Evidence map›Paper›PMID 37848754›Full record

ReviewThe AAPS journal2023

Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development.

Maxime Siemons, Bram Schroyen, Nicolas Darville, Navin Goyal

Abstract readReview
PubMed Publisher
In one paragraph

Review 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Lenacapavir: Playing the Long Game in the New Era of Antiretrovirals.Clinical pharmacology and therapeutics · 2025
    Review
  6. Article
  7. 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

4 authors.

Maxime SiemonsJanssen R&D, Johnson & Johnson, Turnhoutseweg 30, Beerse, Belgium. msiemon1@its.jnj.com.
Bram SchroyenJanssen R&D, Johnson & Johnson, Turnhoutseweg 30, Beerse, Belgium.
Nicolas DarvilleJanssen R&D, Johnson & Johnson, Turnhoutseweg 30, Beerse, Belgium.
Navin GoyalJanssen R&D, Johnson & Johnson, Turnhoutseweg 30, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Innovations in the field of long-acting injectable drug development are increasingly being reported. More advanced in vitro and in vivo characterization can improve our understanding of the injection space and aid in describing the long-acting injectable (LAI) drug's behavior at the injection site more mechanistically. These innovations may enable unlocking the potential of employing a model-based framework in the LAI preclinical and clinical space. This review provides a brief overview of the LAI development process before delving deeper into the current status of modeling and simulation approaches in characterizing the preclinical and clinical LAI pharmacokinetics, focused on aqueous crystalline suspensions. A closer look is provided on in vitro release methods, available biopharmaceutical models and reported in vitro/in vivo correlations (IVIVCs) that may advance LAI drug development. The overview allows identifying the opportunities for use of model-informed drug development approaches and potential gaps where further research may be most warranted. Continued investment in improving our understanding of LAI PK across species through translational approaches may facilitate the future development of LAI drug products.

Indexed as

Antipsychotic AgentsSchizophreniaDelayed-Action PreparationsHumansInjectionsSuspensionsAntipsychotic AgentsDelayed-Action PreparationsSuspensionsin vitro–in vivo correlationlong-acting injectablesmodel-informed drug development (MIDD)physiologically based pharmacokinetic modelingpreclinical translation

Identifiers

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.