ReviewThe AAPS journal2005
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
Review in The AAPS journal, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 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
44 citing papers in PubMed.
- Recommended Phase II Doses of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma From MonumenTAL-1: Clinical Pharmacology Results.Clinical pharmacology and therapeutics · 2025Trial
- Exposure-safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate.Acta neurologica Scandinavica · 2018Trial
- Application of Exposure-Response Analyses to Establish the Pharmacodynamic Similarity of a Once-Daily Regimen to an Approved Twice-Daily Dosing Regimen for the Treatment of HCV Infection.The AAPS journal · 2017Trial
- The Creating an Optimal Warfarin Nomogram (CROWN) Study.Thrombosis and haemostasis · 2012Trial
- Quantitative pharmacology approach in Alzheimer's disease: efficacy modeling of early clinical data to predict clinical outcome of tesofensine.The AAPS journal · 2010Trial
- Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children.Antimicrobial agents and chemotherapy · 2010Trial
- Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.British journal of clinical pharmacology · 2008Trial
- Four Decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)-Part II: Dose Individualization and Approvability Evidence.The AAPS journal · 2026Review
- Application of Model-Informed Approaches in Neuroscience Drug Development and Regulatory Decision-Making.Journal of clinical pharmacology · 2026Review
- PKGPT: Expert-Orchestrated Recursive LLM Agent for Automated NONMEM PopPK Modeling with Human Benchmarking.Pharmaceutics · 2026Article
- SCOUT: An Exploratory Approach to Scouting Dose-Relevant Covariates.CPT: pharmacometrics & systems pharmacology · 2026Article
- A pharmacokinetic model of antiseizure medication load to guide care in the epilepsy monitoring unit.Epilepsia · 2023Article
- Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development.CPT: pharmacometrics & systems pharmacology · 2022Review
- Age-Related Change in Hepatic Clearance Inferred from Multiple Population Pharmacokinetic Studies: Comparison with Renal Clearance and Their Associations with Organ Weight and Blood Flow.Clinical pharmacokinetics · 2022Article
- Optimal use of intravenous tranexamic acid for hemorrhage prevention in pregnant women.American journal of obstetrics and gynecology · 2021Article
- Time to Expect More From Pharmacometrics.Clinical pharmacology and therapeutics · 2020Article
- Nursing Personnel in the Era of Personalized Healthcare in Clinical Practice.Journal of personalized medicine · 2020Review
- The Steps to Therapeutic Drug Monitoring: A Structured Approach Illustrated With Imatinib.Frontiers in pharmacology · 2020Review
- Orphan drug development: the increasing role of clinical pharmacology.Journal of pharmacokinetics and pharmacodynamics · 2019Review
- Pharmacometrics and systems pharmacology for metabolic bone diseases.British journal of clinical pharmacology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression is often referred to as the pharmacometrics analyses. The objective of the current report is to assess the role of pharmacometrics at the US Food and Drug Administration (FDA) in making drug approval and labeling decisions. The New Drug Applications (NDAs) submitted between 2000 and 2004 to the Cardio-renal, Oncology, and Neuropharmacology drug products divisions were surveyed. For those NDA reviews that included a pharmacometrics consultation, the clinical pharmacology scientists ranked the impact on the regulatory decision(s). Of about a total of 244 NDAs, 42 included a pharmacometrics component. Review of NDAs involved independent, quantitative evaluation by FDA pharmacometricians, even when such analysis was not conducted by the sponsor. Pharmacometric analyses were pivotal in regulatory decision making in more than half of the 42 NDAs. Of the 14 reviews that were pivotal to approval related decisions, 5 identified the need for additional trials, whereas 6 reduced the burden of conducting additional trials. Collaboration among the FDA clinical pharmacology, medical, and statistical reviewers and effective communication with the sponsors was critical for the impact to occur. The survey and the case studies emphasize the need for early interaction between the FDA and sponsors to plan the development more efficiently by appreciating the regulatory expectations better.
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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.