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 ) (2620 downloads)
pdf Areti Manola Going hither and yon ICH Q1E Stability modeling in practice ( pdf, 2.22 MB ) (2333 downloads)
pdf Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities ( pdf, 1.21 MB ) (3844 downloads)
pdf Dan Obeng Equivalence margin considerations for analytical method transfers ( pdf, 1.27 MB ) (9486 downloads)
pdf Dan Weese Ten secrets of a successful nonclinical statistician ( pdf, 1.19 MB ) (2158 downloads)
pdf Franz Innerbirchler Simulations to test properties of equivalence testing ( pdf, 1.79 MB ) (2618 downloads)
pdf IABS FDA 4th Stats Data Management Meeting 2017 ( pdf, 443 KB ) (2572 downloads)
pdf Jose Ramirez Bayesian Tier 1 Statistics ( pdf, 1.21 MB ) (2710 downloads)
pdf Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria ( pdf, 824 KB ) (3092 downloads)
pdf Laura Pack Trending analysis for stability predicting expiry for annual lot ( pdf, 1.66 MB ) (3983 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 ) (2613 downloads)
pdf Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products ( pdf, 1.14 MB ) (5160 downloads)
pdf Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers ( pdf, 910 KB ) (3841 downloads)
pdf Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals ( pdf, 720 KB ) (3837 downloads)
pdf Meiyu Shen A regulators experience of non clinical statistical interactions with industry ( pdf, 987 KB ) (3053 downloads)
pdf Mike Walsh Issues in the satistical inference of stability data ( pdf, 940 KB ) (2437 downloads)
pdf Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models ( pdf, 1.37 MB ) (3985 downloads)
pdf Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity ( pdf, 906 KB ) (12619 downloads)
pdf Roger Hart Estimation of platform process variation from large portfolio datasets Public ( pdf, 1.60 MB ) (2915 downloads)
pdf Ruojia Li Analytical Method Performance Monitoring ( pdf, 2.12 MB ) (2777 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.