Regis Technologies' Director of Analytical Method Development delivered this presentation on "Analytical Method Strategies for Drug Development" for Regis staff and guests. Part 4 of 6.
ABSTRACT: Analytical development is the series of method development and validation tasks
required to bring a drug candidate into animal safety studies, through clinical trials, and ultimately,
commercial sales. The required tasks get more stringent as the program moves toward commercial. The challenge is in knowing these requirements for each stage of the candidate drug evolution, for instance, what is necessary to support a Phase-1 IND or a generic ANDA. Regulatory agencies like the FDA and EMEA, compendial sources such as the US and European pharmacopeias, and harmonization efforts like ICH provide guidances at steps along the path. Analytical Development is divided into two key areas, namely Active Pharmaceutical Ingredients and drug products, the former to be the focus for this presentation. Strategies for method development and validation will be discussed, with the information reflecting industry best practices, and based on numerous projects from a CMO perspective.