E-Articles - Health and Fitness

Recently I was giving a talk and I used the expression, 'fat bloke'.

Following the presentation a woman

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

approached me to let me know that I had offended her with my 'language'. When she told me that 'fat' was

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

Examples of combination products may in

the offensive word, I nearly fell down.

I said: "1. he was a bloke and 2. he was fat....what's offensive

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

"

Then she really hated me.

She told me that my language was "politically incorrect and that my tone wa

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

s inflammatory (whatever that means) and provocative.

And I thought provocative was a mini skirt.

Oh we

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

Combination pro

l. Thanks for the life-lesson grumpy arse.

When I pointed out that I wasn't commenting on the bloke's n

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

ature, character or value to society, I was merely referring to the fact that his obese body (an observat

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

on, not an insult) put him at risk of heart disease, she didn't really get it.

I was still a pig.

I'm s

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

ick of people creating new labels for fat in order to make us all feel better (big, large, full-figured,

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

eavy-boned, thick set) and I'm sick of people dancing around obesity and all it's related issues in an ef

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

fort to be politically correct.

Whatever you do, don't damage anyone's self-esteem... ignore the big fat

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

Following aspects would a

gut and those clogged arteries and hand them another donut.

I don't want to offend people... I want to

dd to the challenges in developing combination products:

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

e HONEST.

Let's call it what it is (fat) and deal with it.

Let's stop fluffing around, let's stop being

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

precious and looking for reasons to get hurt, and let's acknowledge what's really happening in Western

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

ociety:

We're eating ourselves to death.

I do care about people's self-esteem and emotional state... BU

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

T I care more about their cardio-vascular health and whether or not they will be alive next year.

If som

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

Professional from academic institutions, pharmaceutical industries, health care indust

one gets a little offended but I help them live another thirty years (with a leaner, lighter, healthier b

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

ody) then I'm prepared to be blunt (there's a shock).

It is predicted that the next generation will be t

.

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

e first to have a shorter life-span.

Because of obesity, they will die sooner.

"Poor John; he died of a

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

Companies that provide selfless information through particip

heart attack at twenty eight."

"He weighed 400 pounds, but at least his self-esteem was in great shape.

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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