E-Articles - Relationships

Every relationship involves two people. Both try to wok on the relationship t

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

o make it a success. They do things for each other and try to make each other

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

Examples of combination products may in

happy. In some relationships, they may not have married, but except the forma

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 certificate they live together and behave exactly like a married couple. As

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

I said, for a relationship to succeed two people have to work. The same is tr

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

Combination pro

e of married relationship. Suppose this relationship begins going downhill be

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

cause the partners refuse to acknowledge each other’s contribution.

This can

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

also happen from one side. One partner can try his/her best to work on the re

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

ationship but gets no pat on the back from the other. It may be true with the

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

other partner. As if both are working without being aware of the existence o

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

the other. Why do they live together and why does this situation arise?

Whe

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

Following aspects would a

partners make wrong selections, they end up with such problems. They don't w

dd to the challenges in developing combination products:

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

ant to come to terms with the fact that the relationship has failed. They con

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

inue working together hoping for a miracle to occur. That will never happen.

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

iving together in the hope that situation will improve and will be same as it

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

was earlier is dangerous. It takes time and life away slowly. Better to talk

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

Professional from academic institutions, pharmaceutical industries, health care indust

to each other openly about what is happening, and decide either to improve or

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

to separate. Why does such deterioration take place? The primary reason may b

.

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

e that both partners feel that what they had thought about the other partner

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

Companies that provide selfless information through particip

s not true. What they saw written on the packaging is not what the product is

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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E-Articles - Relationships - When It Deteriorates Beyond Repair

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