ICH M10: History, publication and initial perspectives on global implementation

Differing bioanalytical method validation and sample analysis requirements among global health authorities have challenged the drug development process, causing inefficiencies and uncertainty. In 2010, regional scientific associations began collaborating in earnest to discuss the challenges created by country-to-country differences. These inter-association discussions resulted in several publications that identified the need for a global bioanalytical guideline and the creation of the Global Bioanalysis Consortium (GBC). Subject matter experts, including scientists from Labcorp Bioanalytical Services (IN, USA), participated in the GBC to develop and publish harmonized best scientific practices.