Introduction to typical pharmaceutical development activities and timeframes for toxicological studies.
Making the first 100g non-GMP batch for GLP toxicological studies; discussion of topics such as setting the specification, the use of chromatography, accessing starting materials, identifying how much development to do.
Non-GMP vs GMP preparation. A brief introduction to GMPs and how they impact on the initial chemistry scaling exercise.
Physical version and form, spending time on the importance of salt selection, especially in the early phases of development with form/polymorph considerations also being discussed. There will be a brief introduction of polymorphism and which aspects of physical form should ideally be established at the early phase of development.
Process safety and raw materials supply issues and how these might impact on the chosen route.
Review of the day and questions.