Gaining a thorough understanding of the chemical and pharmacological attributes of a drug substance through preclinical studies is paramount for providing effective dosage form and amount for first-in-human clinical trials. Yet often insufficient consideration is given to ‘knowing the compound’ and as such, many compounds fail due to a lack of efficacy and an inadequate safety profile, both of which have a drug exposure consequence.
XenoGesis works with clients to understand and determine dose prediction at an early stage.
Failure to predict the PK and dose early on results in the following:
- The compound or series may be fatally flawed
- Poor bioavailability will not allow toxicology studies to be conducted
- The outcome of any clinical trial may be compromised
- Dosing not commensurate with once-a-day dosing
To find out how XenoGesis can work with you on early dose prediction, contact the team. For more information, read Dr Richard Weaver’s article published in the European Biopharmaceutical Review, here.