ReviewJournal of controlled release : official journal of the Controlled Release Society2015
In vitro-in vivo correlation for complex non-oral drug products: Where do we stand?
Review in Journal of controlled release : official journal of the Controlled Release Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 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
43 citing papers in PubMed.
- In Vitro Release Testing for Long Acting Injectables - a Workshop Summary Report.The AAPS journal · 2026Article
- Development of an In Vitro Permeation Test Framework For Naloxone Hydrochloride Intranasal Spray: Establishing IVIVR for Bioequivalence Assessment.Pharmaceutical research · 2026Article
- Diagnosing the Information Limits of In Vitro Drug Release from PLGA Microparticle Data.Pharmaceutics · 2026Article
- Deep-Learning-Enabled SEM Image Segmentation Coupled with Laser Confocal Raman Microscopy: Elucidating Microstructure and Drug Spatial Distribution in Leuprorelin Acetate Microspheres.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Solvent‑Free Bioerodible Ophthalmic Inserts for Mangiferin Delivery: Physicochemical Characterization and In Vivo Evaluation.AAPS PharmSciTech · 2026Article
- A systematic approach to develop and characterize a compositionally equivalent buprenorphine in situ forming implant (Sublocade®).Journal of controlled release : official journal of the Controlled Release Society · 2026Article
- Microstructural Characterization and In Vitro-In Vivo Evaluation of Drug Release and Permeation in Goupi Plaster.Pharmaceutics · 2026Article
- In Vitro Evaluation of Poly(D,L-lactide-co-glycolide) In Situ Gels and Pharmacokinetics Following Subcutaneous Injection in Rats for Model Drugs.Pharmaceutics · 2026Article
- Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes.AAPS PharmSciTech · 2026Review
- The Evolving Role of In Vitro-In Vivo Correlation in Model-Informed Drug Development: A Multi-Stakeholder Perspective.CPT: pharmacometrics & systems pharmacology · 2025Article
- In vitro release method development for Onivyde® using Agilent NanoDis® system.International journal of pharmaceutics · 2025Article
- PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025Review
- Long-acting parenteral formulations of hydrophilic drugs, proteins, and peptide therapeutics: mechanisms, challenges, and therapeutic benefits with a focus on technologies.Drug delivery and translational research · 2025Review
- In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide).Journal of controlled release : official journal of the Controlled Release Society · 2025Review
- Mechanisms and Barriers in Nanomedicine: Progress in the Field and Future Directions.ACS nano · 2024Article
- An Ultrasoft and Flexible PDMS-Based Balloon-Type Implantable Device for Controlled Drug Delivery.Biomaterials research · 2024Article
- Sustained release local anesthetics for pain management: relevance and formulation approaches.Frontiers in pain research (Lausanne, Switzerland) · 2024Review
- Pressure-Spun Fibrous Surgical Sutures for Localized Antibacterial Delivery: Development, Characterization, and In Vitro Evaluation.ACS applied materials & interfaces · 2023Article
- Refining the in vitro release test method for a dapivirine-releasing vaginal ring to match in vivo performance.Drug delivery and translational research · 2023Article
- A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables.Pharmaceutical research · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
In vitro–in vivo correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property and a relevant in vivo response of drug products. Since the U.S. Food and Drug Administration (FDA) published a regulatory guidance on the development, evaluation, and applications of IVIVC for extended release (ER) oral dosage forms in 1997, IVIVC has been one of the most important issues in the field of pharmaceutics. However, even with the aid of the FDA IVIVC Guidance, only very limited Abbreviated New Drug Application (ANDA) submission for ER oral drug products included adequate IVIVC data to enable the completion of bioequivalence (BE) review within first review cycle. Establishing an IVIVC for non-oral dosage forms has remained extremely challenging due to their complex nature and the lack of in vitro release methods that are capable of mimicking in vivo drug release conditions. This review presents a general overview of recent advances in the development of IVIVC for complex non-oral dosage forms (such as parenteral polymeric microspheres/implants, and transdermal formulations), and briefly summarizes the knowledge gained over the past two decades. Lastly this review discusses possible directions for future development of IVIVC for complex non-oral dosage forms.
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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.