Summary - Relationships

Lot of discussion takes place about the difference between friendship and mar

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

riage. Two good friends marry at times. But what about married partners, do t

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

Examples of combination products may in

ey become good friends? What are the qualities of friendship that are not fou

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

d in a marriage ideally every married couple should be best friend of each ot

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

er. They should share all their secrets, their problems, their laughter and t

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

Combination pro

eir joy with each other. There is one vital difference between friendship and

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

marriage. A marriage is a legal binding and breaking a marriage takes much m

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

re than a friendship.

This is the reason that most of us are unguarded about

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

our friendships. There is not much at risk. In marriage the risk is very high

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

Therefore if the relationship gets little strained, the partners get worried

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

and try to find ways out of the crack.

How about becoming best friends with

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

Following aspects would a

each other? Should a married couple not develop that relationship? It should.

dd to the challenges in developing combination products:

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

Are you and your spouse best friends? Are you very much for each other at all

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

the times? What about openness in relationship? Are you totally honest with e

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

ch other? Let me ask you a question. Say, you find a great looking person of

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

pposite sex and you get attracted. Will you talk about that with your spouse?

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

Professional from academic institutions, pharmaceutical industries, health care indust

You would not hesitate doing that with your friend. Am I correct? How about

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

haring this with your spouse? Most of us will never do that. We keep a corner

.

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

in our heart that is walled from our spouse. We need to break that wall. We n

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

Companies that provide selfless information through particip

ed to develop very open relationship with our spouse. Try it you will love it

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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Summary - Quiz - Are You And Your Spouse Best Friends?

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