E-Articles - Health and Fitness

Recently, a study conducted at the Boston University Medical School concl

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

uded that a very small genetic change in DNA area is the leading cause of

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

Examples of combination products may in

obese propensity. The incriminated gene, its name is INSIG2, plays a str

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

tegic role in fat production and makes somebody more prone to be obese by

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

simply changing its normal G-status into C-status (the DNA code is made

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

Combination pro

p of four letters)

The conclusion is blaming people for their obesity is

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

a bit like blaming people for being bold or short.

I personally think t

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

he research team finding is real, but I also see a hidden danger in this

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

pproach. The danger is to accept unconditionally the fact that despite ou

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

r effort, there is no way to control our weight . The consequence might b

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

something like "don't waist your time trying to loose your, it is geneti

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

Following aspects would a

c anyways". Accepting this irreversible role of genetic is like consideri

dd to the challenges in developing combination products:

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

ng obesity and obesity related disease as our normal situation.

The trut

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

is that folks do not become overweight while the amount of food calories

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

is completely used by its body when performing a physical and intellectu

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

l activity. It's also a fact some people are genetically prone to be slim

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Of course, for this very lucky people staying thin is much easier than

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

for people having a genetic propensity for obesity. But I know that a g

.

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

netic predisposition to something isn't a given that it will happen to yo

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

Companies that provide selfless information through particip

u in any condition, it just means you may have to work harder to avoid 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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