> Pre-formulation development: physical and chemical characteristics of the proposed active ingredients are analyzed to allow selection of optimal excipients and dosage forms.

> Formulation design: based on the product's organoleptic and physicochemical characteristics, a range of theoretical formulations is proposed to determine how they may influence the final product's characteristics such as the in vitro/in vivo performance and stability.

> Compatibility tests: If necessary a differential scanning calorimetry (DSC) study is usually conducted to determine active ingredients/excipient compatibility.

> Prototype development: APR's contract development team develops a prototype in the laboratory using data from formulation development/design and compatibility tests. Generally, only minor modifications to the prototype are required when the process is scaled up to large-scale manufacturing.

> Preliminary stability studies: using International Conference on Harmonization (ICH) guidelines, the prototype is tested to determine if the selected formulation(s) can be considered stable . The exact nature of tests carried out depends on the product and individual customer requests.