticlesIn vitro drug release testingIVIVCPLGA

Identifiers

PMID39542257
PMCPMC11663134

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.