INTRODUCTION

Clinical trials are drug studies that are performed to determine if an investigational medicine meets the effectiveness and safety criteria as has been outlined in the protocol for the clinical trial. Investigational drug products (IDPs) are products not commercially available for the indication or dosage being tested; there may be situations when a commercially available product may be used in a clinical trial as a positive control (comparator), a new indication, or a rescue medication. The term IDP is used throughout this document. Where IDP is used, others may be more familiar with the European Union term investigational medicinal product (IMP). The definition of an IMP is provided in European Commission Directive 2001/20/EC, Article 2 (d), as “a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form”. For the purposes of this chapter, we will consider the two terms as equivalent. The pre-commercial nature of IDPs means the manufacturing ingredients, including active pharmaceutical ingredients (APIs), excipients, the clinical trial dosage, and any associated stability and packaging components may not be as defined as the final approved finished product. The Food and Drug Administration (FDA) current Good Manufacturing Practice regulations for finished drug products apply equally to commercial products and IDPs.