ReviewThe AAPS journal2021
FDA's Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes.
Review in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers.
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.
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.
Who cites it
69 citing papers in PubMed, 162 citations in OpenAlex.
- Generic Long-Acting Injectable Product Availability and Approval Standards.Pharmaceutical research · 2026Article
- Article
- Review
- An Overview of In Vitro Release Methods for Long-Acting Injectable Products Based on PLGA.Methods and protocols · 2026Review
- PLGA nanoparticles encapsulating fibroblast growth factor 21 alleviate acetaminophen-induced acute liver injury.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Engineered cargo-free nanoparticle decoys for phagocytic modulation of macrophages.Journal of controlled release : official journal of the Controlled Release Society · 2026Article
- A hybrid polymeric system for pulmonary mRNA delivery: Advancing mucosal vaccine development.Cell biomaterials · 2026Article
- Advancing Rare Cancer Therapeutics: Osimertinib-Loaded Inhaled PLGA Nanoparticles for Mesothelioma Treatment.AAPS PharmSciTech · 2026Article
- Small vesicles, big potential: A review of innovative exosome delivery and molecular mechanisms in preclinical myocardial infarction models.Animal models and experimental medicine · 2026Review
- Repeated pulmonary dosing of β-glucan-chitosan-PLGA nanoparticles controlsAntimicrobial agents and chemotherapy · 2026Article
- Classification system proposed to guide the design, development, regulatory approval, and scaling of long acting, small- and macro-molecule parenteral products (CS-BLAP).Journal of pharmaceutical sciences · 2026Review
- Preparation and in vitro sustained release performance of thermosensitive gel microsphere composite loaded with Anti-Tuberculosis drug PaMZ/BMP-2.Journal of orthopaedic surgery and research · 2026Article
- A tissue-engineered human psoriatic skin model: targeting inflammation and glucose metabolism dysregulation in psoriasis using microneedle patches.Frontiers in molecular biosciences · 2026Article
- Comparison of In-Vitro and In-Vivo Drug Release of Dexamethasone/PLGA Intravitreal Implants Using Two In-Vitro Release Methods and a Rabbit Model.Molecular pharmaceutics · 2025Article
- Ketorolac, melatonin and latanoprost tri-loaded PLGA microspheres for neuroprotection in glaucoma.Drug delivery · 2025Article
- Extended osteoarthritis pain relief with neosaxitoxin using alginate-core polymeric microparticles.Nanoscale · 2025Article
- Toward Long-Acting Psoriasis Therapy with Phloretin-Loaded Microneedle Patches: Insights fromACS pharmacology & translational science · 2025Article
- Novel Nanomaterials for Developing Bone Scaffolds and Tissue Regeneration.Nanomaterials (Basel, Switzerland) · 2025Review
- PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025Review
- Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Poly (lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations which have been approved by the US Food and Drug Administration (FDA). However, generic counterparts for PLGA products have yet to gain FDA approval due to many complexities in formulation, characterization, and evaluation of test products. To address the challenges of generic development of PLGA-based products, the FDA has established an extensive research program to investigate novel methods and tools to aid both product development and regulatory review. The research focus have been: (1) analytical tools for characterization of PLGA polymers; (2) impacts of PLGA characteristics and manufacturing conditions on product performance; (3) in vitro drug release testing and in vitro-in vivo correlation of PLGA-based products, and (4) modeling tools to facilitate formulation design and bioequivalence study design of PLGA-based drugs. This article provides an overview of FDA's PLGA research program and highlights scientific accomplishments as well as regulatory outcomes that have resulted from successful research investigations.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.