Advice Pool - Health and Fitness

People say ‘everything in moderation’. And that’s fine for people that have a clear conception of what moder

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

ation is. The book definition of the word basically sums it up as: The avoidance of extremes in opinion, fee

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

Examples of combination products may in

ings or personal conduct. But knowing what the word means, and practicing the action, aren’t always one in t

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 same for a lot people. Because as the definition states – it’s the avoidance of extreme behavior, and when

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

it comes to taking drugs and/or over-indulging in alcohol, the word moderation doesn’t exist in their vocabu

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

Combination pro

lary, or their world for that matter.

People also say “too much of ‘good’ thing can be bad”. Now for those

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

ho know someone struggling with drug or alcohol dependency, or if you are besieged with this problem yoursel

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

, you know that clich? couldn’t be more true.

A continued and extended drug addiction and/or alcoholism wil

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

eventually shut a person’s body down. Millions of people die every year from drug and alcohol-related illne

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

sses – and it is not a ‘pretty’ way to go either. A corroding liver, brain hemorrhage, massive heart attack

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

do these things sound like fun?

And it’s not just the body that is soured by the effects of drugs and alco

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

Following aspects would a

ol; it’s the mind as well. The obsession with getting high and/or getting drunk can drive most people over t

dd to the challenges in developing combination products:

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

e edge during their addictive state – especially when that addiction isn’t being fed. They’ll lie, cheat, st

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

eal and in some circumstances, even kill to get what they need to feed their habit. It’s a sad, sad way to l

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

ve and what’s even sadder is that the addict, most of the time, has no comprehension, nor do they care, what

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

it’s doing to their family and friends. Everyone suffers, not just the addict.

So, don’t turn into a co-dep

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

Professional from academic institutions, pharmaceutical industries, health care indust

ndent part of the relationship. Giving someone forgiveness that is on the road to recovery is a one thing. B

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

ut doing so over and over while they are still hurting themselves and others simply adds fuel to the fire.

.

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

f you or someone you know has a substance abuse problem, seek treatment. Although most addicts won’t go unti

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

Companies that provide selfless information through particip

they hit rock bottom, and even in some of those cases still refuse, there is hope – there is help available

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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