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BIOF 084 | Pharmacometric Dose-Response Analyses in Clinical Trials Using R

October 6 @ 9:00 AM October 8 @ 5:00 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. Therefore, the pharmacology of a drug is essentially being reviewed by the FDA. The ability of scientists to analyze drug exposure/response relationships is crucial to understanding what exposure amount will elicit the safest, most effective response, and ultimately what dose amount and frequency will produce the optimal exposure amount. Additionally, the ability to identify sub-populations that may produce differing exposure or response levels is key to providing as many subjects as possible a safe and effective dose. This quantitative exposure/response analyses, often referred to pharmacometrics, is key to making go/no go decisions both during clinical trials by investigators, and the FDA during the subsequent review period.