Peter M. Yehl

This paper provides an overview of some current and emerging physicochemical analytical challenges associated with these sophisticated drug systems and some of the technical advances needed in chromatographic systems to enable their design, development, and manufacture.

This fourth and last instalment in the “Separation Science in Drug Development” series provides an overview of modern practices of quality control in small-molecule drug development, including activities such as setting specifications, method validation and transfer, release and stability testing, and authoring chemistry, manufacturing, and controls (CMC) sections of regulatory filings.

This fourth and last installment in the series of “Separation Science in Drug Development” provides an overview of modern practices of Quality Control in small molecule drug development including activities such as setting specifications, method validation/transfer, release and stability testing, and authoring CMC sections of regulatory filings.