D. Christopher

发表

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

David Christopher, Beth Morgan, Ben Forbes, 2015, The AAPS Journal.

Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method

Svetlana Lyapustina, David Christopher, Yi Tsong, 2007, AAPS PharmSciTech.

Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs)

Andrew Cooper, D. Christopher, S. Lyapustina, 2012, AAPS PharmSciTech.

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

Svetlana Lyapustina, Bing Li, Anthony J Hickey, 2010, Journal of aerosol medicine and pulmonary drug delivery.

Product Lifecycle Approach to Cascade Impaction Measurements

Svetlana Lyapustina, Jolyon Mitchell, Terrence P. Tougas, 2011, AAPS PharmSciTech.

A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test

Svetlana Lyapustina, Bruce Wyka, David Christopher, 2009, AAPS PharmSciTech.

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

M. Dolovich, B. Forbes, P. Bäckman, 2015, The AAPS Journal.

Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)

Svetlana Lyapustina, Mike Van Oort, Bruce Wyka, 2009, AAPS PharmSciTech.

On the Shelf Life of Pharmaceutical Products

W. Stroup, M. Quinlan, D. Christopher, 2012, AAPS PharmSciTech.

On the Shelf Life of Pharmaceutical Products

Svetlana Lyapustina, Terrence Tougas, Robert Capen, 2012, AAPS PharmSciTech.

Considerations for the development and practice of cascade impaction testing, including a mass balance failure investigation tree.

Svetlana Lyapustina, Terrence Tougas, Bruce Wyka, 2003, Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine.

Evaluating Current Practices in Shelf Life Estimation

Robert Capen, David Christopher, Patrick Forenzo, 2017, AAPS PharmSciTech.

Performance of the Population Bioequivalence (PBE) Statistical Test with Impactor Sized Mass Data

G. Långström, D. Christopher, Beth Morgan, 2019, AAPS PharmSciTech.

A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 3—Investigation of Robustness to Deviations from Normality

Steven J. Novick, D. Christopher, S. Lyapustina, 2009, AAPS PharmSciTech.

Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers

G. Långström, D. Christopher, Beth Morgan, 2018, AAPS PharmSciTech.

Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers

C. Quale, D. Cipolla, D. Christopher, 2008, AAPS PharmSciTech.

On the Distribution of Batch Shelf Lives

W. Stroup, M. Quinlan, D. Christopher, 2013, Journal of biopharmaceutical statistics.

Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA’s Average Bioequivalence Approach

G. Hochhaus, D. Christopher, Beth Morgan, 2019, AAPS PharmSciTech.