ReviewThe AAPS journal2022
Evaluation of Excipient Risk in BCS Class I and III Biowaivers.
Review in The AAPS journal, 2022. 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.
- Breaking the Solubility-Permeability Tradeoff: Surfactant-Mediated Enhancement of Oral Etoposide Absorption.Biomolecules · 2026Article
- Biopharmaceutical Characterization of Grapiprant Within the BCS Framework Under Canine-Relevant Conditions: Solubility and Caco-2 Permeability Assessment.Pharmaceutics · 2026Article
- Bioequivalence Evaluation of Immediate-Release Empagliflozin/Metformin Fixed-Dose Combination Tablets Under Fed Conditions in Healthy Mexican Subjects and Exploratory Analysis of Metformin Dose Proportionality.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Bioequivalence of a Generic Vortioxetine 20 mg Tablet in Healthy Mexican Volunteers Under Fasting Conditions.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Elucidating the Critical Role of Excipients in Gastric Emptying and Oral Absorption of a Rapidly Eliminated BCS I Drug: Implications from Zidovudine Bioequivalence.Pharmaceutics · 2026Article
- Development and Evaluation of Tofacitinib Tablets with Comparative Dissolution and Pharmacokinetic Studies in Beagle Dogs.AAPS PharmSciTech · 2026Article
- Reduced-Resistances Model for Enhanced Drug Permeation via a Solubilizing Receiver Medium: A Mechanistic Study with Hollow Fiber Membranes.Molecular pharmaceutics · 2026Article
- Recent Advances in Oral Drug Delivery Systems for BCS III Drugs.Current issues in molecular biology · 2026Review
- Microbiome-aware oral drug delivery: excipient-microbiome interactions and nanocarrier design rules for predictable formulation performance.Frontiers in pharmacology · 2026Review
- Exploring Experimental and Statistical Approaches to Control Oversensitivity of In Vitro Permeability to Excipient Effects.Pharmaceutics · 2025Article
- Nanoemulsion Technology in Oral Drug Delivery: A Path to Enhanced Solubility and Bioavailability.Current pharmaceutical design · 2025Review
- New Horizons in Antiretroviral Drug Delivery Systems for HIV Management.Current medicinal chemistry · 2025Review
- Biowaiver based on biopharmaceutics classification system: Considerations and requirements.Pharmaceutical science advances · 2024Review
- Decreased Penetration Mechanism of Ranitidine Due to Application of Sodium Sulfobutyl Ether-β-Cyclodextrin.Pharmaceutics · 2023Article
- Adapting physiologically-based pharmacokinetic models for machine learning applications.Scientific reports · 2023Article
- The Rat Continuous Intestine Model Predicts the Impact of Particle Size and Transporters on the Oral Absorption of Glyburide.Molecular pharmaceutics · 2023Article
- Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals.Pharmaceuticals (Basel, Switzerland) · 2022Review
- A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption.The AAPS journal · 2022Review
- A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development.The AAPS journal · 2022Review
- State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References.The AAPS journal · 2022Review
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
No grant is acknowledged in the PubMed record.
Abstract
The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here. Graphical Abstract.
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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.