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The top documents tagged [critical path initiative]

The A to Z of pharmaceutical cocrystals: a decade of fast-moving new science and patents
The A to Z of pharmaceutical cocrystals: a decade of fast-moving new science and patents
6.303 views
FDA/Industry Workshop September 14-16, 2005 Critical Path Initiative: What it means for pharmaceutical industry statisticians Walter Offen, Lilly Brenda
FDA/Industry Workshop September 14-16, 2005 Critical Path Initiative: What it means for pharmaceutical industry statisticians Walter Offen, Lilly Brenda
223 views
An Update on FDAs Critical Path Initiative Statistical Contributions Robert T. ONeill Ph.D. Director, Office of Biostatistics Center for Drug Evaluation
An Update on FDAs Critical Path Initiative Statistical Contributions Robert T. ONeill Ph.D. Director, Office of Biostatistics Center for Drug Evaluation
217 views
Evaluating the value of research-by-consortium: Science of Team Science
Evaluating the value of research-by-consortium: Science of Team Science
146 views
PGx Testing
PGx Testing
45 views
1 Overview of Pharmaceutical Technology and Education Areas: Industrialization Pharmaceutical Technology Manufacturing Science Pharmaceutical Engineering
1 Overview of Pharmaceutical Technology and Education Areas: Industrialization Pharmaceutical Technology Manufacturing Science Pharmaceutical Engineering
243 views
Cellular Tissue and Gene Therapies Research Site Visit Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies September 29,
Cellular Tissue and Gene Therapies Research Site Visit Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies September 29,
225 views
1 The ACTION Public-Private Partnership: Background, Rationale, and Objectives Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia, and Addiction
1 The ACTION Public-Private Partnership: Background, Rationale, and Objectives Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia, and Addiction
215 views
Oncology Dose Finding A Case Study: Intra-patient Dose Escalation Jonas Wiedemann, Meghna Kamath Samant & Dominik Heinzmann, pRED Biostatistics, Valerie
Oncology Dose Finding A Case Study: Intra-patient Dose Escalation Jonas Wiedemann, Meghna Kamath Samant & Dominik Heinzmann, pRED Biostatistics, Valerie
233 views
The Critical Path Opportunities for Efficiency in Development Robert J. Temple, M.D. Associate Director for Medical Policy Center for Drug Evaluation and
The Critical Path Opportunities for Efficiency in Development Robert J. Temple, M.D. Associate Director for Medical Policy Center for Drug Evaluation and
221 views
Use of Biomarker Information in Drug Product Labels to Individualize Pharmacotherapy Lawrence J. Lesko, Ph.D., FCP Director of the Office of Clinical Pharmacology
Use of Biomarker Information in Drug Product Labels to Individualize Pharmacotherapy Lawrence J. Lesko, Ph.D., FCP Director of the Office of Clinical Pharmacology
217 views