Microdose Studies/Mass Balance Test
The mass balance test assesses absorption, distribution, metabolism and excretion of the drug metabolites at as early a stage as possible, and can keep you from delays in drug developments.
In the FDA guidelines, it is mentioned that "human metabolites that can raise a safety concern are those formed at greater than 10 percent of parent drug systemic exposure at steady state".
By testing the mass balance of the new investigational drug, we can more closely see the bigger picture relating to the parent drug PK and also metabolite PK.
The term microdose is defined as a 1/100th of the clinical doses as determined from animal studies, or 100 μg of the drug. Because the nature of the microdose requires sophisticated and trained techniques, finding an experienced investigational site will govern the fate of the clinical trial.
Since our first microdose study using 14C radiolabeling and AMS was conducted in 2009 at our clinical research center, we have conducted 8 protocols with 154 subjects as of 2019.
We help our clients save both time and money, getting quick estimates about investigational drug efficacy at a very early stage of the drug's development.
If you are interested in microdose studies Contact us here.
"Microdose Study of 14C-Acetaminophen With Accelerator Mass Spectrometry to Examine Pharmacokinetics of Parent Drug and Metabolites in Healthy Subjects"
Clin Pharmacol Ther 88: 824-830 (2010).
"Pharmacokinetic and pharmacogenomic profiles of telmisartan after the oral microdose and therapeutic dose"
"Pharmacogenomic/pharmacokinetic assessment of a four-probe cocktail for CYPs and OATPs following oral microdosing"
International Journal of Clinical Pharmacology and TherapeuticsVol.50-No.10/2012（689-700）
"Microdosing clinical study:pharmacokinetic,pharmacogenomic(SLCO2B1),and interaction(grapefruit juice)profiles of celiprolol following the oral microdose and therapeutic dose"
J Clin Pharmacol.2012Jul;52(7):1078-89
- "Mechanisms of pharmacokinetic enhancement between ritonavir and saquinavir; micro/small dosing tests using midazolam (CYP3A4), fexofenadine (p-glycoprotein), and pravastatin (OATP1B1) as probe drugs" J Clin Pharmacol2013 Jun;53(6):654-61. doi: 10.1002/jcph.62. Epub 2013 Feb 4
- "A phase I, open-label, single-dose micro tracer mass balance study of C14-labeled ASP 7991 in healthy Japanese male subjects using accelerator mass spectrometry"
Drug Metabolism and Pharmacokinetics 33(2018) 118-124