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BIOF 084 | Pharmacometric Dose-Response Analyses in Clinical Trials Using R
July 13 @ 9:00 AM – July 16 @ 4:00 PM
In order for a drug to get approved by the FDA for market in the USA, the sponsor must ultimately demonstrate the drug has: 1) a predictable exposure profile with dose, 2) a good safety profile, and 3) is effective at safe doses.
Participants will learn basic pharmacology theory with introductory statistics using a popular open source software program (R Studio) that is capable of conducting pharmacokinetic (PK) exposure and pharmacodynamic (PD) response analyses from example clinical trial data. Ultimately, the framework of analyzing exposure/response relationships will be demonstrated in order to make go/no go decisions.
1. Introduction to a broad range of pharmacology topics
2. Introduction to a basic level of statistical analyses for clinical trial data
3. Introduction to the basics of computer coding necessary for R Studio
4. Framework of analyses laid for post-course continuing education