Formulation is a critical part of the drug development process and encompasses a wide range of activities including developability and buffer screening, as well as dosage studies and compatibility with the required storage container or administration device. Early investment into the optimal form of the drug candidate as part of a developability program pays dividends in the long run. This program can provide multiple readouts to help mitigate risk and capture the fundamental characteristics of successful drug design: specificity, functionality/potency, safety, pharmacokinetics, and manufacturability.
Providing this information on the risks and liabilities early will increase the chances of meeting the requirements of the target product profile (TPP) and allow for modifications to the design prior to entering the more expensive stages of drug development. This webinar recording provides an overview of how formulation development fits into the development of drugs. We demonstrate the importance of de-risking drug candidates with data generated to support lead candidate selection – an overview of the processes involved in formulation are included. Watch this webinar for a summary of how to create a phase-appropriate de-risking strategy to develop and apply suitable formulation processes to align with the optimal target product profile.
The expert speaker discusses the different approaches that can be applied to different stages of the drug development process, including:
· Emphasis on early investment to de-risk candidates
· Obtaining early-stage stability data to support faster filing times
· Selection of an appropriate formulation strategy depending on the stage of development
Catch up on this webinar to learn more about the applications of formulation development in drug developability and hear about case
studies which illustrate the approaches used to overcome challenges in their design and testing.