Documents

  1. Conferences and Webinars
    2. »
  2. 2017
    3. »
  3. 4th Stats and Data

Folder 4th Stats and Data

Select Toggle Title Date
pdf 2017 IABS Statistics Workshop Summary ( pdf, 366 KB ) (1938 downloads)
pdf Areti Manola Going hither and yon ICH Q1E Stability modeling in practice ( pdf, 2.22 MB ) (2217 downloads)
pdf Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities ( pdf, 1.21 MB ) (2861 downloads)
pdf Dan Obeng Equivalence margin considerations for analytical method transfers ( pdf, 1.27 MB ) (8550 downloads)
pdf Dan Weese Ten secrets of a successful nonclinical statistician ( pdf, 1.19 MB ) (2034 downloads)
pdf Franz Innerbirchler Simulations to test properties of equivalence testing ( pdf, 1.79 MB ) (2208 downloads)
pdf IABS FDA 4th Stats Data Management Meeting 2017 ( pdf, 443 KB ) (2026 downloads)
pdf Jose Ramirez Bayesian Tier 1 Statistics ( pdf, 1.21 MB ) (2067 downloads)
pdf Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria ( pdf, 824 KB ) (2414 downloads)
pdf Laura Pack Trending analysis for stability predicting expiry for annual lot ( pdf, 1.66 MB ) (3090 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 ) (1894 downloads)
pdf Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products ( pdf, 1.14 MB ) (4838 downloads)
pdf Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers ( pdf, 910 KB ) (2922 downloads)
pdf Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals ( pdf, 720 KB ) (2802 downloads)
pdf Meiyu Shen A regulators experience of non clinical statistical interactions with industry ( pdf, 987 KB ) (2265 downloads)
pdf Mike Walsh Issues in the satistical inference of stability data ( pdf, 940 KB ) (1876 downloads)
pdf Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models ( pdf, 1.37 MB ) (2951 downloads)
pdf Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity ( pdf, 906 KB ) (10945 downloads)
pdf Roger Hart Estimation of platform process variation from large portfolio datasets Public ( pdf, 1.60 MB ) (2269 downloads)
pdf Ruojia Li Analytical Method Performance Monitoring ( pdf, 2.12 MB ) (2206 downloads)
 

 

IABS
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.