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Several university studies have determined that using oxygen concentrators are a valuable tool for treating children with hypoxemia in developing

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

countries. The World Health Organization (WHO) also recommends supplying oxygen to children in developing with oxygen concentrators. The WHO pref

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

Examples of combination products may in

ers oxygen concentrators to compressed oxygen cylinders because cylinders pose significant cost and logistic problems.

Hypoxemia is a common comp

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

lication of acute lower respiratory tract infections in children. The disease is an abnormal deficiency in the concentration of oxygen in arteria

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

l blood. When people think of health problems for children in developing countries, they rarely think about respiratory illness. Pneumonia alone

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

Combination pro

contributes to between 750,000 and 1.2 million neonatal deaths and an undetermined number of stillbirths each year worldwide. The majority of dea

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

ths from pneumonia occur in developing countries, where facilities for early detection are few and far between. Finding oxygen therapy equipment

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

is a challenge throughout the third world.

For children with hypoxemia in developing countries, early detection and treatment is the key to survi

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

val. Here are some of the most common warning signs associated with hypoxemia:

* Rapid breathing (more than 60 breaths per minute)

* Nasal flar

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

ing

* Grunting

* Head nodding

* General depression

* Lethargy

The combination of several of these physical signs can be used to predict hypox

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

mia in children with acute respiratory infection (ARI) with reasonable accuracy. Healthcare workers and parents can be taught these warning s sig

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

Following aspects would a

ns to help aid in early diagnosis.

Unfortunately, oxygen therapy is not part of the first line of treatment for most children with ARI in develop

dd to the challenges in developing combination products:

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

ing countries. Oxygen in these poor countries tends to be given to already seriously ill children, often with poor results. Oxygen can be much m

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

ore useful if given at earlier stages of respiratory disease. Studies indicate that oxygen concentrators may improve management of childhood asth

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

ma in developing countries and are more cost-effective than conventional compressed oxygen cylinders. The only requirement for oxygen concentrato

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

s is a reliable source of electricity. Even this can be overcome with a small generator or a portable oxygen concentrator with re-chargeable batt

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

Professional from academic institutions, pharmaceutical industries, health care indust

eries.

Oxygen concentrators are currently being successfully used in district hospitals in Egypt, Mongolia, Papua New Guinea and Malawi. Researc

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

h by the WHO has determined that one oxygen concentrator can provide low flow oxygen to up to 4 children. The organization also believes that sav

.

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

ings offered by oxygen concentrators could be used to purchase other essential medicines and supplies. Charity organizations would be wise to pur

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

Companies that provide selfless information through particip

chase oxygen concentrators for children in developing countries. Oxygen concentrators provide life saving oxygen while offering exceptional value

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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