PPT-Sample size optimization in BA and BE trials using a Bayesi

Paul Meyvisch An Vandebosch BAYES 2014 London 13 June 2014 Background PK Pharmacokinetics Bioavailability BA expressed as AUC area under the concentration curve C max. the statistics right for integrative research involving . Ayurveda. Ashwini Mathur. (Novartis Healthcare Pvt. Ltd, Hyderabad). August 1, 2013, . Samyukti. 2013. 1. Disclaimer/Acknowledgements. All views expressed are authors’ and do not reflect the views of Novartis.. Challenging Tradition. Chia-Chi (Josh) Lin, MD, PhD . 林家齊. Director of Phase I Center, Department of Oncology, National Taiwan University Hospital. Clinical Associate Professor, Graduate Institute of Oncology, National Taiwan University College of Medicine. ) - 2012. J. Jack Lee, Ph.D.. Department of Biostatistics. University of Texas . M. D. Anderson Cancer Center. How many patients are needed in a clinical trial?. It depends on what you want to achieve.. Christopher S. Coffey. Professor, Department of Biostatistics. Director, Clinical Trials Statistical and Data Management Center. University of Iowa. May 28, 2019. In this webinar, we will:. Discuss the importance of adequate study planning for small clinical trials. artbin. ). Ella Marley-Zagar, Ian . White. , . Mahesh . Parmar, Patrick Royston, . Abdel Babiker. e.marley-zagar@ucl.ac.uk. MRC Clinical Trials Unit at UCL. “London” Stata Conference. 9. . September . Alternative Study Designs and Randomization Schemes. Demonstrated on . Paul Murphy. nQuery Research Statistician. Webinar host. Host. AGENDA. 1) . Background. 2) Crossover Trials. 3) Cluster Randomized Trials. & . specificities. for epidemic diseases in LMICs. P. . . Olliaro. WHO/TDR & . University of Oxford. Regulatory. Clinical studies. (Phase I, II, III). First In . Humans. Discovery. & Pre-clinical. Design and Endpoint Considerations. Demonstrated on . Head of Statistics. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. AGENDA. Introduction to Non-inferiority Testing. Munya Dimairo. Research Fellow in Medical Statistics. University of Sheffield, UK. m.dimairo@sheffield.ac.uk. . / . mdimairo@gmail.com. . Twitter: @. mdimairo. CREDO Ethiopia 12-13 July 2017. Declarations. What you should know about study design. Demonstrated on . Head of Statistics. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. AGENDA. Adaptive Designs in Confirmatory Trials. Primer on Sequential Design Methods . and Design Choices. Ronan Fitzpatrick. Lead Statistician. nQuery. Webinar. Host. Agenda. Sequential Design Overview. Issues in Sequential Design. Group Sequential Design. Brad Rechtzigel Kohei Osterloth. "The gold standard for evaluating a new intervention" . -Allen Hackshaw. Main topics. What is Phase III?. What are the objectives?. What are the outcomes? . How large should the sample sizes be ?. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Introduction to Adaptiv. e Design. Adaptive Design Regulatory Context. Sample Size Re-estimation & Worked Example. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Adaptive Designs and Sample Size Re-estimation (SSR). Blinded Sample Size Re-estimation .