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Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs)
TLDR
The purpose of this article is to review the suitability of the analytical and statistical techniques that have thus far been developed to assess the dissolution behavior of particles in the respirable aerodynamic size range, as generated by orally inhaled products (OIPs) such as metered-dose inhalers and dry powder inhalers. Expand
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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method
TLDR
The purpose of this article is 2-fold: (1) to document in the public domain the considerations that led to the development of a regulatory statistical test for comparison of aerodynamic particle size distribution (APSD) of aerosolized drug formulations, which was proposed in a US Food and Drug Administration (FDA) draft guidance for industry; and (2) to explain the background and process for evaluation of that test through a working group. Expand
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In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches
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 FloridaExpand
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A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test
The FDA proposed a parametric tolerance interval (PTI) test at the October 2005 Advisory Committee meeting as a replacement of the attribute (counting) test for delivered dose uniformity (DDU),Expand
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Defect generation and pileup of atoms during nanoindentation of Fe single crystals
Complementary large scale molecular-dynamics simulations and experiments have been carried out to determine the atomistic mechanisms of the nanoindentation process in single crystal Fe{110}, {100},Expand
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Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence
TLDR
The purpose of this article is to report final results of the evaluation of a chi-square ratio test proposed by the US Food and Drug Administration (FDA) for demonstrating equivalence of aerodynamic particle size distribution (APSD) profiles of nasal and orally inhaled drug products. Expand
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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 2—Evaluation of a method for determining equivalence
TLDR
The purpose of this article is to present the thought process, methods, and interim results of a PQRI Working Group, which was charged with evaluating the chi-square ratio test as a potential method for determining in vitro equivalence of aerodynamic particle size distribution (APSD) profiles obtained from cascade impactor measurements. Expand
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Differences in the process of diabetic care between south Asian and white patients in inner-city practices in Nottingham, UK.
The prevalence and complication rate of diabetes is higher amongst British south Asians when compared to the rest of the adult population. There is some evidence to suggest that there are differencesExpand
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Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)
This study of aerodynamic mass-weighted particle size distribution (APSD) data from orally inhaled products (OIPs) investigated whether a set of simpler (than currently used) metrics may be adequateExpand
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Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers
This article reports performance characteristics of the population bioequivalence (PBE) statistical test recommended by the US Food and Drug Administration (FDA) for orally inhaled products. A PBEExpand
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