ArticleClinical and translational science2022
Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies.
Article 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 15 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
15 citing papers in PubMed, 22 citations in OpenAlex.
- Trial
- Dicloxacillin is an inducer of intestinal P-glycoprotein but neither dicloxacillin nor flucloxacillin increases the risk of stroke/systemic embolism in direct oral anticoagulant users.British journal of clinical pharmacology · 2024Trial
- Reply to: Real-world safety signals of isoniazid in adults and children: a complementary FAERS analysis to inform paediatric dose optimisation.The European respiratory journal · 2026Article
- EndoFLIP Guided Assessment of Pyloric Distensibility Identifies Associations With Delayed Gastric Emptying and Symptoms of Gastroparesis.Neurogastroenterology and motility · 2026Article
- Effect of Testosterone Therapy on Cytochrome P450 3A and P-Glycoprotein Activities Using Midazolam and Digoxin as Probe Substrates Among Transgender Adults.Pharmacotherapy · 2026Article
- Affinity- and Format-Dependent Pharmacokinetics ofPharmaceuticals (Basel, Switzerland) · 2026Article
- Apatinib Inhibits the Metabolic Clearance of Ropivacaine: An in vitro and in vivo Evaluation.Drug design, development and therapy · 2026Article
- Limited Sampling Strategies to Predict Mycophenolic Acid and Tacrolimus Area Under the Concentration-Time Curve in Steroid-Free Kidney Transplant Patients.Basic & clinical pharmacology & toxicology · 2025Article
- Genetically Modified Mesenchymal Stromal/Stem Cells as a Delivery Platform for SE-33, a Cathelicidin LL-37 Analogue: Preclinical Pharmacokinetics and Tissue Distribution in C57BL/6 Mice.Antibiotics (Basel, Switzerland) · 2025Article
- Population Pharmacokinetics of IV Lidocaine and its Metabolites in Adult Surgical Patients.Pharmaceutical research · 2025Article
- Innovations in Biosensor Technologies for Healthcare Diagnostics and Therapeutic Drug Monitoring: Applications, Recent Progress, and Future Research Challenges.Sensors (Basel, Switzerland) · 2024Review
- Variability in plasma rifampicin concentrations and role ofInfectious diseases (London, England) · 2024Article
- Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Cytochrome P450 activity in rheumatoid arthritis patients during continuous IL-6 receptor antagonist therapy.European journal of clinical pharmacology · 2023Article
- Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies.Clinical and translational science · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacokinetics is the cornerstone of understanding drug absorption, distribution, metabolism, and elimination. It is also the key to describing variability in drug response caused by drug-drug interactions (DDIs), pharmacogenetics, impaired kidney and liver function, etc. This tutorial aims to provide a guideline and step-by-step tutorial on essential considerations when designing clinical pharmacokinetic studies and reporting results. This includes a comprehensive guide on how to conduct the statistical analysis and a complete code for the statistical software R. As an example, we created a mock dataset simulating a clinical pharmacokinetic DDI study with 12 subjects who were administered 2 mg oral midazolam with and without an inducer of cytochrome P450 3A. We provide a step-by-step guide to the statistical analysis of this clinical pharmacokinetic study, including sample size/power calculation, descriptive statistics, noncompartmental analyses, and hypothesis testing. The different analyses and parameters are described in detail, and we provide a complete R code ready to use in supplementary files. Finally, we discuss important considerations when designing and reporting clinical pharmacokinetic studies. The scope of this tutorial is not limited to DDI studies, and with minor adjustments, it applies to all types of clinical pharmacokinetic studies. This work was done by early career researchers for early career researchers. We hope this tutorial may help early career researchers when getting started on their own pharmacokinetic studies. We encourage you to use this as an inspiration and starting point and continuously evolve your statistical skills.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.