In this article, Ori Ben-David, PhD, Vice-President of Research and Development, Pharmaceutical Solutions, at Eitan Medical, discusses the considerations that must be made over the course of injectable drug development and how the company’s Sapphire™ and Sorrel™ platforms offer pharmaceutical companies a full suite of device tools from early discovery through to commercialization.
The drug development process
As colleagues in the pharmaceutical industry can attest to, there are multiple stages in the drug development cycle, ranging in length and complexity, all of which must be passed successfully prior to commercialisation and market introduction of a new drug product (Figure 1). In the early discovery and development stages, a pharmaceutical company will conduct the necessary research to develop a new chemical or biological entity, initially testing it in preclinical animal studies, followed by three phases of clinical trials to determine the safety, efficacy, and therapeutic effects of the medication. Following the successful completion of clinical studies and subsequent clearance by the relevant regulatory authorities, the drug can then be prepared for commercial launch.
Figure 1: The drug development process as outlined by the US FDA¹