ReviewPharmaceutical medicine2020
Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products.
Review in Pharmaceutical medicine, 2020. 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, 23 citations in OpenAlex.
- Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease.Annals of internal medicine · 2023Trial
- Exploring the challenges faced by generic version of complex drugs: a scoping review.Systematic reviews · 2025Article
- Comprehensive bibliographic study of the framework of complex generic drugs.Journal of Taibah University Medical Sciences · 2025Article
- Experimental Full-volume Airway Approximation for Assessing Breath-dependent Regional Aerosol Deposition.Device · 2024Article
- iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products.Molecular pharmaceutics · 2024Article
- Article
- Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.CPT: pharmacometrics & systems pharmacology · 2023Review
- Localized delivery of nanomedicine and antibodies for combating COVID-19.Acta pharmaceutica Sinica. B · 2023Review
- A new method for investigating bioequivalence of inhaled formulations: A pilot study on salbutamol.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2023Article
- Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development.Pharmaceutics · 2022Review
- Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020.Health affairs (Project Hope) · 2022Article
- Predicting Regional Respiratory Tissue and Systemic Concentrations of Orally Inhaled Drugs through a Novel PBPK Model.Drug metabolism and disposition: the biological fate of chemicals · 2022Article
- Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA.Therapeutic innovation & regulatory science · 2022Article
- Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process.Pharmaceutics · 2021Review
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Generic products offer a considerable cost savings for American consumers and the US healthcare industry. While generics for many products have become available, the approval and adoption of generics for orally inhaled drug products (OIDPs) has lagged behind, owing to the difficulties in bringing these complex generic products to the market. As a complex product, OIDP performance is impacted by numerous factors derived from the product's formulation, delivery to a local site of action within the lung, the performance of the device, and the patient population that uses the medication. Therefore, determining equivalence between generic and brand-name OIDPs requires an approach that considers each of these aspects in order to ensure bioequivalence. FDA's recommended aggregate weight-of-evidence approach for generic OIDPs provides a paradigm where studies and conditions, when taken together, establish equivalence in device performance, systemic exposure, and local drug delivery. This review article covers the various aspects of OIDP complexity, the challenges each presents to equivalence, and FDA's efforts to address these challenges and complex drug development as a whole under the Generic Drug User Fee Amendments (GDUFA). The aggregate weight-of-evidence approach, its rationale, and scientific support is also described.
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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.