Objectives: Health outcomes modelling, conventionally used in health technology assessment, is based on disease progression models with the probabilities of…
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Regulatory model-informed drug discovery and development in EU – News flash and examples
Objectives: To provide an update on modelling and simulation involvement in the EU regulatory activities and procedures and highlight the…
Read moreRegulatory pharmacometrics in the EU in practice and the role of the Modelling and Simulation Working Group
Objectives: To give an overview of regulatory pharmacometrics within the European Union aiming for a smoother workflow between regulators and…
Read moreGood Practices in Model Informed Drug Discovery and Development (MID3): Practice, Application, Documentation and Reporting
Objectives: The workgroup evolved from the original 2011 EFPIA /EMA M&S workshop committee. The aim was to continue a dialogue…
Read moreLaunch of the new journal ‘CPT: Pharmacometrics & Systems Pharmacology’
The American Society for Clinical Pharmacology and Therapeutics (ASCPT) and Nature Publishing Group are pleased to announce the upcoming launch…
Read moreAnnouncement of WCoP 2016
Invitation to attend From WCoP Executive Committee and the WCoP 2016 Organizing Committee On behalf of the WCoP 2016 organizing committee,…
Read morePMX perspective on Estimands
The concept of estimands in clinical drug development has re-emerged with the publication of the draft ICH E9 addendum. The…
Read morePresentation of DDMoRe
Model based-drug development (MBDD) is accepted as a vital approach in understanding patient risk/benefit and attrition. At the core of…
Read moreExtrapolation of a Brivaracetam Exposure-Response Model from Adults to Children
Objectives: To scale an existing adult population PK/PD model for brivaracetam (BRV) into children, using a combined adult-pediatric PK/PD model…
Read morePhysiologically-Based Predictions of Monoclonal Antibody Pharmacokinetics: Insights from a Large-Scale Data Analysis
Background Monoclonal antibodies (mAbs) have become a cornerstone of oncology and immunology therapies, traditionally administered intravenously over extended treatment periods,…
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