Journals on Medical Microbiology

Abstract

Building a safety assessment package to go into the #PhaseI clinical stage sounds simple enough. All the steps pertaining to#preclinicaltesting, pharmaceutical development, clinical supplies manufacturing, and regulatory submissions are all clearly defined within a repertoire of guidelines that outline the acceptable requirements. The timelines to enter into Phase I clinical trials are becoming increasingly shorter as companies seek definitive results that would prove or disprove their #drug’spotential. Gathering the maximum of information with regards to safety, efficacy and galenic aspects of the drug during early stages of drug development is often a challenge when faced with stresses of aggressive timelines, financial constraints and investor milestones.

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Are You Ready to Take Your Drug Product from Phase I Studies to the Subsequent Phases? by Francois-Xavier Lacasse in BJSTR