Suggest - Relationships

Is your relationship becoming uncomfortable? Are you no longer enjoying the relationship? Do

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

you not understand what might be going wrong, but you can sense it? You are not happy, but ca

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

Examples of combination products may in

not pin point the cause of unhappiness. You want to get away from the relationship but are ar

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

guing for and against and getting tired of the whole thing. This is a typical; sign of gettin

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

crushed and facing confusion in the relationship. Let us discuss more about how this happe

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

Combination pro

s.

I will give one example- your partner is with you. Your partner is not contributing any p

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

ositives to the relationship. She/he keeps complaining that you are the cause of their unhapp

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

ness and discomfort. You wonder how when the ball is in the other court? She/he does not unde

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

stand what ever you are trying to communicate. You get angry and try to explain again only to

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

get further frustrated. If you talk of separation you are told that they will not be able to

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

live alone. They want to be with you. Get all the comforts from you. They care nothing about

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

Following aspects would a

our comfort. They blame you for everything that goes wrong. They understand no communication

dd to the challenges in developing combination products:

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

or act as if they don't understand. You want to run away from it all, but they make you feel

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

uilty of doing something terribly wrong by that. You simply do not know what to do and are at

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

your wits end. You feel crushed.

What should you do in this situation? Let me tell you. Don'

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

t interact with your partner. Don’t try to communicate at all. Ask them to take care of thems

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

Professional from academic institutions, pharmaceutical industries, health care indust

lves and not to bother about you at all. Get away slowly by taking no obligation from them. L

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

t them feel it slowly. Over a period of time they will understand that they cannot manipulate

.

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

you. If at that point, you separate, they will not be able to play their game of making you

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

Companies that provide selfless information through particip

eel guilty. You will get your freedom. Reclaim your freedom from relationships that crush you

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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This simple change in philosophy could turn your business around. Question is... are you willing to do it?

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