More than 50 bispecific antibodies are in oncology clinical development with a large diversity in formats, directed at a range of immune and tumor targets. Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are complex modalities with challenges to overcome in early clinical trials, including selection of relevant starting … Continued
Most drug labels do not provide dosing guidance for pregnant and lactating women, yet in the U.S. alone, more than 6 million women are pregnant each year, and it is estimated that more than 90 percent take at least one medication while pregnant or lactating. Simcyp has developed and published papers on its time varying … Continued
By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.
By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics. Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued
Patients often take more than one drug at a time, especially elderly patients and those with complex diseases, such as cancer and neurological disorders. Therefore, it is crucial to determine what the potential risk might be of a new drug candidate interacting with existing marketed medications. …
