ArticleAAPS PharmSciTech2023
Discriminative Dissolution Method Development Through an aQbD Approach.
Article in AAPS PharmSciTech, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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Who cites it
5 citing papers in PubMed.
- Navigating Surfactant Selection in In Vitro Dissolution Testing: Mechanistic Insights and Practical Strategies.AAPS PharmSciTech · 2026Review
- 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
- Scientific and Regulatory Standards for Dissolution Similarity: a Statistical Game of Matchmaking Neither Force to Pass or Nor Fail to Pass.AAPS PharmSciTech · 2026Review
- Nanocrystals as a promising approach for enhancing solubility and dissolution of etoricoxib using Box-Behnken design.Scientific reports · 2025Article
- Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release.The AAPS journal · 2025Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Using a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method-related parameters. In the second stage, we established a Formulation-Discrimination Correlation Diagram strategy to examine the method discrimination capability, through which one can determine the method discriminative design region (MDDR) and visualize the impact of each formulation parameter and their interactions on dissolution. The application of aQbD principles into a workflow provides a scientific-driven guidance for robust method development and demonstrating discrimination power for dissolution methods.
Indexed as
Identifiers
38066324What 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.