Calibration curves in quantitative ligand binding assays: recommendations and best practices for preparation, design, and editing of calibration curves M Azadeh, B Gorovits, J Kamerud, S MacMannis, A Safavi, J Sailstad, ... The AAPS journal 20, 1-16, 2018 | 51 | 2018 |
Analytical procedure validation and the quality by design paradigm E Rozet, P Lebrun, JF Michiels, P Sondag, T Scherder, B Boulanger Journal of biopharmaceutical statistics 25 (2), 260-268, 2015 | 31 | 2015 |
Quality controls in ligand binding assays: recommendations and best practices for preparation, qualification, maintenance of lot to lot consistency, and prevention of assay drift M Azadeh, P Sondag, Y Wang, M Raines, J Sailstad The AAPS journal 21, 1-14, 2019 | 13 | 2019 |
Quality by design applied in formulation development and robustness P Lebrun, P Sondag, X Lories, JF Michiels, E Rozet, B Boulanger Statistics for Biotechnology Process Development, 77-92, 2018 | 9 | 2018 |
Effect of a statistical outlier in potency bioassays P Sondag, L Zeng, B Yu, R Rousseau, B Boulanger, H Yang, S Novick Pharmaceutical statistics 17 (6), 701-709, 2018 | 6 | 2018 |
Assay validation P Sondag, P Lebrun, E Rozet, B Boulanger Nonclinical Statistics for Pharmaceutical and Biotechnology Industries, 415-432, 2016 | 6 | 2016 |
Comparisons of outlier tests for potency bioassays P Sondag, L Zeng, B Yu, H Yang, S Novick Pharmaceutical statistics 19 (3), 230-242, 2020 | 5 | 2020 |
The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASA‐BIOP Nonclinical Bayesian Working Group P Faya, P Sondag, S Novick, D Banton, JW Seaman, Jr, JD Stamey, ... Pharmaceutical Statistics 20 (2), 245-255, 2021 | 4 | 2021 |
Comment and completion: implementation of parallelism testing for four-parameter logistic model in bioassays P Sondag, R Joie, H Yang PDA journal of pharmaceutical science and technology 69 (4), 467-470, 2015 | 4 | 2015 |
A novel method for qualification of a potency assay through partial computer simulation S Novick, P Sondag, T Schofield, K Miller PDA journal of pharmaceutical science and technology 72 (3), 249-263, 2018 | 2 | 2018 |
Risk-based similarity testing for potency assays using mcmc simulations P Sondag, P Lebrun Statistics in Biopharmaceutical Research 13 (3), 303-312, 2021 | 1 | 2021 |
Bayesian Alternatives to Traditional Methods for Estimating Product Shelf-Life and Internal Release Limits P Sondag, JY Kim, L Natalis, T Scherder Case Studies in Bayesian Methods for Biopharmaceutical CMC, 225-256, 2022 | | 2022 |
Contribution to Statistical Similarity Testing in Potency Assays P Sondag ULiège-University of Liège, Belgium, 2020 | | 2020 |