Summary - Relationships

This sounds a different kind of title - Do You Understand your Lover? Doesn’t everybody do? Sadly

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

not many of us understand our partners fully. If we had understood our lovers, the rates of sepa

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

Examples of combination products may in

rations and divorces would have gone down substantially instead of increasing. You may ask- if I

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

don't understand my lover than how are we so good partners? Why he/she enjoys me? Why are we toge

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

ther? Let me talk about these.

What does it mean by understanding? It is again a difficult quest

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

Combination pro

on. Knowing about likes and dislikes does not mean understanding. To understand means to know the

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

values, the life goals and the priorities of a person. To understand means to know what incidenc

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

es made what impacts on that person. To understand means - you will be able to predict the reacti

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

on of your partner at a crucial moment. Can you do that with surety?

In the beginning of our rel

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

ationship, we all talk about good things of life. Our focus is more to please our partner. Our fo

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

us is to get more pleasure in their company. we never think about the underlying psychological mo

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

Following aspects would a

tivators at that time. After the relationship develop little further, we find that many times we

dd to the challenges in developing combination products:

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

get baffled by what our partner says and vice-versa. That side of his/her character we never kne

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

w. If this is something, we can accept easily, we will forget about it, or fissures will develop

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

at this juncture.

Not many partners are totally honest with each other about their deepest thoug

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

ts, desires and fears. If I fear that you may one day leave me, because I doubt your long term lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

yalty, will I ever tell you about that fear? Such hidden thoughts create a wall between the partn

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

ers that can be never crossed. Only few manage to break it. Once you do that and tell everything

.

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

about yourself and your thoughts and get to know everything about your partner, the relationship

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

Companies that provide selfless information through particip

will grow stronger. These kinds of relationships were common in the earlier days but are rare now

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 - Do You Understand Your Lover?

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