Mass Transport Modelling in support of leachable risk management

Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products.

As healthcare organizations are becoming more adept at developing models, the ability and required skills to manage, validate, and deploy those models efficiently remain a challenging task. This webinar will present an overview and history of this process, along with tools and techniques that can help your organization to more effectively operationalize models.

After the US Food and Drug Administration (FDA)’s stated that “the clinical trial system is broken,” regulatory agencies began working to formally figure out how real-world evidence will be used in new drug submissions and for new uses of existing drugs. The business potential is huge: organizations can reduce the time and cost of bringing new drugs to market by relying on existing real-world data and new sources of unstructured data, e.g., EHRs and social media. Most importantly, this real-world data can get patient-saving drugs to market more quickly with fewer post-release adverse events.

Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications. They are made of a highly toxic payload, a linker, and an antibody.