The Pharmacokinetics (PK) of ADC therapeutics typically show a discrepancy between the PK of total antibody and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms may be more complex. In this webinar, we will present how quantitative systems … Continued
For pharmaceutical companies, agencies play a crucial role in creating interactive content that effectively communicates product value to payers. However, in times of shrinking budgets, it becomes even more essential to ensure efficient collaborations with agencies to achieve optimal results. Traditional workflows often face challenges due to agency dependence, lengthy development cycles, and obstacles in … Continued
Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end? A retrospective … Continued
Scientists in drug discovery often spend excessive time managing research data instead of concentrating on identifying the most promising compounds for new drugs. The right technology streamlines the drug discovery process, providing a seamless workflow for data-driven design, analysis, and research tracking of small molecules. In this webinar, experts from Certara and Chemaxon will guide … Continued
The eCTD v4.0 standard introduces several changes to the submission process, including updated granularity, context groups, re-used files, and more. The change will require new habits and new technology, but one upside is better harmonization across regulatory agencies. Join our webinar to discuss some of the nuanced changes in the v4.0 standard and discover how … Continued
Various methods exist to calculate the absorption profile. In this webinar, Dr. JM Cardot will explore the various methods while highlighting the advantages and drawbacks of each of them along with the prerequisites. It will also explore the risks of using already available data in combination with newly obtained data in a new group of … Continued
新薬臨床試験申請開始（IND）のプロセスや方法を選択する際、予算、ソフトウェア、人的サポートなど、決定しなければならない多くの要素があります。budget, software, personnel support, and more. To further complicate matters, these components must come together in harmony to ensure a smooth filing. Instead of concentrating individual efforts on research and how to unify the process, … Continued
