Summary of Invention
Dosing regimens are usually determined by time-consuming, costly laboratory, animal and clinical experiments, or by using dosing schedules that had been established for other known therapeutic agents, or by trial and error. The present method is scientifically based to generate the optimal dosing regimen, including duration of treatment, in clinical trials and in therapy, comparing data from the progression of an untreated disease and data from the progression of the same disease while a particular treatment is administered, in a computational model. The method was validated for cancerous tumors, specifically colon and breast cancer, but it is universal.
- The determination of dosing regimen and duration of therapeutic treatment is based on minimal data, and avoids the guesswork of using regimens established for different drugs, or trial and error.
- This method is posed to become the standard for planning and executing clinical trials, thereby allowing more rational comparisons among clinical trial results and treatments.
- The method determines the optimum regimens thereby minimizing patient suffering and stress.
- The method determines the optimum regimens thereby potentially saving large amounts of funds dedicated to clinical trials and treatments.
- Use of the method could help in accelerating the approval process.
- Disclosure of regimens on labels based on the Norton Dosing Method may provide assurances to doctors and patients.
Areas of Application
- Determination of dosing regimens and duration of therapeutic treatment involving experimental or approved drugs.
- Planning clinical trials.
- Although designed for oncology, it may be useful in other fields.
Stage of Development
Ready to be used
Larry Norton, MD
U.S. patent application published: US2006/0224049
Lisa Placanica, PhD
Tel: 212-639-6181; Fax: 212-717-3439