The course begins with an introduction to dosage forms, and describes their design, development and manufacture using tablets as an example. The relevance of the properties of active ingredients to product development is discussed. Concepts of sterility and sterilisation are introduced. The chapter on product quality outlines concepts of quality, quality assurance and quality control, discusses the significance of pharmacopoeial monographs, and gives reasons for the various tests of quality for raw materials and finished products. The fundamental relationship between ongoing quality and Good Manufacturing Practice is discussed, together with examples of validation of later changes or variations to products. Particular attention is given to methods of testing for impurity content, the significance of different types of impurity, disintegration and dissolution testing, and the design and interpretation of stability studies. The final chapter outlines the design, conduct and reporting of bioavailability and bioequivalence studies, and describes formulation strategies for drugs which have limited bioavailability.

Note: The course is compulsory for programmes 5504, and 9060.