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MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Date:8/19/2007

le insulin, is likely to have greater impact on outcomes and become the preferred means for delivering insulin for Type 2 diabetics.

The first inhalable insulin product, Pfizer's EXUBERA(R), was approved by the European Commission on January 26th 2006 and by the FDA on January 27th 2006. Following the launch of EXUBERA(R) inhaled insulin has become available for diabetics and the way is being paved for next generation products.

About Glucose Clamp Technique

Glucose clamp technique is a technique that maintains a constant blood glucose level in human subjects by perfusion or infusion with glucose; the technique is used in studies to obtain evidence of the effectiveness and bioavailability of preparations of insulin in healthy human volunteers, and patients who suffer from diabetes.

Glucose clamp techniques represent the gold standard for pharmacodynamic and pharmacokinetic studies to describe the time-action profiles of glucose-lowering drugs; the effects of these drugs administered by various routes of administration can be studied individually, and then compared. For example, the effects of inhaled versus subcutaneous insulin.

The European regulatory authority EMEA expressly refers to the glucose clamp technique in an EMEA/ CPMP Note for Guidance.


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SOURCE MicroDose Technologies, Inc.

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