ReviewPharmaceutics2021
The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence.
Review in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- Development and Study of Hydrophilic Ointment Compositions with a Dextrin/Polyvinyl Alcohol/Iodine Complex (D/PVA/I).Pharmaceuticals (Basel, Switzerland) · 2026Article
- Engineering a Nanostructured Hybrid Gel System with Sodium Humate for Enhanced Wound Healing.Journal of functional biomaterials · 2026Article
- The Impact of Using Measured In Vitro Data to Develop Physiologically Based Pharmacokinetic Models of Dermal Absorption: An IVIVE Case Study.The AAPS journal · 2025Article
- Enhancing Transcutaneous Drug Delivery: Advanced Perspectives on Skin Models.JID innovations : skin science from molecules to population health · 2025Review
- Evaluation of Physicochemical, Microstructure Parameters (Q3) and Performance Attributes of Commercial Ketoprofen Gels.AAPS PharmSciTech · 2025Article
- Recent Advances in the Preparation, Properties, and Applications of Solid Lipid Nanoparticles in Drug Delivery.Pharmaceutical nanotechnology · 2025Review
- Update on the advances and challenges in bioequivalence testing methods for complex topical generic products.Frontiers in pharmacology · 2024Review
- Bigel Formulations of Nanoencapsulated St. John's Wort Extract-An Approach for Enhanced Wound Healing.Gels (Basel, Switzerland) · 2023Article
- Gel Formulations with an Echinocandin for Cutaneous Candidiasis: The Influence of Azone and Transcutol on Biopharmaceutical Features.Gels (Basel, Switzerland) · 2023Article
- Antimicrobial Resistance and Recent Alternatives to Antibiotics for the Control of Bacterial Pathogens with an Emphasis on Foodborne Pathogens.Antibiotics (Basel, Switzerland) · 2023Review
- Does the Freeze-Thaw Technique Affect the Properties of the Alginate/Chitosan Glutamate Gels with Posaconazole as a Model Antifungal Drug?International journal of molecular sciences · 2022Article
- Novel Hydrogels for Topical Applications: An Updated Comprehensive Review Based on Source.Gels (Basel, Switzerland) · 2022Review
- Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation.Pharmaceutics · 2021Article
- Impact of Alkanediols on Stratum Corneum Lipids and Triamcinolone Acetonide Skin Penetration.Pharmaceutics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Due to complex interdependent relationships affecting their microstructure, topical semisolid drug formulations face unique obstacles to the development of generics compared to other drug products. Traditionally, establishing bioequivalence is based on comparative clinical trials, which are expensive and often associated with high degrees of variability and low sensitivity in detecting formulation differences. To address this issue, leading regulatory agencies have aimed to advance guidelines relevant to topical generics, ultimately accepting different non-clinical, in vitro/in vivo surrogate methods for topical bioequivalence assessment. Unfortunately, according to both industry and academia stakeholders, these efforts are far from flawless, and often upsurge the potential for result variability and a number of other failure modes. This paper offers a comprehensive review of the literature focused on amending regulatory positions concerning the demonstration of (i) extended pharmaceutical equivalence and (ii) equivalence with respect to the efficacy of topical semisolids. The proposed corrective measures are disclosed and critically discussed, as they span from mere demands to widen the acceptance range (e.g., from ±10% to ±20%/±25% for rheology and in vitro release parameters highly prone to batch-to-batch variability) or reassess the optimal number of samples required to reach the desired statistical power, but also rely on specific data modeling or novel statistical approaches.
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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.