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Opportunities and Challenges Related to the Implementation of Model‐Based Bioequivalence Criteria
Author(s) -
Seng Yue Corinne,
Ozdin Deniz,
SelberHnatiw Susannah,
Ducharme Murray P.
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1270
Subject(s) - bioequivalence , strengths and weaknesses , computer science , management science , econometrics , mathematics , medicine , economics , pharmacology , psychology , pharmacokinetics , social psychology
The science of bioequivalence and biosimilarity has greatly evolved over the past 3 decades. Current methods for assessing bioequivalence mostly rely on noncompartmental pharmacokinetic (PK) analyses, which have proven to be reliable and robust for most products. However, the development of more complex products is forcing scientists and regulators to consider alternative approaches, including those derived from model‐based population PK analyses. This article will examine the strengths and weaknesses of standard noncompartmental methods and compare them to model‐based approaches, including a comparison of metrics associated with each method. Specific situations for which model‐based approaches could prove to be more suitable will be presented, as well as potential bioequivalence metrics that could be considered for bioequivalence comparisons. The opportunities and challenges that are associated with these novel methods will also be discussed.