Advice Pool - Health and Fitness

Chicago, Illinois. December 8, 2006. An 8-year German study showed a direct relations

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

hip between abdominal weight and women’s diabetes risk. The study, involving over 2,0

; 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 participants, found that it wasn’t so much how much fat you have on your body. It’

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

s a matter of where that fat resides.

Published in the American Journal of Clinical N

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

utrition, the study determined that women with a waist size of 35” or more were at a h

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

Combination pro

gher risk of diabetes, compared to their skinnier counterparts. And women with waist

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 of 39” or greater suffered from insulin resistance, 10x’s more likely to have a diab

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

etic condition, compared to thinner study participants.

Unfortunately, women’s stomac

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

h fat has been increasing over the last 40 years, with mean waist circumference growin

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

g from 32” in the mid-1960s to 37” today. This puts about 60% of adult American women

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

n the ‘at risk’ category.

“It’s becoming clearer and clearer that body fat distributi

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

Following aspects would a

on is an important variable”, says Harvard’s Chief of Preventive Medicine JoAnn Manson

dd to the challenges in developing combination products:

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

. “And abdominal fat is the key culprit.” Excess stomach fat wraps itself around inte

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

rnal organs and secretes a powerful body chemical. This is turn, set off reactions tha

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

t can lead to diabetes.

Abdominal or visceral fat, while a good indicator of diabetes

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

risk, is often overlooked by doctors as a symptom to be watched. According to another

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

Professional from academic institutions, pharmaceutical industries, health care indust

study, 71% of women have never had their waist circumference measured by their doctor

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

s.

Most health officials recommend that waist sizes for women should be 31.5” or less

.

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

. Study reviewers say the results of this excess stomach fat study are a “call to ac

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

Companies that provide selfless information through particip

tion for all women to undergo risk factor screening, including waist size measurement.

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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