This FDA Guidance has a narrow scope as described in the Introduction:
"This guidance describes the FDA's recommendations regarding clinical pharmacology
considerations for conducting human radiolabeled mass balance studies of investigational drugs,
including: (1) deciding whether and when to conduct the study, (2) designing the study, and (3)
reporting results.2 The recommendations in this guidance are, in part, based on the FDA's
experience reviewing human radiolabeled mass balance studies submitted to the Agency in
recent new drug applications (NDAs).3 This guidance does not cover animal mass balance
studies, safety testing of drug metabolites, or recommendations for selecting the radioactivity
dose."
In the Background section, a succinct statement on why radiolabeled mass balance studies are conducted:
"A human radiolabeled (most commonly 14C or 3H) mass balance study is the single most direct method to obtain quantitative and comprehensive information on the absorption, distribution, metabolism, and excretion (ADME) of the drug in the human body."
#fda #massbalance #radiolabeled #Guidance
Clin Pharm Considerations for Human Radiolabeled Mass Balance Studies
| U.S. Food and Drug Administration |
remove preview |
|
|
------------------------------
Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
------------------------------
</bioanalysisandbiomarkers.blogspot.com>