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Application of a Stable Isotope Approach to Evaluate Impact of Changes in Manufacturing Parameters for an Immediate‐Release Tablet
Author(s) -
Parr Alan,
Badman Geoff,
Bowen Chester L.,
Coffin Mark,
Gupta Manish,
Jones Lori,
Kurtinecz Milena,
Naderer Odin,
Travis Eric,
Zhu John,
Patel Parul
Publication year - 2016
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.664
Subject(s) - harmonization , resource (disambiguation) , computer science , in vivo , quality by design , quality (philosophy) , reduction (mathematics) , pharmacokinetics , risk analysis (engineering) , biochemical engineering , process engineering , reliability engineering , pharmacology , medicine , business , engineering , mathematics , new product development , marketing , microbiology and biotechnology , computer network , philosophy , physics , epistemology , acoustics , biology , geometry
There is continued emphasis from the various worldwide regulatory agencies to ensure that the pharmaceutical industry fully understands the products they are developing. This emphasis is seen via development of quality‐by‐design (QbD) publications and guidelines generated by the International Committee on Harmonization. The challenge to meet these expectations is primarily associated with the generation of in vivo data (eg, pharmacokinetic data) that is resource intensive. A technique reducing the resources needed to generate this in vivo data permits a more extensive application of QbD principles. This paper presents the application of stable isotopes in pharmacokinetic studies. The data show that the use of stable isotopes can significantly reduce the number of subjects required for a study. This reduction in subjects thus translates into a significant reduction in resources and time needed to generate the required in vivo data to support QbD.