Regulatory assessment for controlled drug delivery products

Abstract

The core rationale behind the development of controlled drug delivery systems (DDS) (CDDS) is to adjust the pharmacokinetic and pharmacodynamics of therapeutically active molecules. The principle is to safeguard or augment the therapeutic efficacy of drugs, raise patient compliance, as well as drug safety. In the past few decades, in particular, CRDDS accounted for the majority of the revenue generated from the oral-drug-delivery market. However, CDDS is still regarded as an emerging class of DDS, due to the issues related to the regulatory guidelines as followed by various pharma in the major countries. The regulatory guidelines followed for performance evaluation are typically either the guidelines for modified release systems as a whole or for extended-release products. In this chapter, we discuss the regulatory guideline of CDDS in the United States, Japan, India, South Africa, and the European Union. © 2019 Copyright © 2019 Elsevier Inc. All rights reserved..