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The finger pulse oximeter detects and assesses changes in oxygen saturation in a record time. Pulse oximete

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

r readings must be accompanied by the percentage of oxygen the person is breathing, and their respiratory r

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ate, for the results to be meaningful.

Blood carries oxygen in two forms, the majority is bound to hemoglo

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

bin (oxyhemoglobin) and the rest is dissolved in the aqueous phase of blood (the plasma). The finger pulse

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

oximeter measures the saturation of hemoglobin with oxygen. This is expressed as a percent saturation in wh

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ich each gram of normal hemoglobin can hold 1.34 milliliters of oxygen.

The dissolved fraction is dependen

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

t upon the partial pressure of oxygen. Under normal conditions each 100-ml of blood contains about 20 ml of

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

oxygen bound to hemoglobin and about 0.3 ml dissolved in plasma. The dissolved fraction is available to tis

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

sues first, and then the fraction bound to hemoglobin. So as tissues metabolize oxygen or if oxygen becomes

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

difficult to pick up through the lungs the dissolved oxygen and the hemoglobin - bound oxygen will eventua

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

lly become depleted. The finger pulse oximeter waits to sense the pulse of capillary blood from side of the

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

capillaries, then using two different wavelengths of light calculates the percent of oxyhemoglobin from th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e total hemoglobin present. If oxygen transfer across the lungs or lung function is compromised and as tiss

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ues continue to metabolize oxygen, the percentage of oxyhemoglobin will decrease.

The pulse oximeter readi

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

g becomes the quantitative indicator of hypoxia. Pulse oximeter reading may be quantified as mild to modera

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

te hypoxia if presented by a pulse of 90-95%. Moderate to severe hypoxia is represented by a pulse of 80-90

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

%. Severe hypoxia is anything less then 80%, although the accuracy of pulse oximetry decreases generally be

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

low about 70%.

The primary utilities of the finger pulse oximeter are to determine the relative severity o

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

f cardiopulmonary or airway disease, monitor the effectiveness of therapy and monitor for deterioration in

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

condition. Abnormal hemoglobin saturation is more useful to guide the physician in clinical decision making

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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