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Bioanalysis
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Future Drug Discovery
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International Journal of Pharmacokinetics
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Therapeutic Delivery
PerspectiveFree Access

Lessons learned from regulatory submissions involving endogenous therapeutic analyte bioanalysis

    Chongwoo Yu

    *Author for correspondence: Tel.: +1 301 796 2335;

    E-mail Address: chongwoo.yu@fda.hhs.gov

    Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA

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    ,
    Wenlei Jiang

    Office of Research & Standards (ORS), Office of Generic Drugs (OGD), CDER, US FDA, Silver Spring, MD 20993, USA

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    ,
    Murali Matta

    Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA

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    ,
    Rong Wang

    Office of Bioequivalence (OB), OGD, CDER, US FDA, Silver Spring, MD 20993, USA

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    ,
    Sam Haidar

    Office of Study Integrity & Surveillance (OSIS), OTS, CDER, US FDA, Silver Spring, MD 20993, USA

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    &
    Hyeonglim Seo

    Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA

    Department of Chemistry & Biochemistry, University of California San Diego, La Jolla, CA 92093, USA

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    Published Online:13 Dec 2023

    Abstract

    Endogenous therapeutic analytes include hormones, neurotransmitters, vitamins, fatty acids and inorganic elements that are naturally present in the body because either the body produces them or they are present in the normal diet. The accurate measurement of endogenous therapeutic analytes poses a challenge when the administered exogenous therapeutic analyte and its endogenous counterpart cannot be distinguished. In this article, real case examples with endogenous therapeutic analyte bioanalysis during drug development in support of regulatory submissions are collected and presented. The article highlights common challenges encountered and lessons learned related to bioanalysis of endogenous therapeutic analytes and provides practical tips and strategies to consider from a regulatory perspective.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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