2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Area of Science:

• Bioanalysis
• Analytical Chemistry
• Pharmaceutical Science

Background:

• The 8th Workshop on Recent Issues in Bioanalysis (WRIB) gathered 500+ global professionals.
• Discussions focused on challenges in small and large molecule bioanalysis, including LC-MS, hybrid LBA/LCMS, LBA, and immunogenicity.
• This white paper is the first of three parts, focusing on LC-MS for small molecule bioanalysis.

Framework:

• The workshop provided a platform for experts from pharmaceutical companies, CROs, and regulatory agencies.
• Collaborative discussions aimed to establish consensus on current bioanalytical issues.
• Recommendations are based on shared expertise and regulatory considerations.

Implementation:

• This paper details recommendations for small molecule bioanalysis utilizing Liquid Chromatography-Mass Spectrometry (LC-MS).
• The content is derived from extensive discussions and agreements reached during the 5-day workshop.
• Practical guidance is provided to enhance scientific excellence and quality in bioanalytical methods.

Implications:

• The recommendations serve as a practical guide for the bioanalytical community.
• This work aims to foster advancements in scientific rigor and regulatory compliance.
• Future parts will cover hybrid LBA/LCMS, ELN, regulatory input, large molecule bioanalysis, and immunogenicity.