Your Space - Health and Fitness

Overweight, as we all know, could lead to less mobility, heart problems, and an assortment of various other illnesses, some e

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

ven life threatening. But, how many of us have realized that obesity could actually affect one’s fertility as well?

Accordin

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

Examples of combination products may in

g to a recent study performed by the National Institute of Environmental Health Sciences, fertility and obesity or fatness ar

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

e inextricably intertwined. The research has concluded that men with high BMI (body mass index) have a greater likelihood to

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

become infertile than somebody with normal body-weight. As per the words of head of research, Mr. Markku Sallmen, on a quanti

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

Combination pro

tative level, for every 20 pounds of excess weight a human gains, he/she actually aggravates the chances for infertility by a

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

s much as 10 percent. Another member of the research team – Ms. Dona Baird - adds that overweight has an equal impact on fema

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

le fertility as well, with fatter ladies having a more harder time becoming pregnant than their healthy counterparts. So, bot

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

h the sexes watch out!

Other observations made by the study, now been published in the journal Epidemiology, include the fin

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

ding that male BMI is an independent risk factor for infertility, like the side effects of activities such as cigarette smoki

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

ng, alcohol abuse, or exposure to dangerous chemicals, and an apparent two-fold increase in the chances for obese persons to

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

Following aspects would a

become infertile as opposed to healthy adults.

On the flip side, one apparent pitfall, if to point out, in the study is that

dd to the challenges in developing combination products:

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

the research team had failed to observe if there is any underlying link between obesity and the frequency of sexual intercou

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

rse, which in some sense can be directly associated with pregnancy and hence fertility. Based on the observations made in the

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

research, even though it is possible to conclude that obese men tend to have lesser sexual intercourse than an average healt

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

hy male, some studies published recently overrides this theory stating that such a pattern owes much to the lesser semen prod

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

Professional from academic institutions, pharmaceutical industries, health care indust

uction in obese people and it is very remotely linked with the frequency of intercourse.

So, for the gluttonous lot out ther

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

e, what is the immediate solution available? Well, there are not many, but to reduce weight as early as possible. If the obes

.

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

ity is due to hormonal issues, get it treated quickly. For others, cut back on food. Avoid all sorts of junk and oily food it

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

Companies that provide selfless information through particip

ems, sweets, and victuals rich in fat. Exercise regularly and have lots of water daily. After all, health is wealth. Isn’t it

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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