Tag: Simcyp
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking
This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple sclerosis and spinal injury. Tizanidine is primarily metabolized by CYP1A2 and is considered a sensitive … Continued
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of modeling & simulation software for regulatory purposes. Concepts of quality, data reproducibility, model qualification (model … Continued
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage of new drug approvals including PBPK analyses in 2019 [1]. Another paper showed a rise of more than 280% in pharmaceutical applications of PBPK M&S … Continued
PBPK modeling approaches to assess risks associated with bioequivalence in drug development
In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalence IVIVE-PBPK in biopharmaceutics An quantitative risk assessment approach for virtual bioequivalence Role of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence
