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Create PK CDISC Domains in Minutes Using PK Submit™️

In this 30-minute webinar, you will learn about PK Submit, a new add-on to Phoenix WinNonlin that automates the creation of PK CDISC domains during NCA analysis.  It can generate both Study Data Tabulation Model (SDTM) and Standard for Exchange of Nonclinical Data (SEND) datasets.  PK Submit was designed to create the entire PK regulatory […]

Speaker(s): Kevin Trimm
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Building an MBMA Framework to Support Developing New Neuropathic Pain Drugs

In this webinar, Leticia Arrington (Merck) and Richard Franzese (Certara) discussed data considerations, analysis methods, and learnings from a recent network MBMA analysis of relevant endpoints in NP that will be used for general competitive landscaping questions to support Merck’s ongoing mission to develop better NP therapies.

Speaker(s): Leticia Arrington, Richard C. Franzese
Solution: Model-based Meta-analysis, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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Found in Translation: Building an Early Development Strategy for Complex Biologics

This webinar described some important strategic considerations for successful development of complex biologics including appropriate data collection and timings, analyses requiring cross-functional data integration, and key pharmacology-related critical questions.

Speaker(s): Aaron Moss, Christina Mayer
Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology, Rare/Orphan Disease
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