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There is a genetic abnormality that affects only males, called Klinefelter's syndrome. Its name comes

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

from the name of the American physician, Harry Klinefelter, and is a disorder that affects practically 1 in 10

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

Examples of combination products may in

00 men. So it can be said that Klinefelter's syndrome is rather a common genetic abnormality that occurs in many men.

Th

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

sex of a human being is basically determined by the chromosomes in the body. In the case of a male, he has one X and one

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

Y chromosome, and in the case of women, they have two XX chromosomes. In the case of men with Klinefelter's syndrome, th

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

Combination pro

ey have an extra X chromosome (XXY) in their genetic material. However, men can never ever tell that they have an additio

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

al chromosome.

There is no specific cause for the occurrence of Klinefelter's syndrome; however, it has been found that

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

women who have boys after the age of 35 usually have sons having a higher incidence of Klinefelter's syndrome. The main a

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

nd most important sign of Klinefelter's syndrome is infertility and it is basically this symptom that makes the

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

an aware that he suffers from Klinefelter's syndrome.

The biggest drawback about men suffering from Klinefelter's syndro

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

me is that they cannot actually produce any sperms in themselves. This is the reason such men usually cannot fat

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

Following aspects would a

her a child.

All the other symptoms of Klinefelter's syndrome is that these men usually have enlarged breasts and small

dd to the challenges in developing combination products:

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

nd firm testicles. These men seem to have abnormal body proportions where they have long legs and a short trunk along w

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

ith a small penis. It has also been found out that men with Klinefelter's syndrome tends to have little facial a

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

nd body hair.

A man can be diagnosed for Klinefelter's syndrome through some genetic tests. With these genetic tests the

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

man gets to know of the presence of an extra X chromosome in their body. It is usually during adolescence that a man is i

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

Professional from academic institutions, pharmaceutical industries, health care indust

dentified with Klinefelter's syndrome. This is because some research will be done on the boy, when there is not the right

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

form of teenage development in the boy.

When diagnosed with Klinefelter's syndrome, it is possible to undergo testoster

.

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

ne therapy to improve the sex drive, to increase overall muscle strength of the male and to promote hair growth in the ma

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

Companies that provide selfless information through particip

n. However, most men suffering from Klinefelter's syndrome are not able to father a child even after testosterone therapy

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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