May 17th, 2024 3:00-4:00PM EDT/12:00-1:00PM PDT
Understanding the Big Picture as a Statistician in Pharmaceutical Industry
Clinical Development Plan
Speaker: Dr. Naitee Ting
Abstract: Most drugs start out as a simple chemical compound. Chemists and biologists study a certain disease process, and synthesize many compounds in the laboratory with the hope that some of these compounds can help patients with this disease. If a compound demonstrates good efficacy and low toxicity, this compound will progress into animal testing (non-clinical studies) and human testing (clinical studies). Clinical trials are broadly divided into 4 Phases – Phases I, II, III, and IV. A clinical development plan starts with a draft drug label, known as the target product profile (TPP). Each phase of clinical development is planned according to this TPP. In this presentation, we will discuss how statistical thinking is applied in supporting the CDP.
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This webinar is sponsored by the ICSA. Interested in viewing past webinars or learning more about the ICSA webinar series? Please visit the ICSA website for more information: Past Webinars – International Chinese Statistical Association (icsa.org)