The European Medicines Agency (EMA) Policy 0070 requires disclosing clinical trial results. Its mandate is to build public trust and enhance transparency in pharmaceutical clinical trials. In 2018, EMA suspended this policy following Brexit. The suspension remained throughout the COVID-19 pandemic, except for exceptional transparency measures for COVID-19 medicines. In 2023, EMA restarted Policy 0070 … Continued
The Kraków HTA Symposium brings together a diverse group of healthcare stakeholders from across Europe to share their perspectives and explore collaborative opportunities. Past attendees have included representatives from the Ministry of Health, Polish HTA Agency, hospitals, academia, pharmaceutical and medical device manufacturers, and other key players in healthcare. Location: Manggha Museum of Japanese Art … Continued
Medical writing is evolving, and cutting-edge technology is leading the way. Join us for an insightful discussion on how automation is transforming patient narrative writing—saving time, reducing complexity, and enhancing accuracy. This webinar will explore how the appropriate use of technology can streamline the creation of patient narratives. We’ll also showcase real-world applications through an … Continued
Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety. Predicting immunogenicity is complex because of its multifactorial drivers, including compound properties, subject characteristics, and treatment parameters. To integrate these, the Immunogenicity Simulator was developed using published, predominantly late-stage trial data from 15 therapeutic proteins. This single-blinded … Continued
Data standardization is the key to faster, more accurate analysis, resulting in successful submissions. By applying standards at the point of collection, you save time and reduce the risk of manual errors as you approach interim analyses, prepare regulatory documents, or simply make “no/no-go decisions” based on early results. But if standardization is the key … Continued
A key drug development safety consideration is whether the drug candidate will interact with co-medications. Drug-drug interaction (DDI) studies are used to help assess this risk. These studies quantify the impact of the drug candidate on key drug-metabolizing enzymes. The most studied metabolic enzymes are the cytochrome P450 (CYP) enzyme family members. Recommended index substrates … Continued
What kind of model will strike the best balance of fit and parsimony for your PK data? A one compartment? Two or three? What about elimination? Is it linear, Michaelis-Menten, or TMDD? These are just two of the many structural considerations you face when building a popPK model. While known drug and subject characteristics may … Continued
Join us for an exclusive webinar led by Simcyp’s world-class experts to explore the newest developments in the Simcyp Simulator, the gold standard in physiologically based pharmacokinetic (PBPK) modeling. With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate its capabilities. The latest features in Version 24 include: Don’t miss … Continued
This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2 inhibitor, across multiple cancer types, including relapsed and refractory (R/R) myelofibrosis (MF), Merkel cell carcinoma (MCC), and other malignancies. Using a PK model based on 318 subjects, researchers found that tumor type influenced navtemadlin’s absorption, clearance, and exposure, with factors … Continued
