E-Articles - Health and Fitness

Yes I have been there as well, and I am still a sufferer, just on a lesser scale. You are probably reading this article because you ha

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

ve these symptoms or you know of someone that does for whom you care about. Its a long road let me tell you, If you had asked me 6 mon

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

Examples of combination products may in

ths ago if I had suffered from anxiety(I mean really bad anxiety) I would probably have looked at you funny! It can really creep up on

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

you.

Now lets talk about how things can change seemingly so quick. You may be able to relate to these. Driving to work at 7 a.m. wor

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

king all day not knowing when you're day will end, maybe you will work 8, 9 or even 10 hours today. Having your boss or bosses breathi

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

Combination pro

ng down your neck about when you will be done with a particular project. Then the end of the day finally arrives and you need to rush

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

to complete the required tasks for the day. So you have won the daily battle at work and know it is time to tackle rush hour traffic!

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

boy I can't wait just when I thought I was home free!

I am sure a lot of you can relate to this type of work routine and most will ha

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

ve no problem with this, but sooner or later some of us just can't do it and it will eventually catch up to us, as it did with me.

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 won't even realize it because it is so gradual, and then boom it will hit you like a freight train. I had no idea what was happening

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

to me. Was I going to die? was I having a heart attack? No but I did develop panic attacks caused by excessive work related stress an

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

Following aspects would a

d anxiety.

Your body will send you signs that there are going to be attacks if something doesn't change and here is what symptoms I w

dd to the challenges in developing combination products:

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

as having so listen up. Now I have left my last job about 6 months ago and when I look back at how I felt(I mean from a physical stand

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

point) I can tell you I was very irritable, my skin became very itchy and I was very sensitive to light and sounds. Perhaps you can re

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

late to this as well.

So this was my body trying to tell me that something is wrong. This is referred to as the Fight or Flight state

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

that is in all of us. It is very similar to when you would be face to face with a giant bear on his hind legs roaring at you as he is

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

Professional from academic institutions, pharmaceutical industries, health care indust

about to have you for lunch! You see your body really doesn't know the difference, it has the same effect from a physical standpoint.

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

I would like to close by saying that I do not wish to scare anybody with this information but to only make those aware of what is po

.

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

ssible if you are feeling extremely stressed out with high anxiety. If you are feeling any of these symptoms I have talked about here,

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

Companies that provide selfless information through particip

you may be headed for panic-disorder, just keep this in mind and try to change your current environment/situation whatever it may be.

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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