Over the past two decades, there have been transformative changes in our approach to using modelling & simulation (M&S) to assess and manage drug–drug interactions (DDIs) involving CYP enzymes and…
Join us on November 10th for this webcast being held in partnership with RAPS. The Clinical Trials Regulation (CTR) for the European Union (EU) took effect on January 31, 2022….
Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage the disease modulating proteins directly but instead target their encoding mRNA (read more about how…
PRINCETON, N.J.— October 12, 2022 – Certara, Inc., a global leader in drug development software, today announced the release of the PK Submit™ 2.0. The software allows scientists to automatically…
Gain a foundational understanding of QSP in this 101-level article with examples of QSP applied to Immunogenicity, Immuno-Oncology, and other areas.
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some…
For the first time, the European Medicines Agency (EMA) has passed new regulations to help patients understand the results of clinical trials of investigational drugs that they volunteer for. Known…
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive 2001/20/EC), drug developers must now anonymize or redact clinical trial documents at the same time…
Properly understanding the probability of successful drug development requires utilization of all available information. Critical drug development decisions cannot be made with internal data alone. Model-based meta-analysis (MBMA) extracts important…
In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects…
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