CRO commentary on the importance of harmonization and the impact of the ICH M10

Want to stay updated with the latest news and gain exclusive access to Bioanalysis journal articles? Become a member for free. Key words: bioanalysis, CRO, GCC, global, guidance, harmonization, ICH M10, validation Global harmonization of best practices in bioanalysis has been a goal within the bioanalytical industry for quite a number of years, dating back as far as the first so-called ‘Crystal City’ meeting in 1990. That meeting, sponsored by the American Association of Pharmaceutical Scientists along with the US FDA, started the development of the initiative to introduce consistent guidelines across the regulated bioanalytical industry. These efforts ultimately lead to...