E-Articles - Health and Fitness

Have you ever had one of those days that you just don’t feel like doing anything? It’s like you really woke up on

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

the wrong side of the bed. Nothing seems to be going right, your energy level is down and your state of mind is

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

Examples of combination products may in

a little ragged...

Let me tell you... yesterday was like that for me.

It was extremely rough as I felt depresse

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

d for some reason I can’t explain. I just couldn’t shake it (which is VERY uncharacteristic of me). The whole day

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

felt like everything was piling on top of me. And, granted, I could have just gotten in bed at 7′oclock and

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

Combination pro

tried to sleep the day off.

But, I know how I generally feel afterward if I work out. Believe me, I really didn

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

’t want to do it but I made myself follow the 10 minute run (exercise for at least 10 minutes, after that, you ca

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

n quit if you want to). Well, I ended up working out for an hour (much of it at a lower intensity than normal), a

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

d ended up feeling a little better, although not like a million bucks (more like 10).

The reason I am sharing th

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

is is because we all have bad days. Things happen, the day sucks, whatever….

Your entire goal should be to reall

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

y concentrate on the things you can control (like getting exercise) and to understand that the things you can’t c

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

Following aspects would a

ontrol are going to happen, but they aren’t going to get in the way of your progress.

Think of it as running up

dd to the challenges in developing combination products:

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

hill while someone keeps rolling boulders down the hill. Yes, sometimes you’ll need to sidestep, but as long as

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

you keep moving forward, you’ll get to the top eventually.

Even if you are having a bad day, make sure to still

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

try to improve. After all, if you can do it on a bad day, it makes it that much easier on a good day.

Br

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

eaking Through

There is an important concept that you need to understand. It is the concept of breaking

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

Professional from academic institutions, pharmaceutical industries, health care indust

through. You see, many things don’t necessarily ease into existence, they burst into existence. Think of a dam ex

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

ploding.

If you keep focusing on improving yourself every day, you’ll have a breakthrough. It may seem like you

.

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

are doing a lot of “grunt work” but these things build up.

Always keep fighting the good fight, pushing yourself

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

Companies that provide selfless information through particip

, and focusing on improving on a daily basis. Don’t give up…remember, your breakthrough is just around the corner

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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