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A -- non business -- example of an intervention is a chirurgical

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

intervention.

Interventions of all kinds are useful when managin

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

Examples of combination products may in

g change. You can call in the help of an Interim manager to speed

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

up change. The shock effect in such a situation is normally enorm

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

ous. And so can be the resistance. The advantage of such an inter

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

Combination pro

ention however is that everybody is aware, there is commitment an

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

d attention. The other side is that when this manager leaves the

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

stage, you risk turning back the previous situation. Like the res

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

tore of a backup.

Another kind of intervention is one that is no

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

visible. You can hardly call it an intervention, because it smoo

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

thes into your organization like a virus.

You will probably be f

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

Following aspects would a

amiliar with it, especially if you are the father or mother of a

dd to the challenges in developing combination products:

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

hild. Kids copy their parents. This can be extremely nasty, beca

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

use when they copy you, you are mirrored your own behavior.

Givi

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

g the right example is a difficult job. And that is what change i

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

s about. It is difficult. Not in setting up all the scenes with n

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

Professional from academic institutions, pharmaceutical industries, health care indust

w job titles, interim management and support from outside. It is

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

difficult because of the fact that you have to take small steps.

.

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

If you are convinced that you have to bend to the left, you shoul

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

Companies that provide selfless information through particip

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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