Are You Setting Your Molecule Up for Clinical Success? How to Efficiently Bridge from First-in-Human Formulations to Scalable Dosage Forms for Proof-of-Concept Patient Trials
Cost, time, quality and dose flexibility are key considerations when developing first-in-human (FIH) dosage forms. Very often a simple pharmacy preparation may be sufficient to meet the requirements for Phase I clinical studies, but such products are likely to be unsuitable for Phase II patient trials which may take place at multiple clinical sites, in different countries and extend over a long period of time. Costly delays and budget overruns during product development and scale up can be prevented by carefully planning and integrating development activities and technology consideration from the outset. How do you develop a formulation that will be suitable for preclinical and FIH testing? How can you bridge from pharmacy preparations to GMP solid oral dosage forms that will be robust and scalable? How can you avoid common development pitfalls and ensure future success?
Quotient Sciences and Catalent Pharma Solutions, two leading drug development and manufacturing organizations, are coming together to share their expertise on phase appropriate formulation strategies and selecting the best technologies that will successfully transition your molecule into FIH clinical trials and then on through to your POC milestone and beyond.
Key considerations and strategies that will be covered include:
- Strategies on how to develop a phase-appropriate formulation
- Bridging drug products from preclinical to first-in-human and scaling for your POC trials
- Integrating pharmaceutical sciences & clinical testing to accelerate drug product development and reduces costs
- Assessing the challenges of poorly soluble molecules in early development and what technologies are best suited to enhance bioavailability
- Selecting scalable technologies to support your drug product’s needs and understanding the pros and cons