ArticleClinical pharmacokinetics2011
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Article in Clinical pharmacokinetics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers.
What it found
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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
63 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
- How Semiphysiological Population Pharmacokinetic Modeling Incorporating Active Hepatic Uptake Supports Phase II Dose Selection of RO7049389, A Novel Anti-Hepatitis B Virus Drug.Clinical pharmacology and therapeutics · 2021Trial
- Exposure-safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate.Acta neurologica Scandinavica · 2018Trial
- Exposure-Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Trial
- 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
- Can an early phase clinical pharmacology study replace a thorough QT study? Experience with a novel H3-receptor antagonist/inverse agonist.European journal of clinical pharmacology · 2016Trial
- 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
- Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost.Clinical pharmacology and therapeutics · 2025Article
- Advancing rare disease therapeutics through digital twins: Opportunities in drug development and precision dosing.Computational and structural biotechnology journal · 2025Review
- Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024Review
- A pharmacokinetic model of antiseizure medication load to guide care in the epilepsy monitoring unit.Epilepsia · 2023Article
- Pharmacometrics: A New Era of Pharmacotherapy and Drug Development in Low- and Middle-Income Countries.Advances in pharmacological and pharmaceutical sciences · 2023Review
- Systematic Evaluation of Voriconazole Pharmacokinetic Models without Pharmacogenetic Information for Bayesian Forecasting in Critically Ill Patients.Pharmaceutics · 2022Article
- 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
- Extended or Continuous Infusion of Carbapenems in Children with Severe Infections: A Systematic Review and Narrative Synthesis.Antibiotics (Basel, Switzerland) · 2021Review
- Pharmacokinetic Modeling and Predictive Performance: Practical Considerations for Therapeutic Monoclonal Antibodies.European journal of drug metabolism and pharmacokinetics · 2021Article
- End-to-end application of model-informed drug development for ertugliflozin, a novel sodium-glucose cotransporter 2 inhibitor.CPT: pharmacometrics & systems pharmacology · 2021Review
- A Model-Informed Drug Development (MIDD) Approach for a Low Dose of Empagliflozin in Patients with Type 1 Diabetes.Pharmaceutics · 2021Article
3 more citing papers are in PubMed but not listed here.
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions. Pharmacometrics is defined as a science that quantifies drug, disease and trial information to aid drug development, therapeutic decisions and/or regulatory decisions. In this report, we present the results of a survey evaluating the impact of pharmacometric analyses on regulatory decisions for 198 submissions during the period from 2000 to 2008. Pharmacometric review of NDAs included independent, quantitative analyses by FDA pharmacometricians, even when such analysis was not conducted by the sponsor, as well as evaluation of the sponsor's report. During 2000-2008, the number of reviews with pharmacometric analyses increased dramatically and the number of reviews with an impact on approval and labelling also increased in a similar fashion. We also present the impact of pharmacometric analyses on selection of paediatric dosing regimens, approval of regimens that had not been directly studied in clinical trials and provision of evidence of effectiveness to support a single pivotal trial. Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making.
Indexed as
Identifiers
21895036What 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.