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Folder 4th Stats and Data

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  4. 2017 IABS Statistics Workshop Summary

pdf 2017 IABS Statistics Workshop Summary

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2017 IABS Statistics Workshop Summary.pdf

2017 IABS Statistics Workshop Summary
  1. Conferences and Webinars
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  4. Areti Manola Going hither and yon ICH Q1E Stability modeling in practice

pdf Areti Manola Going hither and yon ICH Q1E Stability modeling in practice

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Areti Manola_Going hither and yon-ICH Q1E Stability modeling in practice.pdf

Areti Manola Going hither and yon ICH Q1E Stability modeling in practice
  1. Conferences and Webinars
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  4. Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities

pdf Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities

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Bruno Boulanger_Assessment of Analytical Biosimilarity- The Objective-the Challenge and the Opportunities.pdf

Bruno Boulanger Assessment of Analytical Biosimilarity The Objective the Challenge and the Opportunities
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  4. Dan Obeng Equivalence margin considerations for analytical method transfers

pdf Dan Obeng Equivalence margin considerations for analytical method transfers

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Dan Obeng_Equivalence margin considerations for analytical method transfers.pdf

Dan Obeng Equivalence margin considerations for analytical method transfers
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  4. Dan Weese Ten secrets of a successful nonclinical statistician

pdf Dan Weese Ten secrets of a successful nonclinical statistician

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Dan Weese - Ten secrets of a successful nonclinical statistician.pdf

Dan Weese Ten secrets of a successful nonclinical statistician
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  4. Franz Innerbirchler Simulations to test properties of equivalence testing

pdf Franz Innerbirchler Simulations to test properties of equivalence testing

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Franz Innerbirchler_Simulations to test properties of equivalence testing.pdf

Franz Innerbirchler Simulations to test properties of equivalence testing
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  4. IABS FDA 4th Stats Data Management Meeting 2017

pdf IABS FDA 4th Stats Data Management Meeting 2017

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IABS-FDA_4th Stats Data Management Meeting 2017.pdf

IABS FDA 4th Stats Data Management Meeting 2017
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  4. Jose Ramirez Bayesian Tier 1 Statistics

pdf Jose Ramirez Bayesian Tier 1 Statistics

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Jose Ramirez_Bayesian Tier 1 Statistics.pdf

Jose Ramirez Bayesian Tier 1 Statistics
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  4. Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria

pdf Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria

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Kristi Griffiths_Statistics in the context of clinically relevant commercial specification acceptance criteria.pdf

Kristi Griffiths Statistics in the context of clinically relevant commercial specification acceptance criteria
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  4. Laura Pack Trending analysis for stability predicting expiry for annual lot

pdf Laura Pack Trending analysis for stability predicting expiry for annual lot

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Laura Pack_Trending analysis for stability predicting expiry for annual lot.pdf

Laura Pack Trending analysis for stability predicting expiry for annual lot
  1. Conferences and Webinars
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  4. Lisa Bernstein Oana Danila From DOEs to CPPs statistics in process development that begins with the end in mind

pdf Lisa Bernstein Oana Danila From DOEs to CPPs statistics in process development that begins with the end in mind

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Lisa Bernstein-Oana Danila_From DOEs to CPPs statistics in process development that begins with the end in mind.pdf

Lisa Bernstein Oana Danila From DOEs to CPPs statistics in process development that begins with the end in mind
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  4. Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

pdf Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

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Lixin (Leo) Xu_Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products.pdf

Lixin (Leo) Xu Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products
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  4. Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers

pdf Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers

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Maneesha Altekar_ISPE PQLI PV Team–overview of discussion papers.pdf

Maneesha Altekar ISPE PQLI PV Team–overview of discussion papers
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  4. Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals

pdf Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals

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Mark Johnson_The role of sampling in process validation and comprehensive process verification of biopharmaceuticals.pdf

Mark Johnson The role of sampling in process validation and comprehensive process verification of biopharmaceuticals
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  4. Meiyu Shen A regulators experience of non clinical statistical interactions with industry

pdf Meiyu Shen A regulators experience of non clinical statistical interactions with industry

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Meiyu Shen_A regulators experience of non-clinical statistical interactions with industry.pdf

Meiyu Shen A regulators experience of non clinical statistical interactions with industry
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  4. Mike Walsh Issues in the satistical inference of stability data

pdf Mike Walsh Issues in the satistical inference of stability data

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Mike Walsh_Issues in the satistical inference of stability data.pdf

Mike Walsh Issues in the satistical inference of stability data
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  4. Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models

pdf Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models

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Perceval Sondag_A fit-for-purpose perspective on shelf-life and internal release limits determination-objectives and models.pdf

Perceval Sondag A fit for purpose perspective on shelf life and internal release limits determination objectives and models
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  4. Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity

pdf Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity

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Rick Burdick_PPQ Criteria for Inter-and Intra-batch variability and assessment of homogeneity.pdf

Rick Burdick PPQ Criteria for Inter and Intra batch variability and assessment of homogeneity
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  4. Roger Hart Estimation of platform process variation from large portfolio datasets Public

pdf Roger Hart Estimation of platform process variation from large portfolio datasets Public

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Roger Hart_Estimation of platform process variation from large-portfolio datasets_Public.pdf

Roger Hart Estimation of platform process variation from large portfolio datasets Public
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  4. Ruojia Li Analytical Method Performance Monitoring

pdf Ruojia Li Analytical Method Performance Monitoring

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Ruojia Li_Analytical Method Performance Monitoring.pdf

Ruojia Li Analytical Method Performance Monitoring
 

 

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