DMPK - A Key Step, Every Step of the Way Drug metabolism and pharmacokinetics (DMPK) is a crucial component in the success of your drug development – at every stage, from discovery to preclinical to clinical. DMPK studies set basic expectations of drug behavior, which...
Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...
Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...
In vivo studies, such as pharmacokinetics (PK) and absorption, distribution, metabolism and excretion (ADME), are critical to your compound’s vitality as you prepare for regulatory submission. Knowing when these studies should be completed can often be a pressure...
Immunogenicity assessment helps drug developers understand the possible immune responses that can occur when humans are exposed to a potential therapeutic protein. Recently, the FDA has updated its guidance for immunogenicity risk assessment for developing and...
In 2019, the U.S. Food and Drug Administration (FDA) revised its guidance for immunogenicity risk assessment (IRA) of biological therapies. IRA is required to help drug developers and regulatory agencies better understand the potential impact an immune response will...
For drug developers ready to progress a molecule to the pivotal clinical trial stage, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) is a significant milestone. Drug developers approach this task with a wide range...
The recently updated guidelines on assessing drug-drug interactions will likely improve experimental outcomes, reduce costs and streamline development timelines. The U.S. FDA updated its guidelines for in vitro drug interaction assessment to help drug developers...
The novel coronavirus (COVID-19) pandemic has thrown many standard procedures out the window, including how companies approach the logistics of shipping biological samples to China. To prevent the introduction and spread of infectious disease, Chinese Customs...
As our partners’ research and development programs begin to ramp up, so does the need for additional resources. At WuXi AppTec, we remain committed to ensuring the availability and integrity of the research models used on our customers’ vital development programs is...
As your partner we are taking all the necessary steps to make sure your drug development continues without any disruptions in the process. Moving your molecule forward during COVID-19 doesn’t need to be stressful or difficult. We continue to learn and have found...
Meeting drug development timelines are highly important and the building blocks of success for drug development companies. Frequently, financing tranches are connected to the achievement of milestones, and potential strategic partners may be evaluating multiple...