Comparator Sourcing
As more drug companies adopt comparative effectiveness studies, drug supply professionals are challenged with sourcing and managing comparator drugs. This ebook examines research from the Tufts Center for the Study of Drug Development, and reviews the pros and cons of the transactional and strategic comparator sourcing models to aid in the development of effective sourcing approaches. Special considerations, and commonly encountered issues in biologics sourcing are discussed. In addition, areas to consider in equivalence testing for comparability are reviewed.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
