Premium
Utility of population pharmacokinetic modeling in the assessment of therapeutic protein‐drug interactions
Author(s) -
Chow Andrew T.,
Earp Justin C.,
Gupta Manish,
Hanley William,
Hu Chuanpu,
Wang Diane D.,
Zajic Stefan,
Zhu Min
Publication year - 2014
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.240
Subject(s) - drug , drug development , risk analysis (engineering) , pharmacology , population , pharmaceutical industry , pharmacokinetics , medicine , computer science , management science , intensive care medicine , engineering , environmental health
Assessment of pharmacokinetic (PK) based drug–drug interactions (DDI) is essential for ensuring patient safety and drug efficacy. With the substantial increase in therapeutic proteins (TP) entering the market and drug development, evaluation of TP‐drug interaction (TPDI) has become increasingly important. Unlike for small molecule (e.g., chemical‐based) drugs, conducting TPDI studies often presents logistical challenges, while the population PK (PPK) modeling may be a viable approach dealing with the issues. A working group was formed with members from the pharmaceutical industry and the FDA to assess the utility of PPK‐based TPDI assessment including study designs, data analysis methods, and implementation strategy. This paper summarizes key issues for consideration as well as a proposed strategy with focuses on (1) PPK approach for exploratory assessment; (2) PPK approach for confirmatory assessment; (3) importance of data quality; (4) implementation strategy; and (5) potential regulatory implications. Advantages and limitations of the approach are also discussed.