Utilizing a data-driven approach during candidate selection is key when trying to develop dosage forms and achieve proof-of-concept success.
By applying key strategies in early development such as salt and polymorph screening to select the right API form, pre-formulation characterisation to understand the API, development and assessment of preclinical formulations and screening of technologies for dealing with poorly soluble molecules, you are able to gain a complete understanding of your molecule prior to the first-in-human (FIH) clinical study.
This data can then be matched against your target product profile and clinical requirements to effectively guide dosage form development and selection to effectively and efficiently begin FIH testing and then quickly transition through to proof-of-concept (POC) patient trials.
This webinar will explore screening techniques, integrated approaches and phase-appropriate product development strategies.
Good science, quality, cost and time are important considerations for drug developers and we will address some key questions:
- What is a suitable screening package for determining the physical properties of an API and what are the red-flags to watch out for?
- How can the developability classification system (DCS) be used to streamline my formulation development program?
- How will in-vitro testing and preclinical evaluation help me guide the clinical formulation?
- Will a preclinical formulation be suitable for clinical use?
- Could a simple pharmacy preparation be suitable for my FIH trial or will a manufactured dosage form be required?
- How can we 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?