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Anemia is a deficiency of the red blood cells required by the

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

body to carry hemoglobin. Hemoglobin is necessary because it carries

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

Examples of combination products may in

oxygen through the blood into all parts of the body keeping it alive.

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

Hemoglobin levels should be higher than 15 grams or it is considered

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

too low.

Low levels of red blood cells are quite common among premat

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

Combination pro

re babies, and many times preemies require a transfusion of red blood

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

cells, especially premature babies under 1,000 grams. There are a ma

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

ny reasons why a premature baby may develop anemia. First of all, dur

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

ng the first few weeks of life premature babies’ bodies do not make m

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

any new red blood cells, and the red blood cells their bodies do have

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

do not last as long as older children.

Blood loss is another reason

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

Following aspects would a

that a premature baby can become anemic. Premature babies can have bl

dd to the challenges in developing combination products:

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

eeding problems that can increase their risk of developing anemia, an

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

one serious problem is Intraventricular Hemorrhage (IVH). A prematur

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

e baby can also develop anemia if her blood is drawn too frequently.

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

Studies are being done on iron supplements for premature babies, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

how they will be administered if they are found to be effective. Righ

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

t now transfusions are the best and safest way to increase the iron i

.

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

your premature baby's blood. Symptoms of anemia (low iron in the blo

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

Companies that provide selfless information through particip

od) are pale skin, lethargy, poor feeding, tackypnea, and tackycardia

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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