TY - JOUR
T1 - Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products
AU - Cristofoletti, Rodrigo
AU - Rowland, Malcolm
AU - Lesko, Lawrence J.
AU - Blume, Henning
AU - Rostami-hodjegan, Amin
AU - Dressman, Jennifer B.
PY - 2018/10
Y1 - 2018/10
N2 - The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new paradigm has focused on building quality into the product by design and fostering the development of product-specific, clinically relevant specifications. In this context, this commentary describes the evolution of bioequivalence regulations up to the current day and discusses the potential of applying a Bayesian-like approach, considering all relevant prior knowledge, to guide regulatory bioequivalence decisions in a patient-centric environment.
AB - The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new paradigm has focused on building quality into the product by design and fostering the development of product-specific, clinically relevant specifications. In this context, this commentary describes the evolution of bioequivalence regulations up to the current day and discusses the potential of applying a Bayesian-like approach, considering all relevant prior knowledge, to guide regulatory bioequivalence decisions in a patient-centric environment.
U2 - 10.1016/j.xphs.2018.06.013
DO - 10.1016/j.xphs.2018.06.013
M3 - Article
SN - 0022-3549
VL - 107
SP - 2519
EP - 2530
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
IS - 10
ER -