Clinical trials of suspension drug products

Abstract

Clinical trials of a pharmaceutical product, regardless of the pharmaceutical form, are generally required by the regulatory agencies around the world as the basis for proof of safety and efficacy in the drug product approval process. Such clinical trials must be conducted in an ethical manner according to a protocol. Some of the most important aspects of clinical trials specific to suspension drug products are concerned with the clinical supplies. Blinding is particularly difficult for suspension drug products since many approved comparators are not suspensions, thus making it very challenging to mask the investigational suspension versus its comparators. Appropriate choices for globally acceptable clinical study design of suspension drug products are discussed.