IDS technology receives FDA approval
Administration (FDA) approval for over-the-counter use of the
company's insulin dosing technology in clinical trials.
The Intelligent Dosing System (IDS) uses the patient as his or her own control, individualising the dosage based on patient response to dosing. The FDA has cleared the IDS as a class II medical device.
The three-part software suite of the IDS is comprised of DoseRx, a 'next' dose calculator; Interchange Rx, used to switch a patient from one agent, brand or class of drug, to another; and Practice Prescribe Rx, a graded prescriber training simulator for new or infrequently used drugs.
John McMichael, CEO of Dimensional Dosing Systems, told In-Pharmatechnologist.com: "Currently most systems only use empirical dosing sort of one-size fits all approach. The IDS system individualises doses to fit patient needs and goals."
An accurate automated drug-dosing program confers many advantages including minimising the learning curve for the physician prescribing the drug, particularly for drugs with large pharmacokinetic variability and a narrow therapeutic index.
It also improves patient care by reducing toxicity and decreasing the length of hospital stay experienced by patients, resulting in a cost-benefit advantage.
The IDS requires only two prior dose and response inputs to calculate the optimal next dose and is effective in the simultaneous dosing of multiple agents. It therefore makes the system suitable for physicians and/or patients, whoever can best utilise the technology.
Using its proprietary dose-response technology, the IDS draws a correlation between the patient's previous dose and response; the current dose and response; and a desired response to provide the next dose required to achieve the desired surrogate marker. Specifically, the IDS recommends the next dose necessary to reach a desired marker with an accuracy of 90 per cent to 97 per cent.
The technology is currently entering clinical trials for dosing insulin. McMichael said that hoped that the company could sell subscriptions to physicians for $179 (€139 a year).
"With the most recent approval for OTC dosing insulin this price will be drastically reduced to meet patient needs," he commented.
McMichael also stated that in addition, the company was confident the IDS could be utilised in dosing regimes for cancer therapeutics and anti-coagulants as well as antibiotics and pain medications.
Currently there are no similar response dosing technologies on the market today. Most systems have their roots in pharmacokinetics.