| Call Number | 15978 |
|---|---|
| Day & Time Location |
T 2:30pm-5:20pm LL108A/B Armand Hammer Health Sciences Center |
| Points | 3 |
| Grading Mode | Standard |
| Approvals Required | None |
| Instructor | Naitee Ting |
| Type | LECTURE |
| Method of Instruction | In-Person |
| Course Description | The drug development from compound discovery to marketing and commercialization registration is a lengthy and complex process in which statisticians play an important role from the beginning to the end. The main objective of this course is to provide students with working knowledge of methodological and operational issues that arise in different stages of the drug development that involve statistical contributions. Topics include: Introduction of drug development; design and analysis of non-clinical studies (toxicology, pharmacokinetics and pharmacodynamics) and Phase I/II/III studies; issues in clinical studies including non-inferiority, meta-analysis, and endpoint selection; overview of safety reporting systems such as MedDRA (Medical Dictionary for Regulatory Activities), CTC version 3 (Common Terminology Criteria for Adverse Events), and preparation for the FDA advisory committee drug approval process. In addition, the views and positions of different regulatory bodies, such as the FDA or EMEA, on design and analysis issues will be discussed. |
| Web Site | Vergil |
| Department | Biostatistics |
| Enrollment | 36 students (40 max) as of 11:36PM Thursday, March 13, 2025 |
| Subject | Biostatistics |
| Number | P8144 |
| Section | 001 |
| Division | School of Public Health |
| Open To | GSAS, Public Health |
| Section key | 20251BIST8144P001 |