ReviewClinical and translational science2022
Human radiolabeled mass balance studies supporting the FDA approval of new drugs.
Review in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed.
- Regulatory Considerations for Combined Drug-Device Studies in Europe: A Case Study Involving Bile Sampling.Pharmaceutical medicine · 2026Review
- Human Radiolabeled Mass Balance Studies Supporting New Drugs Approved by FDA Between 2019 and 2023.Clinical and translational science · 2026Article
- Mass balance study of [European journal of clinical pharmacology · 2026Article
- Design characteristics of mass balance studies conducted for protein kinase inhibitors.Cancer chemotherapy and pharmacology · 2026Article
- Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends.Clinical pharmacology and therapeutics · 2026Review
- Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer.Clinical and translational science · 2026Review
- Ecopipam, a Dopamine D1 Receptor Antagonist: Pharmacokinetics, Mass Balance, and Metabolism in Healthy Volunteers.Clinical and translational science · 2026Article
- A Phase 1 Oral Mass Balance and Combined Intravenous [Journal of clinical pharmacology · 2026Article
- Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance Assessment, and Strategic Decision Making.Drug safety · 2026Review
- Mass balance, excretion, and pharmacokinetics of a single oral dose of [Frontiers in pharmacology · 2026Article
- Mass balance and metabolite profiling ofXenobiotica; the fate of foreign compounds in biological systems · 2026Article
- Mass Balance and Metabolism ofClinical and translational science · 2025Article
- Microtracer-Based Assessment of the Mass Balance, Pharmacokinetics, and Excretion of [Clinical pharmacology in drug development · 2025Article
- Pharmacometabolomics Study of Sulfamethoxazole and Trimethoprim in Kidney Transplant Recipients: Real-World Metabolism and Urinary Excretion.Metabolites · 2025Article
- Oral paltusotine, a nonpeptide selective somatostatin receptor 2 agonist: Mass balance, absolute bioavailability and metabolism in healthy participants.British journal of clinical pharmacology · 2025Article
- Pharmacometabolomics Detects Various Unreported Metoprolol Metabolites in Urine of (Potential) Living Kidney Donors and Kidney Transplant Recipients.Clinical pharmacokinetics · 2025Article
- Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor.Clinical pharmacology in drug development · 2025Article
- Pharmacokinetics and ADME Characterization After Oral and Intravenous Administration of [Clinical and translational science · 2025Article
- Article
- Pharmacometabolomics Enables Real-World Drug Metabolism Sciences.Metabolites · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Human radiolabeled mass balance studies are an important component of the clinical pharmacology programs supporting the development of new investigational drugs. These studies allow for understanding of the absorption, distribution, metabolism, and excretion of the parent drug and metabolite(s) in the human body. Understanding the drug's disposition as well as metabolite profiling and abundance via mass balance studies can help inform the overall drug development program. A survey of the US Food and Drug Administration (FDA)-approved new drug applications (NDAs) indicated that about 66% of the drugs had relied on findings from the mass balance studies to help understand the pharmacokinetic characteristics of the drug and to inform the overall drug development program. When such studies were not available in the original NDA, adequate justifications were routinely provided. Of the 104 mass balance studies included in this survey, most of the studies were conducted in healthy volunteers (90%) who were mostly men (>86%). The studies had at least six evaluable participants (66%) and were performed using the final route(s) of administration (98%). Eighty-five percent of the studies utilized a dose within the pharmacokinetic linearity range with 54% of the studies using a dose the same as the approved dose. Nearly all studies were performed as a single-dose (97%) study using a fit-for-purpose radiolabeled formulation. In this analysis, we summarized the current practices for conducting mass balance studies and highlighted the importance of conducting appropriately designed human radiolabeled mass balance studies and the challenges associated with inadequately designed or untimely studies.
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