A novel pharmacokinetic model used to titrate therapy for implantable testosterone pellets (Testopel®) in a clinical patient is presented. The model accurately reflects measurements by the Esoterix Laboratory’s serum testosterone assay. The difference between the model’s predictions and the measured levels were clinically insignificant (mean absolute % difference = 2.9%, mean % difference = 0.40%, SD = 4.6%, n = 9), during the early, development phase of the model, and remained small (mean absolute % difference = 5.2%, mean % difference = -1.3%, SD = 7.7%, n = 13) even when newer data points were included. The model was used to predict the peak (900-1100 ng/dL), trough (>300 ng/dL), and average total serum testosterone levels at steady state. Subsequently, the model was used to alter the treatment regimen to yield a specific average serum testosterone level (“area under the curve” ~600 ng/dL), to keep the serum peak under a target amount (<800 ng/dL), and to keep the serum trough above a certain amount (> 400 ng/dL). Targeted levels were reached by the next cycle of Testopel® therapy. This represents the first time such a close correlation between a predicted and a measured serum testosterone has been shown using any assay. Because of the accuracy of the model, the authors recommend using it to provide a quantitative approach to the initiation and maintenance of Testopel® therapy instead of the traditional, more qualitative trial-and-error technique. Clinicians can now target average, peak, and trough testosterone levels and we can reach those levels by the second cycle of therapy. It is likely the model can be extended to aid treatment with implantable testosterone pellets other than Testopel®. This paper presents a detailed analysis of our pharmacokinetic model and its usage as a clinical aid.
| Published in | International Journal of Clinical Urology (Volume 6, Issue 2) |
| DOI | 10.11648/j.ijcu.20220602.16 |
| Page(s) | 95-113 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2022. Published by Science Publishing Group |
Testosterone Implant, Implantation, Testopel® Pharmacokinetic Model, Testosterone Supplementation, Total Serum Testosterone, Steady State Levels
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APA Style
David T. Seitman M. S. BME, M. D., Joe J. Fallon M. D. (2022). A Detailed Analysis of a Pharmacokinetic Model for Testopel® Implants. International Journal of Clinical Urology, 6(2), 95-113. https://doi.org/10.11648/j.ijcu.20220602.16
ACS Style
David T. Seitman M. S. BME; M. D.; Joe J. Fallon M. D. A Detailed Analysis of a Pharmacokinetic Model for Testopel® Implants. Int. J. Clin. Urol. 2022, 6(2), 95-113. doi: 10.11648/j.ijcu.20220602.16
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Download@article{10.11648/j.ijcu.20220602.16,
author = {David T. Seitman M. S. BME and M. D. and Joe J. Fallon M. D.},
title = {A Detailed Analysis of a Pharmacokinetic Model for Testopel® Implants},
journal = {International Journal of Clinical Urology},
volume = {6},
number = {2},
pages = {95-113},
doi = {10.11648/j.ijcu.20220602.16},
url = {https://doi.org/10.11648/j.ijcu.20220602.16},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcu.20220602.16},
abstract = {A novel pharmacokinetic model used to titrate therapy for implantable testosterone pellets (Testopel®) in a clinical patient is presented. The model accurately reflects measurements by the Esoterix Laboratory’s serum testosterone assay. The difference between the model’s predictions and the measured levels were clinically insignificant (mean absolute % difference = 2.9%, mean % difference = 0.40%, SD = 4.6%, n = 9), during the early, development phase of the model, and remained small (mean absolute % difference = 5.2%, mean % difference = -1.3%, SD = 7.7%, n = 13) even when newer data points were included. The model was used to predict the peak (900-1100 ng/dL), trough (>300 ng/dL), and average total serum testosterone levels at steady state. Subsequently, the model was used to alter the treatment regimen to yield a specific average serum testosterone level (“area under the curve” ~600 ng/dL), to keep the serum peak under a target amount ( 400 ng/dL). Targeted levels were reached by the next cycle of Testopel® therapy. This represents the first time such a close correlation between a predicted and a measured serum testosterone has been shown using any assay. Because of the accuracy of the model, the authors recommend using it to provide a quantitative approach to the initiation and maintenance of Testopel® therapy instead of the traditional, more qualitative trial-and-error technique. Clinicians can now target average, peak, and trough testosterone levels and we can reach those levels by the second cycle of therapy. It is likely the model can be extended to aid treatment with implantable testosterone pellets other than Testopel®. This paper presents a detailed analysis of our pharmacokinetic model and its usage as a clinical aid.},
year = {2022}
}
TY - JOUR T1 - A Detailed Analysis of a Pharmacokinetic Model for Testopel® Implants AU - David T. Seitman M. S. BME AU - M. D. AU - Joe J. Fallon M. D. Y1 - 2022/10/29 PY - 2022 N1 - https://doi.org/10.11648/j.ijcu.20220602.16 DO - 10.11648/j.ijcu.20220602.16 T2 - International Journal of Clinical Urology JF - International Journal of Clinical Urology JO - International Journal of Clinical Urology SP - 95 EP - 113 PB - Science Publishing Group SN - 2640-1355 UR - https://doi.org/10.11648/j.ijcu.20220602.16 AB - A novel pharmacokinetic model used to titrate therapy for implantable testosterone pellets (Testopel®) in a clinical patient is presented. The model accurately reflects measurements by the Esoterix Laboratory’s serum testosterone assay. The difference between the model’s predictions and the measured levels were clinically insignificant (mean absolute % difference = 2.9%, mean % difference = 0.40%, SD = 4.6%, n = 9), during the early, development phase of the model, and remained small (mean absolute % difference = 5.2%, mean % difference = -1.3%, SD = 7.7%, n = 13) even when newer data points were included. The model was used to predict the peak (900-1100 ng/dL), trough (>300 ng/dL), and average total serum testosterone levels at steady state. Subsequently, the model was used to alter the treatment regimen to yield a specific average serum testosterone level (“area under the curve” ~600 ng/dL), to keep the serum peak under a target amount ( 400 ng/dL). Targeted levels were reached by the next cycle of Testopel® therapy. This represents the first time such a close correlation between a predicted and a measured serum testosterone has been shown using any assay. Because of the accuracy of the model, the authors recommend using it to provide a quantitative approach to the initiation and maintenance of Testopel® therapy instead of the traditional, more qualitative trial-and-error technique. Clinicians can now target average, peak, and trough testosterone levels and we can reach those levels by the second cycle of therapy. It is likely the model can be extended to aid treatment with implantable testosterone pellets other than Testopel®. This paper presents a detailed analysis of our pharmacokinetic model and its usage as a clinical aid. VL - 6 IS - 2 ER -
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