It is well known that traditional drug product optimization processes take significant time.
Great emphasis is placed on laboratory and preclinical assessments to identify human formulations. Even though data do not adequately capture the performance of the dosage form in vivo, and the translation from the preclinical species to humans is suboptimal, drug developers often invest a significant amount of time and resources at this stage.
There is a critical need to rapidly enter clinical testing of new chemical entities (NCEs) in humans, assess their performance, and optimize as needed.
What is Translational Pharmaceutics®?
Translational Pharmaceutics® is an integrated approach to drug development. It is an innovative platform proven to shorten development timelines by 12 months or more. First applied in 2008, the platform uses clinical data to improve decision-making and halve development timelines.
How is Translational Pharmaceutics® used?
Quotient Sciences Translational Pharmaceutics® is a powerful solution to address the challenges of drug product optimization, in particular, which is one main application.
In a recent client example, we supported the development of an extended-release drug product for overdose protection of a prescription drug. It was a complex program using a prodrug that requires activation by trypsin in the gastrointestinal tract and an inhibitor that requires delivery over an extended duration due to its short duration of action. We were able to help the customer adjust the release rate and dose for the immediate and extended-release beads across a two-part clinical study to support our client in meeting their goals. This was done using the concept of a "design space" to test ranges of doses and other critical to performance parameters in a clinical program.
Video: Our expert discusses applying Translational Pharmaceutics® to drug development
Translational Pharmaceutics® has been successfully applied to over 300 drug product optimization programs, delivering significant benefits in areas including solubility enhancement and modified release drug development activities.
In this video, watch Aruna Railkar, Senior Drug Development Consultant, speak on this topic at the 2024 Controlled & Modified Drug Release Summit in New Jersey about how we apply Translational Pharmaceutics® to drug product optimization.
Want to discuss your next program and how we might be able to help? Contact us today.