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Folder 4th Stats and Data

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pdf 2017 IABS Statistics Workshop Summary ( pdf, 366 KB ) (524 downloads)
pdf Areti Manola Going hither and yon ICH Q1E Stability modeling in practice ( pdf, 2.22 MB ) (553 downloads)
pdf Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities ( pdf, 1.21 MB ) (546 downloads)
pdf Dan Obeng Equivalence margin considerations for analytical method transfers ( pdf, 1.27 MB ) (704 downloads)
pdf Dan Weese Ten secrets of a successful nonclinical statistician ( pdf, 1.19 MB ) (505 downloads)
pdf Franz Innerbirchler Simulations to test properties of equivalence testing ( pdf, 1.79 MB ) (483 downloads)
pdf IABS FDA 4th Stats Data Management Meeting 2017 ( pdf, 443 KB ) (489 downloads)
pdf Jose Ramirez Bayesian Tier 1 Statistics ( pdf, 1.21 MB ) (482 downloads)
pdf Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria ( pdf, 824 KB ) (519 downloads)
pdf Laura Pack Trending analysis for stability predicting expiry for annual lot ( pdf, 1.66 MB ) (500 downloads)
pdf Lisa Bernstein Oana Danila From DOEs to CPPs statistics in process development that begins with the end in mind ( pdf, 6.26 MB ) (474 downloads)
pdf Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products ( pdf, 1.14 MB ) (580 downloads)
pdf Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers ( pdf, 910 KB ) (496 downloads)
pdf Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals ( pdf, 720 KB ) (517 downloads)
pdf Meiyu Shen A regulators experience of non clinical statistical interactions with industry ( pdf, 987 KB ) (516 downloads)
pdf Mike Walsh Issues in the satistical inference of stability data ( pdf, 940 KB ) (486 downloads)
pdf Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models ( pdf, 1.37 MB ) (516 downloads)
pdf Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity ( pdf, 906 KB ) (888 downloads)
pdf Roger Hart Estimation of platform process variation from large portfolio datasets Public ( pdf, 1.60 MB ) (494 downloads)
pdf Ruojia Li Analytical Method Performance Monitoring ( pdf, 2.12 MB ) (625 downloads)