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Some couples can't have children. They simply can't get pregnant. A

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

ttempt after attempt and no results. Of course we all know about fe

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

Examples of combination products may in

male infertility. But we will talk about infertility in men. Infert

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

ility in men occurs in 30% cases when a couple can't get pregnant.

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

The problem of male infertility is in male ejaculation problems and

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

Combination pro

low sperm count. When the man can't properly release semen to get

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

the woman pregnant, he can be suffering from erectile dysfunctions,

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

premature ejaculation.

Low sperm count can be caused by hormonal

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

isorder, infections and by wearing tight underwear. If you have con

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

cerns regarding male infertility, you should see a doctor immediate

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

ly, especially if you tried getting pregnant and failed.

Male infe

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

Following aspects would a

rtility may be treated. 50 percent of male infertility cases can be

dd to the challenges in developing combination products:

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

remedied. Treatment by conventional methods may help the couple get

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

pregnant through normal sexual intercourse. There are medications,

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

antibiotics, and sperm volume pills that a man can take to help in

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

sperm production, get rid of infection, or aid in hormonal imbalan

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

Professional from academic institutions, pharmaceutical industries, health care indust

e. Also, you can try wearing loose clothing like boxers or avoiding

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

hot tubs, saunas, and long hot showers.

But remember: male infert

.

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

ility should be treated as soon as possible! If you don't treat it

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

Companies that provide selfless information through particip

in time then you can forget about your wife's pregnancy.

Good Luck

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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