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Simcyp In Vitro Analysis (SIVA) Toolkit: Get the Most from Your In Vitro Data

20160414
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Analysis of in vitro data from whole cell systems and dissolution studies is complex, challenging and time consuming. Yet accurate data analysis and informed data interpretation early in drug development is crucial. Existing tools have mainly been developed for broader data analysis and are not specifically designed for in vitro systems. These software tools do not readily support analysis of complex in vitro data, which is key to successfully predicting in vivo behavior with physiologically based pharmacokinetic (PBPK) models and informing critical decisions.

The SIVA Toolkit is a user-friendly platform, specifically designed to assist scientists with analyzing complex in vitro studies. This innovative solution can analyze a broad range of in vitro assays― whole cells, tissue samples and solid dosage forms― to assess the metabolism, transport and dissolution/solubility of drugs. In this webinar, Nikunjkumar Patel and Howard Burt presented several case studies that illustrate how SIVA can help you get the most out of your in vitro data!

講師紹介

Nikunjkumar Patel, Senior research scientist, Certara. Nikunj Patel is a senior research scientist in Certara’s modelling and simulations group where he is leading oral and dermal absorption projects and is a member of the Cardiac Safety Simulator development team. He joined Certara in August 2011 and led the development of the physiologically based IVIVC (PB-IVIVC) module of the Simcyp Simulator and the Pharmaceutics module of SIVA (Simcyp In Vitro (data) Analysis) platform. Before joining Certara, he spent three years at the life science innovation labs of Tata Consultancy Services as a research scientist mainly working on pharmacokinetic/pharmacodynamic modelling and QSAR development for various ADMET properties. During his graduate studies, he used computer aided drug design (CADD) and molecular modelling to identify safe and potent novel anti-diabetic ligands.

Howard Burt, Senior Research Scientist, Certara. Dr. Howard Burt is a Senior Research Scientist at Certara where he currently leads the development of the Simcyp in vitro analysis (SIVA) toolkit. He obtained his Ph.D. and postdoctoral experience from the Centre of Applied Pharmacokinetic Research at The University of Manchester, focusing on the prediction of clinical DDIs arising from time-dependent enzyme inhibition (TDI) using in vitro data. He has worked within DMPK departments at both Pfizer (Sandwich, UK) and Merck Serono (Geneva, CH). Since joining Simcyp in 2011 he has been involved in the development of the permeability-limited kidney (Mech KiM) and liver (PerL) models within the Simulator in addition to several consultancy projects. He has also been involved in the development of models for time-dependent enzyme inhibition in the gut and nonlinear plasma protein binding and blood-to-plasma ratio.

Analysis of in vitro data from whole cell systems and dissolution studies is complex, challenging and time consuming. Yet accurate data analysis and informed data interpretation early in drug development is crucial. Existing tools have mainly been developed for broader data analysis and are not specifically designed for in vitro systems. These software tools do not readily support analysis of complex in vitro data, which is key to successfully predicting in vivo behavior with physiologically based pharmacokinetic (PBPK) models and informing critical decisions.

The SIVA Toolkit is a user-friendly platform, specifically designed to assist scientists with analyzing complex in vitro studies. This innovative solution can analyze a broad range of in vitro assays― whole cells, tissue samples and solid dosage forms― to assess the metabolism, transport and dissolution/solubility of drugs. In this webinar, Nikunjkumar Patel and Howard Burt presented several case studies that illustrate how SIVA can help you get the most out of your in vitro data!

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