ReviewThe AAPS journal2015
In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches.
Review in The AAPS journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Particle size and gastrointestinal absorption influence tiotropium pharmacokinetics: a pilot bioequivalence study of PUR0200 and Spiriva HandiHaler.British journal of clinical pharmacology · 2019Trial
- Pharmacokinetics of the Inhaled Selective Glucocorticoid Receptor Modulator AZD5423 Following Inhalation Using Different Devices.The AAPS journal · 2017Trial
- Particle dissolution rate controls macrophage response and drug release from mesoporous silica inhalation carriers.Scientific reports · 2026Article
- Nicotine flux and pharmacokinetics-based considerations for early assessment of nicotine delivery systems.Drug and alcohol dependence reports · 2024Article
- In Vitro Dissolution and Permeability Testing of Inhalation Products: Challenges and Advances.Pharmaceutics · 2023Review
- How to engineer aerosol particle properties and biopharmaceutical performance of propellant inhalers.International journal of pharmaceutics · 2023Article
- Nano-in-Microparticles for Aerosol Delivery of Antibiotic-Loaded, Fucose-Derivatized, and Macrophage-Targeted Liposomes to Combat Mycobacterial Infections: In Vitro Deposition, Pulmonary Barrier Interactions, and Targeted Delivery.Advanced healthcare materials · 2022Article
- RespiCellPharmaceutics · 2021Article
- Optimization of the TranswellPharmaceutics · 2021Article
- Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process.Pharmaceutics · 2021Review
- Preclinical Development of Orally Inhaled Drugs (OIDs)-Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?Animals : an open access journal from MDPI · 2020Article
- Biological Obstacles for IdentifyingPharmaceutics · 2019Review
- A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Article
- In Vivo-Relevant Transwell Dish-Based Dissolution Testing for Orally Inhaled Corticosteroid Products.Pharmaceutical research · 2019Article
- Design and development of a biorelevant simulated human lung fluid.Journal of drug delivery science and technology · 2018Article
- Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.Clinical pharmacokinetics · 2017Review
- Effect of the Route of Administration and PEGylation of Poly(amidoamine) Dendrimers on Their Systemic and Lung Cellular Biodistribution.Molecular pharmaceutics · 2016Article
- Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.The AAPS journal · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This article is part of a series of reports from the "Orlando Inhalation Conference-Approaches in International Regulation" which was held in March 2014, and coorganized by the University of Florida and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The goal of the conference was to foster the exchange of ideas and knowledge across the global scientific and regulatory community in order to identify and help move towards strategies for internationally harmonized, science-based regulatory approaches for the development and marketing approval of inhalation medicines, including innovator and second entry products. This article provides an integrated perspective of case studies and discussion related to in vitro testing of orally inhaled products, including in vitro-in vivo correlations and requirements for in vitro data and statistical analysis that support quality or bioequivalence for regulatory applications.
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.