The Evolution of Model-informed Precision Dosing through Co-developed Companion Tools
Co-developing Model-informed Precision Dosing companion tools accelerates generating the evidence needed to broadly implement MIPD in the clinic.
Month: September 2019
FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology
Health Canada PRCI Guiding Principles and Observations
Health Canada released guidance on 3월 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to … Continued
Summary of Health Canada’s Public Release of Clinical Information Initiative
Health Canada released guidance on 3월 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to … Continued
How Model-Based Meta-Analysis Leverages Public Data to Support Strategic Drug Development Decision Making
Model-based meta-analysis (MBMA) helps sponsors to make the wisest, most informed decisions about the next steps in their drug’s development and market positioning.
Building an Early Development Strategy for Complex Biologics
This blog described some important strategic considerations for successful development of complex biologics.
Certara Launches Version 8.2 of its Industry-leading Phoenix PK/PD Modeling and Simulation Software for Drug Development
Aligned with newly issued FDA Draft Guidance, Phoenix supports electronic data, methods and results audit, traceability and communication requirements.
