Folder 2nd Stats & Data

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pdf Binbing Yu - MedImmune Popular

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Binbing Yu_MedImmune.pdf

Binbing Yu - MedImmune
Evaluating the comparability of stability at long-term storage temperatures using accelerated stability data

pdf Daniel Coleman - Genentech Popular

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Daniel Coleman_Genentech.pdf

Daniel Coleman - Genentech
Design and analysis of method validation experiments

pdf Harry Yang - MedImmune Popular

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Harry Yang_MedImmune.pdf

Harry Yang - MedImmune
A new Bayesian perspective for justifying sample size for PPQ

pdf Jochen Giese - GSK Vaccines Popular

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Jochen Giese_GSK Vaccines.pdf

Jochen Giese - GSK Vaccines
Novel data analysis method for Continued Process Verification using change-point analysis

pdf Julia O'Neill - Tunnell Consulting Popular

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Julia O'Neill_Tunnell Consulting.pdf

Julia O'Neill - Tunnell Consulting
Statistical support for continued process verification

pdf Katherine Giacoletti - Arlenda Popular

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Katherine Giacoletti_Arlenda.pdf

Katherine Giacoletti - Arlenda
A Bayesian approach to method bridging

pdf Kimber Barnett - Pfizer Popular

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Kimber Barnett_Pfizer.pdf

Kimber Barnett - Pfizer
Method design: benefits of collaboration between statisticians and analytical chemists

pdf Mark DiMartino - Amgen Popular

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Mark DiMartino_Amgen.pdf

Mark DiMartino - Amgen
The practical difference between Ppk and Cpk

pdf Richard K Burdick - Amgen Popular

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Richard K. Burdick_Amgen.pdf

Richard K  Burdick - Amgen
Statistical details of analytical similarity for biosimilars: an industry view

pdf Roger Hart - Amgen Popular

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Roger Hart_Amgen.pdf

Roger Hart - Amgen
Applications of Bayes statistical methods to infer limits from historical platform data

pdf Session 1 - Questions for discussion Popular

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Session 1_Questions for discussion.pdf

pdf Session 2 - Questions for discussion Popular

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Session 2_Questions for discussion.pdf

pdf Session 3 - Questions for discussion Popular

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Session 3_Questions for discussion.pdf

pdf Session 4 - Questions for discussion Popular

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Session 4_Questions for discussion.pdf

pdf Sheng Feng - AbbVie Popular

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Sheng Feng_AbbVie.pdf

Sheng Feng - AbbVie
Impact of measurement error in biomarker evaluations and performance

pdf Stanley Deming - Statistical Designs Popular

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Stanley Deming_Statistical Designs.pdf

Stanley Deming - Statistical Designs
Issues with the ubiquitous use of the 4PL model during product development (and after)

pdf Steve Stein - NIST Popular

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Steve Stein_NIST.pdf

Steve Stein - NIST
Developing tandem mass spectral libraires of individual proteins

pdf Xiaoyu (Cassie) Dong - FDA Popular

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Xiaoyu (Cassie) Dong-FDA.pdf

Xiaoyu (Cassie) Dong - FDA
Statistical approaches for analytical biosimilarity evaluation

pdf Yi Tsong - FDA Popular

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Yi Tsong_FDA.pdf

Yi Tsong - FDA
Equivalence margin determination for analytical biosimilar assessment

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