ArticleClinical pharmacology and therapeutics2018
Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use.
Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 16 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
16 citing papers in PubMed, 24 citations in OpenAlex.
- Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B-Cell Hematological Malignancies.Clinical pharmacology and therapeutics · 2021Trial
- Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective.Frontiers in medicine · 2024Article
- Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma.CPT: pharmacometrics & systems pharmacology · 2023Article
- A Quantitative Modeling and Simulation Framework to Support Candidate and Dose Selection of Anti-SARS-CoV-2 Monoclonal Antibodies to Advance Bamlanivimab Into a First-in-Human Clinical Trial.Clinical pharmacology and therapeutics · 2022Article
- Early Feasibility Assessment: A Method for Accurately Predicting Biotherapeutic Dosing to Inform Early Drug Discovery Decisions.Frontiers in pharmacology · 2022Article
- Using mathematical modeling to estimate time-independent cancer chemotherapy efficacy parameters.In silico pharmacology · 2022Article
- Pharmacometrics meets statistics-A synergy for modern drug development.CPT: pharmacometrics & systems pharmacology · 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 Discovery and Development Strategy for the Novel Glucose-Responsive Insulin MK-2640 Enabled Rapid Decision Making.Clinical pharmacology and therapeutics · 2020Article
- Progress and Opportunities to Advance Clinical Cancer Therapeutics Using Tumor Dynamic Models.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Review
- MID3: Mission Impossible or Model-Informed Drug Discovery and Development? Point-Counterpoint Discussions on Key Challenges.Clinical pharmacology and therapeutics · 2020Article
- Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network.CPT: pharmacometrics & systems pharmacology · 2019Article
- Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.CPT: pharmacometrics & systems pharmacology · 2019Article
- PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development.CPT: pharmacometrics & systems pharmacology · 2019Article
- Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology.Frontiers in immunology · 2019Review
- Clinical Studies for the Sake of Negative Data: The Proof Is in the Pudding.Clinical and translational science · 2018Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Quantitative pharmacology (QP) applications in translational medicine, drug-development, and therapeutic use were crowd-sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial-burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model-informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy.
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.