Gaining a thorough understanding of the chemical and pharmacological attributes of a drug substance through preclinical studies is paramount for providing an effective dosage form for first-in-human clinical trials. Yet often insufficient consideration is given to ‘knowing the compound’ before selecting a presentation for clinical evaluation. In particular, an accurate prediction of an appropriate dose range is vitally important for adopting the most appropriate formulation strategy for the compound. If the formulation is not suitable to deliver the required quantity of the drug then the outcome of the clinical trial may be compromised.
Juniper Pharma Services and XenoGesis work together successfully to provide an integrated biopharmaceutics service offering. The unique combined approach helps to remove the gap between ‘chemical’ and ‘biological’ to provide the most effective drug delivery solutions.
Richard Weaver joins Rob Harris to provide an insight into how our joint, consultative approach to drug development can help in understanding the absorption and clearance characteristics of a drug substance and how these properties will influence dose prediction and selection of an appropriate formulation strategy.
Registration from 11.00am with lunch at 12.00pm.