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Application of IVIVC and PopPK for your regulatory submissions
Tue, November 09th
オンデマンド・ウェビナー

Tue, November 9th, 9:30 am – 11:30 am CST (China Standard Time)

In the webinar, we will introduce IVIVC and NLME modules of the Phoenix platform with real-life examples to show why these tools are widely used. We will invite a guest speaker to share the latest advances in PopPK research. During our webinar, you will have the opportunity to interact with the speaker online, and we will answer your questions.

IVIVC:

In Vitro In Vivo Correlation (IVIVC) is a predictive mathematical tool that describes the relationship between the in vitro properties of a drug dosage form and the in vivo pharmacokinetic (PK) response. The EMA, PMDA, US FDA and other regulatory agencies have encouraged relevant agencies to develop IVIVC models for solid dosage forms, particularly for extended-release formulations. This tool can help support bioequivalence exemptions and has become an alternative to in vivo human bioequivalence (BE) studies.

NLME:

Phoenix NLME is the most powerful nonlinear mixed-effects modeling engine designed for quantitative pharmacology, a groundbreaking product that has changed the learning curve in the discipline of population pharmacokinetics (Pop PK) and is widely used by regulatory agencies, including the US FDA.

**The webinar will be presented in English and Chinese.

Speakers

Chris Mehl, Associate Director, Pharmacokinetics Software, Certara
Marco Ding, Director of Business Development, Certara China
Guest speakers’ information is available on the registration page

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