ABSTRACT
Preformulation is usually defined as the science of the physicochemical characterization of candidate drugs. However, any studies carried out to define the conditions under which the candidate drug should be formulated can also be termed preformulation. This is a broader definition than was used in Chapter 3, and, as such, it can include studies on preliminary formulations under a variety of conditions. These studies may influence the Product Design and should be conducted at the earliest opportunity at the start of development. In the interest of faster drug development and reduced drug usage, preformulation studies should not be undertaken on a “check-list” basis. Rather, they should be conducted on a need-to-know basis.
