James Bergum
DNA Diagnostics Center (United States)(US)
Publications by Year
Research Areas
Advanced Statistical Process Monitoring, Drug Solubulity and Delivery Systems, Pharmaceutical studies and practices, Spectroscopy and Chemometric Analyses, Fault Detection and Control Systems
Most-Cited Works
- → Evaluation of the Performance Characteristics of Bilayer Tablets: Part I. Impact of Material Properties and Process Parameters on the Strength of Bilayer Tablets(2012)46 cited
- → Recommendations for the Assessment of Blend and Content Uniformity: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance(2014)40 cited
- → An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design(2010)37 cited
- → Constructing Acceptance Limits for Multiple Stage Tests(1990)27 cited
- → Bead Manufacture by Extrusion/spheronization – a Statistical Design for Process Optimization(1993)27 cited
- → An evaluation of microcrystalline cellulose and lactose excipients using an instrumented single station tablet press(1994)23 cited
- → Effects of different types of lactose and disintegrant on dissolution stability of hydrochlorothiazide capsule formulations(1994)22 cited
- → Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810(2014)20 cited
- → Application of quality by design (QbD) to the development and validation of analytical methods(2013)19 cited
- → Evaluation of the Performance Characteristics of Bilayer Tablets: Part II. Impact of Environmental Conditions on the Strength of Bilayer Tablets(2012)15 cited