(Treffer aus pharmind, Nr. 09, Seite 1296 (2015))
Hebar A | Chabicovsky M
Challenges of and Recommendations for Outsourcing Early Non-Clinical Development Activities / Hebar and Chabicovsky • Outsourcing Early Non-Clinical Development Activities · Hebar A, Chabicovsky M · MC Toxicology Consulting GmbH, Wien (Österreich)
Drug development is a costly and time-consuming process requiring the expertise of specialists of various disciplines. This article shares experience with regard to the selection of contract research organizations (CRO) and provides recommendations for optimal CRO handling. It further outlines most frequent examples of challenges occurring in the interface between the various disciplines required for early drug development with focus on non-clinical safety and toxicity testing. Orchestrating a team including regulatory, toxicology, (bio-)chemistry, (bio-)analytical, and also clinical experts, handling numerous parallel activities is key to a successful path to a first-in-human (FIH) study. The development of medicinal products is a ...