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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2016 1:00 PM - Apr 27, 2016 4:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics 2016 Forum

Now in its tenth year, the Forum fosters open discussion of timely topics of mutual theoretical and practical interest to biostatisticians and clinical trialists.

Networking Reception and Poster Session

Session Chair(s)

Poster  Session

Poster Session

United States

Comparison of Dissolution Profiles: A Statistician's Perspective
Thomas Hoffelder
Statistician
Boehringer Ingelheim Pharma Gmbh & Co. KG,Germany

Sample Size Determination in Clincal Trials with Two Time-to-Event Outcomes
Toshimitsu Hamasaki, PhD, MS
Chief at Office of Biostatistics and Data Management
National Cerebral and Cardiovascular Center, Japan

Drug Pharmacokinetics-ECG Correlation in the Dynamic Clinical Study Environment – Evaluation of Contributing Factors
Galina Bernstein, PhD
Research Scientist, PK, Scientific Affairs
INC Research
Canada

Development of Methods for Shelf-Life Determination with Large Number of Batches
Sungwoo Choi, PhD
Mathematical Statistician
FDA, United States

Some Statistical Issues in Concentration-QTc Modeling
Dalong Huang, PhD
Mathematical Statisitician
FDA, United States

Enabling Activities to Find Predictive Biomarkers
Rosalind Jane Walley, MA
Statistician
UCB Celltech, United Kingdom

Bioequivalence Evaluation of Sparse Sampling Data Using Bootstrap Resampling Method
Meiyu Shen, PhD
Mathematics Statistician, Office of Translational Sciences, CDER
FDA, United States

Using Bayesian Statistical Methods to Reduce Resources and Improve Decision Making Processes in Early Development at UCB
Foteini Strimenopoulou, PhD
Principal Statistician
UCB Pharma, United Kingdom

Statistical Considerations for Evaluating Abuse Deterrent Opioids in Human Abuse Potential Studies
Catherine Ann Mills, MSc
Principal Data Analyst
INC Research, Canada

Scopes and Utilization of PET/CT Tomographic Images in Phase I, and II Clinical Studies
Altaf Khan, MS, MSc
Biostatisticain
King Abdullah International Medical Resaerch Center, United States

Statistical Issues of Using Adaptive and Group Sequential Designs in PK Crossover Studies
Yu-Ting Weng, PhD
FDA, United States

Development of Statistical Methods for Parallelism Test of Bioassays
Cassie Dong, PhD
Mathematical Statistician, Division of Biometrics VI, OTS, CDER
FDA, United States

Statistical Approaches of the Equivalence Test Using a Function of Reference Product Varience as Margin
Cassie Dong, PhD
Mathematical Statistician, Division of Biometrics VI, OTS, CDER
FDA, United States

How Statistics can Reduce the Damage from a Fraud in Clinical Trials
Giulia Tonini, PhD
External Expert Evaluator
Menarini-Ricerche, Italy

The Roadmap of Osteogenesis Imperfecta in Athens Greece. From Child to Adulthood. An ITINERAR E
Androniki Drakou, MD, PhD
Consultant Orthopaedic Surgeon
Attikon University Hospital, Greece

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