Resources

Chemistry, Manufacturing, and Controls (CMC) Statistics

Publications of interest

Stability Studies

Bernhard Schmelzer, AndrÉ Mischo and 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

Specification Acceptance Criteria

Richard O. Montes, Richard K. Burdick and 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 M. 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

Keith M. Bower (2020), Biopharmaceutical Product Specification Limits and Autocorrelated Data, BioProcess International.

Keith M. Bower (2022), Appropriate Estimation of Long-Term Variability: Using Biopharmaceutical Release and Stability Data, BioProcess International.

Comparability/Biosimilarity

Meiyu Shen and 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

Keith M. Bower (2012), Practical Interpretation of Equivalence Acceptance Criteria, Genetic Engineering and Biotechnology News, Vol. 32, No. 4.

Keith M. Bower and Abraham Germansderfer (2012), Assessing Comparability Based on Limited Data, Quality Progress.

Continued Process Verification (CPV)

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.

Keith M. Bower (2019), Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data, BioProcess International

Keith M. Bower (2020), Run Rules with Autocorrelated Data for Continued Process Verification, BioProcess International

Keith M. Bower (2020), Practical Considerations for Statistical Analyses in Continued Process Verification, BioProcess International

Design of Experiments (DOE)

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.