The stability data requirements for human pharmaceuticals in the European Community (EC)
are based on a series of Directive and Regulation requirements and on a series of advisory …

The International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) provides for …

Regulatory stability testing requirements for various types of ophthalmic products, including
eyedrops, eye ointments, ophthalmic inserts, injections, irrigating solutions, lens washes, …

… Brian R. Matthews …

In this chapter consideration is given to deficiencies encountered in applications for product
licences (marketing authorisations) submitted to the United Kingdom (UK) Medicines Control …

What Is an Excipient? What is an excipient? For the purposes of this chapter, it will be taken
to mean any component in a pharmaceutical formulation other than the active ingredient or a …

INTRODUCTION Manufacture of the finished product (also known as the drug product) is
one topic that will be required to be addressed for all applications for Marketing Authorization …

This chapter includes a discussion of the control of medicated devices in the Member States
of the European Community (EC). In 1987 this would have involved a listing of the different …

INTRODUCTION This chapter will consider the factors associated with combinations of
medical devices and pharmaceuticals particularly with respect to nonbiological sourced …

INTRODUCTION In the context of this chapter “biological” products are those which are
based on or frequently contain materials of human or animal origin. These products not only …