ArticleClinical and translational science2019
Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration-Approved Drugs.
Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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Who cites it
17 citing papers in PubMed.
- Population Pharmacokinetic and Exposure-Response Analyses for Ponatinib in the Phase 3 PhALLCON Study.Clinical and translational science · 2025Trial
- The Drug Titration Paradox: Correlation of More Drug With Less Effect in Clinical Data.Clinical pharmacology and therapeutics · 2021Trial
- Questioning assumptions about the abuse potential of medical cannabis and cannabinoids: narrative review and commentary.BJPsych bulletin · 2026Review
- Recommendation of mavacamten posology by model-based analyses in adults with obstructive hypertrophic cardiomyopathy.CPT: pharmacometrics & systems pharmacology · 2024Article
- Assessment of Dosing Strategies for Pediatric Drug Products.Clinical pharmacology and therapeutics · 2024Review
- Dose/exposure-response modeling in dose titration trials: Overcoming the titration paradox.CPT: pharmacometrics & systems pharmacology · 2022Article
- Model enhanced reinforcement learning to enable precision dosing: A theoretical case study with dosing of propofol.CPT: pharmacometrics & systems pharmacology · 2022Article
- Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario.Advances in therapy · 2022Article
- Absorption of the orally active multikinase inhibitor axitinib as a therapeutic index to guide dose titration in metastatic renal cell carcinoma.Investigational new drugs · 2021Article
- Idiosyncratic Drug-Induced Liver Injury: Mechanistic and Clinical Challenges.International journal of molecular sciences · 2021Review
- A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.Clinical pharmacology and therapeutics · 2021Article
- Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting.Clinical pharmacology and therapeutics · 2021Review
- What I have learnt from helping thousands of people taper off antidepressants and other psychotropic medications.Therapeutic advances in psychopharmacology · 2021Review
- Precision Dosing: An Industry Perspective.Clinical pharmacology and therapeutics · 2021Review
- Herbal Preparations of Medical Cannabis: A Vademecum for Prescribing Doctors.Medicina (Kaunas, Lithuania) · 2020Review
- Safety Considerations in Cannabinoid-Based Medicine.International journal of general medicine · 2020Review
- The art and science of drug titration.Therapeutic advances in drug safety · 2020Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Selecting a dose regimen that is both safe and effective for patients is one of the most critical elements of a successful drug development program. Titrating the dose regimen of a drug based on patient response may help to identify safe and effective dosages at the individual patient level. Therefore, we quantified and characterized the use of response-guided titration for drugs recently approved by the US Food and Drug Administration (FDA) to assess how frequently this dosing strategy is used and how titration regimens are evaluated during drug development. Most of the 181 drugs approved from 2013-2017 (78%) had only one approved dosing regimen. Only 30 of 76 (39%) drugs that were considered amenable to response-guided dosing strategies had information in labeling about such strategies. These findings indicate that although response-guided titration can be found in labeling, this strategy is used in a minority of drugs for which it may be useful. Careful consideration should be made early in drug development as to whether a new drug is amenable to response-guided titration as an approach to reducing interpatient variability.
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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.