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“Researchers have found out why Moses kept walking through the desert with the Israelis for 40 years: A man never

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

asks for directions.” ~ Anon

How many roads must a man go down before he will stop and ask directions?!? ~ Mich

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

Examples of combination products may in

lle Argabrite

This is as old as good old Moses. Indeed, if we don’t want to go around in circles, we might as we

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

l have a good map handy, not that we really know how to read it anyway, so we better study it ahead of time. We m

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

st accept the fact that he will keep trying several routes to find his way when he is lost.

Yes, it is annoying

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

Combination pro

hat he won’t stop and ask for directions, but quarrelling and yelling won’t solve the problem. To him, accepting

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

he reality of such defeat is a sign of weakness and he doesn’t like that a bit. On the other hand, we also sin, f

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

or the truth of the matter is that most women have a hard time reading maps; we also have a terrible sense of dir

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

ction. I am one of them: it took me almost 6 months to learn that I needed to turn right and not left on a certai

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

road when going to my piano teacher’s studio.

A typical illustration of this characteristic is a “The Far Side”

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

cartoon showing a couple driving a car on another planet. The man is at the wheel trying to read a map and she sa

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

Following aspects would a

s something in the lines of: “Why don’t you ever ask for directions?”

I once read about this one British guy who

dd to the challenges in developing combination products:

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

became a millionaire when he printed maps upside down as well as the regular way. It was a hit among women.

Now,

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

since we are speaking of directions, men also can’t give good ones even if their lives depended on it. Have you n

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

oticed that when a man gives you directions you get lost more easily? They have not heard of the concept of landm

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

rks, traffic lights, stop signs, and so on. It is really aggravating and we only notice it when we are already lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

t.

A Word of Advice:

Ladies: Study any unknown route before leaving home and leave early. Never trust a man to

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

elp you find your way, unless you remember to ask for landmarks, though I doubt he will remember any. Get driving

.

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

directions from women, if they had traveled that route before, or, better yet, get them from the Internet.

Gents

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

Companies that provide selfless information through particip

Have a good map handy, always, or buy a car with a navigational computer. It is also ok to stop and read the map

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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