FreeThink Publications
A. Sheng-Chu Leon, K.Waterman, G.Wang, L. Wang, T, Cai, X. Zhang et al. “Accelerated stability modeling of recrystallization from amorphous solid
Dispersions: A Griseofulvin/HPMC-AS case study”
International Journal of Pharmaceutices
May 2024
K.Waterman, et al. “Mechanism Changes with High Temperature: Significance for Use of Accelerated Aging Modeling of Pharmaceuticals“
Journal of Pharmaceutical Innovation
October 2023
K.Flavier, J.McLellan, T.Botoy, K.Waterman, et al. “Accelerated shelf life modeling of appearance change in drug products using ASAPprime®”
Pharmaceutical Development and Technology
August 2022
K. Waterman, et al. “Stability screening of pharmaceutical cocrystals”
Pharmaceutical Development and Technology
November 2021
K. Waterman, et al. “Stability screening of pharmaceutical cocrystals”
Pharmaceutical Development and Technology
November 2021
M. Krisch, et al. “Case study: Activ-Blister™ solutions provide superior protection of a model drug product over cold-form foil”
PharmaChem: Pharma Industry
March/April 2020
M. Krisch, et al. “Case study: Activ-Blister™ solutions provide superior protection of a model drug product over cold-form foil”
PharmaChem: Pharma Industry
March/April 2020
M. Knopp “Stability Modeling and Package Selection”
Tablets & Capsules: CSC Publishing Inc.
May 2016
R. Waterman, et al. “Accelerated Stability Modeling for Peptides: a Case Study with Bacitracin”
AAPS PharmSciTech
October 2016
K. Waterman, et al. “Modeling of in-use stability for tablets and powders in bottles”
Drug Development & Industrial Pharmacy: Volume 42, Issue 10
April 2016
K. Waterman, et al. “Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging”
PharmTech: Pharmaceutical Technology: Volume 2017 Supplement, Issue 4
September 2017
S. Colgan, et al. “Lean Stability”
AAPS News Magazine
September 2015
K. Waterman, et al. “A scientific and statistical analysis of accelerated aging for pharmaceuticals. Part 1: accuracy of fitting methods.”
National Center for Biotechnology Information; US National Library of Medicine; National Institutes of Health; PubMed.gov
October 2014
K. Waterman, et al. “Impact of sertraline salt form on the oxidative stability in powder blends”
International Journal of Pharmaceutics: Volume 461, Issues 1-2
January 2014
K. Waterman, et al. “A Generalized Relation for Solid-State Drug Stability as a Function of Excipient Dilution: Temperature-Independent Behavior”
Journal of Pharmaceutical Sciences: Volume 101, Issue 11
November 2012
K. Waterman, et al. “Relative Humidity Hysteresis in Solid-State Chemical Reactivity: A Pharmaceutical Case Study”
Journal of Pharmaceutical Sciences: Volume 101, Issue 2
February 2012
K. Waterman “The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability”
AAPS PharmSciTech
July 2011
K. Waterman, et al. “Osmotic capsules: A universal oral, controlled-release drug delivery dosage form”
Journal of Controlled Release: Volume 152, Issue 2
June 2011
K. Waterman, et al. “Package Selection for Moisture Protection for Solid, Oral Drug Products”
Journal of Pharmaceutical Sciences: Volume 99, Issue 11
November 2010
K. Waterman “Understanding and Predicting Pharmaceutical Product Shelf-Life”
Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
2009
K. Waterman, et al. “Use of scoring to induce reproducible drug delivery from osmotic pulsatile tablets”
Pharmaceutical Development & Technology: Volume 14, Issue 5
March 2009
K. Waterman, et al. “Extrudable core system: Development of a single-layer osmotic controlled-release tablet”
Journal of Controlled Release: Volume 134, Issue 3
March 2009
K. Waterman “A Critical Review of Gastric Retentive Controlled Drug Delivery”
Pharmaceutical Development & Technology: Volume 12, Issue 1
October 2008
K. Waterman, et al. “N‐methylation and N‐formylation of a secondary amine drug (varenicline) in an osmotic tablet”
Journal of Pharmaceutical Sciences: Volume 97, Issue 4
April 2008
K. Waterman, et al. “Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage Forms”
Pharmaceutical Research (AAPS)
February 2007
K. Waterman, et al. “Accelerated aging: Prediction of chemical stability of pharmaceuticals”
International Journal of Pharmaceutics: Volume 293, Issues 1-2
April 2005
K. Waterman, et al. “Impurities in Drug Products”
Separation Science and Technology: Handbook of Isolation and Characterization of Impurities in Pharmaceuticals: Volume 5
2003
K. Waterman, et al. “Press-coating of immediate release powders onto coated controlled release tablets with adhesives”
Journal of Controlled Release: Volume 89, Issue 3
May 2003
K. Waterman, et al. “Hydrolysis in Pharmaceutical Formulations”
Pharmaceutical Development & Technology: Volume 7, Issue 2
May 2002
K. Waterman, et al. “Use of Oxygen Scavengers to Stabilize Solid Pharmaceutical Dosage Forms: A Case Study”
Pharmaceutical Development & Technology: Volume 7, Issue 2
May 2002
K. Waterman, et al. “Stabilization of Pharmaceuticals to Oxidative Degradation”
Pharmaceutical Development & Technology: Volume 7, Issue 1
April 2002