ReviewThe AAPS journal2009
In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases.
Review in The AAPS journal, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 34 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
34 citing papers in PubMed, 81 citations in OpenAlex.
- The Application of Machine Learning in the Development of Co-Amorphous Dry Powder Inhalation.AAPS PharmSciTech · 2026Article
- Pulmonary Drug Delivery for Infectious Diseases: Cutting-Edge Formulations and Manufacturing Technologies.Pharmaceutics · 2026Review
- Optimization of Carrier-Based Dry Powder Inhaler Performance: A Review.Pharmaceutics · 2025Review
- Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.CPT: pharmacometrics & systems pharmacology · 2023Review
- Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development.Pharmaceutics · 2022Review
- Article
- The future of dry powder inhaled therapy: Promising or discouraging for systemic disorders?International journal of pharmaceutics · 2022Review
- Microencapsulated Isoniazid-Loaded Metal-Organic Frameworks for Pulmonary Administration of Antituberculosis Drugs.Molecules (Basel, Switzerland) · 2021Article
- Particle-based coarse-grained approach for simulating dry powder inhaler.International journal of pharmaceutics · 2021Article
- Wixela Inhub: Dosing PerformanceJournal of aerosol medicine and pulmonary drug delivery · 2020Article
- Simulation Informed Design and Performance of In Vitro Bioequivalence Trials for Particle Size Distributions.The AAPS journal · 2020Article
- Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products.Pharmaceutical medicine · 2020Review
- Assessment and Validation of a Hygroscopic Growth Model with Different Water Activity Estimation Methods.Aerosol science and technology : the journal of the American Association for Aerosol Research · 2020Article
- In Silico Methods for Development of Generic Drug-Device Combination Orally Inhaled Drug Products.CPT: pharmacometrics & systems pharmacology · 2019Review
- Use of computational fluid dynamics deposition modeling in respiratory drug delivery.Expert opinion on drug delivery · 2019Review
- Response to Sharma et al.: Long Pulmonary Residence Time and Plasma Half-Life of Tiotropium: Implications for Pharmacokinetic Bioequivalence Studies.Clinical drug investigation · 2017Article
- Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates.Journal of aerosol medicine and pulmonary drug delivery · 2016Article
- Difference in resistance to humidity between commonly used dry powder inhalers: an in vitro study.NPJ primary care respiratory medicine · 2016Article
- Influence of physical properties of carrier on the performance of dry powder inhalers.Acta pharmaceutica Sinica. B · 2016Review
- Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.The AAPS journal · 2015Article
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dry powder inhalers (DPIs) are used to deliver locally acting drugs (e.g., bronchodilators and corticosteroids) for treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). Demonstrating bioequivalence (BE) for DPI products is challenging, primarily due to an incomplete understanding of the relevance of drug concentrations in blood or plasma to equivalence in drug delivery to the local site(s) of action. Thus, BE of these drug/device combination products is established based on an aggregate weight of evidence, which utilizes in vitro studies to demonstrate equivalence of in vitro performance, pharmacokinetic or pharmacodynamic studies to demonstrate equivalence of systemic exposure, and pharmacodynamic and clinical endpoint studies to demonstrate equivalence in local action. This review discusses key aspects of in vitro studies in supporting the establishment of BE for generic locally acting DPI products. These aspects include comparability in device resistance and equivalence in in vitro testing for single inhalation (actuation) content and aerodynamic particle size distribution.
Indexed as
Identifiers
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.