Publications of interest

Bernhard Schmelzer, AndrÉ Mischo, Franz Innerbichler. Statistically Significant versus Practically Relevant Trend in Stability Data PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 341-356; DOI: 10.5731/pdajpst.2020.012336

Richard O. Montes, Richard K. Burdick, David J. Leblond. Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 39-59; DOI: 10.5731/pdajpst.2018.008839

Todd Coffey & Keith Bower (2017), A Statistical Approach to Assess and Justify Potential Product Specifications BioProcess International.  

Xiaoyu Dong, Yi Tsong & Meiyu Shen (2015) Statistical Considerations in Setting Product Specifications, Journal of Biopharmaceutical Statistics, 25:2, 280-294,  http://dx.doi.org/10.1080/10543406.2014.972511  

Bower, K.M. (2017), Tier 1 Biosimilarity Assessments - A Practical Illustration, 2017 CASSS Bioassay Conference

Meiyu Shen, Lixin L. Xu, Design and statistical analysis of method transfer studies for biotechnology products, Bioanalysis, Vol. 9 No. 8, May 2017. https://doi.org/10.4155/bio-2017-0015 

Lawrence X. Yu, Daniel Y. Peng, Robert Lionberger, Alex Viehmann and Karthik Iyer (2015), Using Process Capability To Ensure Pharmaceutical Product Quality. Pharmaceutical Engineering, Vol 85 No. 2, pp 35-43.

Bates, R. (2014), Current Best Practices in the Definition of Process Parameters for Development of Control Strategies. CASSS CMC Strategy Forum Europe.

Bower, K.M., Germansderfer, A., Kerwin, B.A., Kleemann, G.R. and Litowski, J.R. (2011), Designed Experiments with Binary Responses J. Pharm. Sci., 100: 5078–5079.

He, F., Woods, C.E., Trilisky, E., Bower, K.M., Litowski, J.R., Kerwin, B.A., Becker, G.W., Narhi, L.O. and Razinkov, V.I. (2011), Screening of Monoclonal Antibody Formulations based on High-Throughput Thermostability and Viscosity Measurements: Design of Experiment and Statistical Analysis J. Pharm. Sci., 100: 1330–1340.