Eric N. Fluhler, Ph.D., is executive director and compliance lead for World Wide Pharmacokinetics, Dynamics and Metabolism, with Pfizer. He is the chair of the AAPS Bioanalytical Focus Group and serves as team leader for the Global Bioanalytical Consortium’s repeat analysis and ISR team.
For many years, there were limited regulations that addressed the conduct of bioanalytical method validations and sample analyses in good laboratory practice (GLP) nonclinical and clinical studies. And before their advent, the growing importance of pharmacokinetic results in determining the safety and efficacy of new drug entities warranted a discussion between industry practitioners and regulatory authorities.
Over the past 23 years, the American Association of Pharmaceutical Scientists (AAPS) has been actively involved in establishing scientific standards and best practices for bioanalytical method validations and sample analyses in GLP nonclinical and clinical studies. AAPS’ activities have taken many forms and involved interactions with a number of collaborative organizations and health authorities. As the pharmaceutical industry has changed and gained a more global perspective, AAPS members from the Analysis and Pharmaceutical Quality (APQ) and Biotechnology sections, mainly lead by the Bioanalytical focus group and the Ligand Binding Assay Bioanalytical focus group, have championed the need for science-based regulations and most recently for globally harmonized bioanalytical regulations. Activities have included four “Crystal City” conferences, numerous AAPS Annual Meeting and Exposition programs, and most recently, leadership and participation in the Global Bioanalysis Consortium (GBC).
The article Driving toward Bioanalytical Regulatory Harmonization: AAPS and the Global Bioanalysis Consortium, featured in the September issue of the AAPS Newsmagazine and developed by the APQ section, outlines the background leading to the GBC’s formation, its expansion to represent all regions of the world, and its development of recommendations for harmonizing regulations. Read the article and then participate in the discussion question below.
Discussion Point: What should the next steps be for the GBC best practice recommendations once published?