This subject extends the principles covered in Pharmaceutical Development of Medicines and includes detailed treatment of the formulation and in vitro/in vivo assessment of oral controlled-release products and novel dosage forms such as transdermal therapeutic systems and osmotic pumps. There is an extensive chapter on the formulation and testing of inhalation products, including metered dose inhalers, dry powder inhalers and nebulisers. Regulatory aspects of the quality of all of these products are discussed. Students will have the opportunity to conduct an evaluation of a bioavailability study 'in the shoes of' a regulator, with emphasis on European requirements. The chapter on formulation of protein pharmaceuticals explains the particular problems associated with this group of products including stability and compatibility, and describes how the challenges are addressed. Case studies illustrate application of the principles that have been introduced. (An alternative to the topic of protein formulation will be provided for students who are also taking Biopharmaceuticals electives).