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Anyone who has crossed over would agree to that. It’s like when we cross over even the most ins

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

ignificant things start niggling us. A small comment or a lame joke usually end up in the uncha

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

Examples of combination products may in

rtered territory. And we usually don’t want to mention that we were offended by something that

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

didn’t feel right to us. You see all the perceptions about grown-ups ‘discussing’ their problem

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 are a farce. We don’t ‘discuss’ anything heavier than the weather.

The things which would’ve

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

Combination pro

been settled down by going for each others throats for a while back in teenage days can not be

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

discussed now. You see after the cross over we all have the same hallucinations; of being smart

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

enough. We don’t discuss It, our solution to all such problems is by default ‘Can’t possibly m

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

ake it, might as well fake it’. It’s our usually our final understanding that since ‘him and yo

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

u’ have been buds for years he should’ve known better. It never occurs to us that all that’s wr

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

ng is that we didn’t get his joke. But we understand that discussing it would no longer mean th

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

Following aspects would a

at we are grown-ups since its imperative for us grown-ups to comprehend everything by ourselves

dd to the challenges in developing combination products:

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

. It happens to all of us, me, and you, and the guy next door.

But all this doesn’t stop us fr

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

om coming to each others aid in difficult times. Because even though our stories had been of fr

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

iendship, trust, deceit, lying, cheating, and treachery. Somewhere between all the lying and ch

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

ating, we’ve had our moments, we have managed to live it up, and that’s what bonds us. We’ve sh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ared the same joys and we’ve shared the same agony. We are a bunch of folks, brought together b

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

y destiny; we have strived and survived together. We’ve nursed bad hangovers together, after ni

.

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

ghts when we forgot our own names. Together we’ve managed to experience a lot in very little ti

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

Companies that provide selfless information through particip

me.

And thats exactly why we are friends and foes, till the next lame joke offends our ass off

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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