Tim graduated as Clinical Chemistry Technician at the Radius College in Breda, the Netherlands and is travelling around the world as one of Eurofins Central Laboratory’s Travelling Laboratory Technicians. Tim is one of Eurofins’ Quiet Heroes, standing between you and the hazards of an ever-changing, highly complex world, making sure you can trust the medicines you depend on.
Tags: Central Laboratory, Quality, Testicular Toxicity, Clinical Trial, Drug Development, Development, BioPharma, Quiet Hero
After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:
Tags: FDA, Central Laboratory, Testicular Toxicity, Clinical Trial