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If you want to change (something) you will have to search first for

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

“constructions”.

A construction is something that is fixed, lasting

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

Examples of combination products may in

and constant. A building is an example of such a construction. But t

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

ere are more examples. The structure of your organization is also fi

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

ed. Then there is the juridical form of the company and most of all,

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

Combination pro

but less visible are the contracts.

If you would categorize the con

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

tructions in order of “hardness” the structure of the organization i

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

softer than a (employee) contract. Under normal circumstances you a

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

e not aware of this, but it becomes clear with reorganizations and w

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

en you have to deal with resignations.

When preparing for a change

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

ou should examine these constructions in order to find out where the

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

Following aspects would a

e is space to increase flexibility. You should ask what construction

dd to the challenges in developing combination products:

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

can be modified or even torn down.

With the constructions you will

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

find the real information. It is like the DNA of our body. The real

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

haracteristics show up when you observe only the constructions. Much

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

of the style depends on this form. You can “ask” the employees in a

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

Professional from academic institutions, pharmaceutical industries, health care indust

actory to be more client oriented, but their main focus remains to p

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

oduce. It is in the characteristic.

Changes against these character

.

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

stic will never survive. When this is clear and accepted you can us

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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