ReviewAAPS PharmSciTech2018
Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes.
Review in AAPS PharmSciTech, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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
20 citing papers in PubMed.
- Influence of Excipients on the Release Kinetics and Antioxidant Activity of Encapsulated Propolis Phenolic Compounds.Antioxidants (Basel, Switzerland) · 2026Article
- Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified-Release Tablets.CPT: pharmacometrics & systems pharmacology · 2026Article
- A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities.Therapeutic innovation & regulatory science · 2026Article
- Dissolution Profiles Comparison Using Various Model Independent Statistical Approaches: Can We Increase Chance of Similarity?Pharmaceutical research · 2025Article
- A QbD Approach for the Formulation and Control of Triclabendazole in Uncoated Tablets: From Polymorphs to Drug Formulation.Pharmaceutics · 2024Article
- Effects of Glass Bead Size on Dissolution Profiles in Flow-through Dissolution Systems (USP 4).AAPS PharmSciTech · 2024Article
- Quality by Design Perspective for Designing Foam-based Formulation: Current State of Art.Current pharmaceutical design · 2024Review
- Dissolution Profiles Comparison Using Conventional and Bias Corrected and Accelerated f2 Bootstrap Approaches with Different Software's: Impact of Variability, Sample Size and Number of Bootstraps.AAPS PharmSciTech · 2023Article
- Discriminative Dissolution Method Development Through an aQbD Approach.AAPS PharmSciTech · 2023Article
- Article
- Article
- Dietary Supplements with Proline-A Comprehensive Assessment of Their Quality.Life (Basel, Switzerland) · 2023Article
- Application of Liquid Chromatography Coupled to Mass Spectrometry in Quality Assessment of Dietary Supplements-A Case Study of Tryptophan Supplements: Release Assay, Targeted and Untargeted Studies.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Tablet formulation development focusing on the functional behaviour of water uptake and swelling.International journal of pharmaceutics: X · 2021Article
- Investigating In Vitro and Ex Vivo Properties of Artemether/Lumefantrine Double-Fixed Dose Combination Lipid Matrix Tablets Prepared by Hot Fusion.Pharmaceutics · 2021Article
- Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization.The AAPS journal · 2021Article
- Development and Validation of a Discriminatory Dissolution Model for an Immediately Release Dosage Form by DOE and Statistical Approaches.AAPS PharmSciTech · 2021Article
- An In Vitro-In Vivo Simulation Approach for the Prediction of Bioequivalence.Materials (Basel, Switzerland) · 2021Article
- Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets.Scientific reports · 2019Article
- Benefits of Fractal Approaches in Solid Dosage Form Development.Pharmaceutical research · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMAs) and critical product properties (CPPs). The dissolution test has been shown repeatedly to have the power to distinguish between significant changes in active pharmaceutical ingredient (API), formulation, and process that relate to the release mechanism of the in vivo performance. Examples will be discussed in the literature where the effects of formulation, drug substance, and manufacturing variables have been measured by dissolution testing. There will be a suggested plan on how to develop and challenge a discriminating method that may be utilized for regulatory purposes. A brief review of other challenges and considerations regarding discriminatory dissolution testing is presented.
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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.