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Richard K. Burdick. (2021) Statistical Considerations for Comparative Assessment of Quality Attributes. Statistics in Biopharmaceutical Research 13:3, pages 297-302.
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Zoltan Papp. (1992) Two- sided tolerance limits and confidence bounds for normal populations. Communications in Statistics - Theory and Methods 21:5, pages 1309-1318.
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Articles from other publishers (20)
Steffi Höse & Stefan HuschensSteffi Höse & Stefan Huschens. 2022. Ereignisrisiko. Ereignisrisiko
65
141
.
Chih‐Ming Hsieh, Stephen M. Howell & Maury L. Hull. (2020)
Errors in femoral anteversion, femoral offset, and vertical offset following
robot‐assisted
total hip arthroplasty
. The International Journal of Medical Robotics and Computer Assisted Surgery 16:4.
Crossref
Crossref
R. El Hajji, A. Boussetta, B. Aznag, F. Agdouz, B. Ihssane, O.A. Hamedane & T. Saffaj. (2018) Comparison of fit for a future purpose concept based on tolerance interval and ISO 11352 approaches to predict the quantitative performances and routine uncertainty of an ICP-MS method for the determination of 21 elements in drinking water. Microchemical Journal 138, pages 255-265.
Crossref
Crossref
Chih Ming Hsieh, Stephen M. Howell & Maury L. Hull. (2017) What are the six degree-of-freedom errors of a robotically-machined femoral cavity in total hip arthroplasty and are they clinically important? An in-vitro study. Medical Engineering & Physics 48, pages 120-130.
Crossref
Crossref
F. Varenne, E. Rustique, J. Botton, J.-B. Coty, G. Lanusse, M. Ait Lahcen, L. Rio, C. Zandanel, C. Lemarchand, M. Germain, L. Negri, A.-C. Couffin, G. Barratt & C. Vauthier. (2017) Towards quality assessed characterization of nanomaterial: Transfer of validated protocols for size measurement by dynamic light scattering and evaluation of zeta potential by electrophoretic light scattering. International Journal of Pharmaceutics 528:1-2, pages 299-311.
Crossref
Crossref
Daniel P. Bonny, Stephen M. Howell & Maury L. Hull. (2017) Changes in the rotational axes of the tibiofemoral joint caused by resection of the anterior cruciate ligament. Journal of Orthopaedic Research 35:4, pages 886-893.
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Crossref
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju ZhangRichard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju Zhang. 2017. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
11
113
.
Jérémie Kindenge Mbinze, Jean Nsangu Mpasi, Elza Maghe, Sébastien Kobo, Rodrigue Mwanda, Guy Mulumba, Jacquie Bolavie Bolande, Trésor Menanzambi Bayebila, Maguy Borive Amani, Philippe Hubert & Roland Djang’eing’a Marini. (2015) Application of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines. American Journal of Analytical Chemistry 06:02, pages 106-117.
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Mohammed Amood AL-Kamarany, Miloud EL Karbane, Khadija Ridouan, Fars K. Alanazi, Philippe Hubert, Yahia Cherrah & Abdelaziz Bouklouze. (2012) Transfer of drug dissolution testing by statistical approaches: Case study. Saudi Pharmaceutical Journal 20:1, pages 93-101.
Crossref
Crossref
Laura Zufía, Azucena Aldaz, Nerea Ibáñez, Joaquín Giráldez & César Viteri. (2010) LC method for therapeutic drug monitoring of levetiracetam: Evaluation of the assay performance and validation of its application in the routine area. Clinical Biochemistry 43:4-5, pages 473-482.
Crossref
Crossref
Bruno Boulanger, Viswanath Devanarayan & Walthère Dewè. 2009. Ligand‐Binding Assays. Ligand‐Binding Assays
111
128
.
David Hoffman. (2009) Statistical Considerations for Assessment of Bioanalytical Incurred Sample Reproducibility. The AAPS Journal 11:3.
Crossref
Crossref
Bruno Boulanger, Eric Rozet, François Moonen, Serge Rudaz & Philippe Hubert. (2009) A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. Journal of Chromatography B 877:23, pages 2235-2243.
Crossref
Crossref
L. Zufía, A. Aldaz, N. Ibáñez & C. Viteri. (2009) LC method for the therapeutic drug monitoring of lamotrigine: Evaluation of the assay performance and validation of its application in the routine area. Journal of Pharmaceutical and Biomedical Analysis 49:2, pages 547-553.
Crossref
Crossref
Bernadette Govaerts, Walthère Dewé, Myriam Maumy & Bruno Boulanger. (2008) Pre‐study analytical method validation: comparison of four alternative approaches based on quality‐level estimation and tolerance intervals. Quality and Reliability Engineering International 24:6, pages 667-680.
Crossref
Crossref
Frédéric Bertrand & Myriam Maumy. (2007) Développements d'Edgeworth de deux estimateurs d'une proportion de mesures. Comptes Rendus Mathematique 345:7, pages 399-404.
Crossref
Crossref
Walthère Dewé, Michaël De Smet, Nathalie Evrard, Benoit Culot, Marc Lastelle, Gaëlle Saucez, Dominique Ingels & Xavier Taillieu. (2007) Partial within-animal calibration: A new calibration approach in lead optimisation high-throughput bioanalysis. Journal of Chromatography B 854:1-2, pages 183-191.
Crossref
Crossref
Bruno Boulanger, Walthère Dewé, Aurélie Gilbert, Bernadette Govaerts & Myriam Maumy-Bertrand. (2007) Risk management for analytical methods based on the total error concept: Conciliating the objectives of the pre-study and in-study validation phases. Chemometrics and Intelligent Laboratory Systems 86:2, pages 198-207.
Crossref
Crossref
W. Dewé, B. Govaerts, B. Boulanger, E. Rozet, P. Chiap & Ph. Hubert. (2007) Using total error as decision criterion in analytical method transfer. Chemometrics and Intelligent Laboratory Systems 85:2, pages 262-268.
Crossref
Crossref
Roland Djang’eing’a Marini, Anne-Catherine Servais, Eric Rozet, Patrice Chiap, Bruno Boulanger, Serge Rudaz, Jacques Crommen, Philippe Hubert & Marianne Fillet. (2006) Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of S-timolol using heptakis(2,3-di-O-methyl-6-O-sulfo)-β-cyclodextrin: Validation using the accuracy profile strategy and estimation of uncertainty. Journal of Chromatography A 1120:1-2, pages 102-111.
Crossref
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