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Want To Catch More Fish At Night, Watch the Moon!

Sounds like a crazy idea, doe

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

sn't it?

I thought so to, until I experienced it first hand.

Using the moon, y

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

Examples of combination products may in

u are able to learn several things about fish at night. During a full moon, you

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

are most likely to find fish hiding in the shadows. Don't ask why it's true, b

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

t that's what we have seen. When you find shadows on the water (from trees, etc

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

Combination pro

, you know exactly where you need to cast your line.

If the moonlight is not sh

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

ining down on the water and there are no shadows, the fish will be much more sca

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

tered in the water, making your job of finding them much more difficult.

On the

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

other side of the coin, it seems like the fish are more likely to hit when the m

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

oon is hidden, either by clouds or a quarter moon. So, the real trick is to use

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

the moon to determine how you are going to fish that particular night.

If you h

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

Following aspects would a

ve a bright, full moon, head for the shadows on the water. If you are on the wa

dd to the challenges in developing combination products:

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

ter and the moon is nowhere in sight, you can go straight to your favorite spot

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

nd fish like you normally do, but expect to get more frequent and harder hits on

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

your line.

This tip is especially true for bass, but it works with virtually an

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

y kind of fish at night.

Some fishermen swear they only fish during a full moon

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

Professional from academic institutions, pharmaceutical industries, health care indust

others say no moonlight is best. I say, both are best, you just have to alter

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

our style depending on how much moonlight you have that night.

Try it out for y

.

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

ourself and see if you get the same results. This one tip alone has helped me c

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

Companies that provide selfless information through particip

tch some of the biggest fish in my life. Hopefully it will help you do the same

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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