Clinical Pharmacology Review of Plasma-derived and Recombinant Protein Products: CBER Experience and Perspectives on Model-Informed Drug Development.
Million A TegengeIftekhar MahmoodRichard ForsheePublished in: Haemophilia : the official journal of the World Federation of Hemophilia (2019)
In conclusion, clinical pharmacology has played a major role in regulatory review of plasma-derived products, and we expect that the application of quantitative methods will further evolve for these products under the FDA MIDD programme.