Следене
Perceval Sondag
Perceval Sondag
Потвърден имейл адрес: merck.com
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Позовавания
Позовавания
Година
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
612018
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
362015
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
202019
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
92018
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
82018
Comparisons of outlier tests for potency bioassays
P Sondag, L Zeng, B Yu, H Yang, S Novick
Pharmaceutical statistics 19 (3), 230-242, 2020
72020
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
62021
Assay validation
P Sondag, P Lebrun, E Rozet, B Boulanger
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries, 415-432, 2016
62016
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
42015
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
22018
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
12022
Risk-Based Similarity Testing for Potency Assays Using MCMC Simulations
P Sondag, P Lebrun
Statistics in Biopharmaceutical Research 13 (3), 303-312, 2021
12021
Contribution to Statistical Similarity Testing in Potency Assays
P Sondag
ULiège-University of Liège, Belgium, 2020
2020
BEBPA Blog
P Sondag
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