It is a well-established principal that even the most promising API, monoclonal antibody ortherapeutic peptide can only be turned into an effective and marketable drug if formulated in such a way that it reaches the blood stream and is bioavailable.
But, while this characteristic – bioavailability – has been the focus of lab scientists, clinical researchers and process developers’ efforts for many years, finding the solution that gives a particular drug the desired profile is still a major headache for pharmaceutical firms.
And such difficulties are likely to become a common experience for teams developing new drugs as – increasingly – pharmaceutical company pipelines fill with candidates based onbiopharmaceutics classification system (BCS) class II and IV compounds.
However, these difficulties are not limited to firms developing new drugs as generic drugmakers also face their own bioavailability challenges. Strict regulatory requirements onbioequivalence testing mean more trials, more analysis and more formulation development work, all of which increase cost and length of time it takes to bring a non-branded product to market.
Similarly, biopharmaceutical firms hoping to develop oral delivery alternatives for injectable biologics will also need to work out how to ensure that their products are bioavailable, safe and effective.
Who should attend?
Our online event will be a forum for regulators, academics and research scientists to discuss the development bottlenecks, identify market opportunities and share the innovations that are helping the pharmaceutical industry overcome the Bioavailability Challenge.