Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
|Articles|February 26, 2016
Comparator Sourcing
Author(s)Catalent
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.
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