'Confirmatory studies' presentation slideshows

PDI Data Literacy: Busting Myths of Big Data

PDI Data Literacy: Busting Myths of Big Data. Nairanjana (Jan) Dasgupta Professor, Dept. of Math and Stats Boeing Distinguished Professor of Math and Science Director, Center of Interdisciplinary Statistics Education and Research (CISER) Washington State University, Pullman, WA

1.56k views • 154 slides

PDI Data Literacy: Busting Myths of Big Data

PDI Data Literacy: Busting Myths of Big Data. Nairanjana (Jan) Dasgupta Professor, Dept. of Math and Stats Boeing Distinguished Professor of Math and Science Director, Center of Interdisciplinary Statistics Education and Research (CISER) Washington State University, Pullman, WA

1.55k views • 154 slides

Endpoints for Past Approvals

Endpoints for Past Approvals. Ramzi Dagher DODP/CDER/FDA. Endpoints in Oncology. Survival (gold standard) TTP (advantages and challenges) DFS (adjuvant setting) ORR (treatment responsible for tumor reduction) Tumor related symptoms/PRO. Clinical Benefit Endpoints : Regular Approval.

273 views • 13 slides

Rare Disease Workshop 5: Post Marketing Confirmatory Studies in Rare Diseases

230 views • 8 slides