Your Space - Relationships

“How romantic, I wish I too have such a lover, such a relationship”.

Most of us are fascinated by the love affairs of others. We expect a relationsh

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

ip to be filled with love and passion. We often feel that in a relationship the couples will be holding hands and spending the whole day looking into

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

Examples of combination products may in

the eyes of each other. No fights, no arguments and only love, just perfect for each other. We too desire such a relationship, something what we see

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

outwardly. Are we being realistic? No, it is the public image of a relationship. There is a lot of hard work put in that relationship to keep it hap

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

py and strong.

In the beginning of a relationship every thing seems to be rosy and sweet. Everything goes well and in a smooth way. You are happy wi

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

Combination pro

th each other and in deep love. You find your world to be bliss. There is romance and love. With the passage of time all that love and romance vanish

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

es away and you are left with conflicts, arguments and bitterness. You are disappointed. The reason behind it is our unrealistic expectations.

Your

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

lover is not a superhero do not expect him to get moon from the sky neither your lover is a superwoman don’t expect her to be a magician. None of us

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

are perfect. All of us have some faults and defects in us. We should learn to accept people with their faults and respect for what they are.

Wheneve

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

r we get into a relationship we have great expectations from each other. We look out for all we thought and expected from our partners. Mostly we fac

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

e disappointments as we expect too much from our partners and are unrealistic in our expectations. This often leads to a split in a relationship. Do

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

Following aspects would a

not expect your man to hold your and keep loving you all day he has to go to work. Do not expect your woman to be working all day in the house she ha

dd to the challenges in developing combination products:

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

s her career to pursue. You have to be realistic in your approach and not live completely in a romantic world.

After you have a child your life beco

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

mes more demanding. You have added responsibilities. To have the same expectations of life filled with love and romance as during courtship is unreal

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

istic when you become parents. There are more responsibilities to be filled in less time. You cannot avoid the work and time to be spent after your c

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

hildren. This automatically means spending less time with your spouse and less of romance. You should not be disappointed but be practical and whenev

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

Professional from academic institutions, pharmaceutical industries, health care indust

er possible take out time for each other.

You should learn to understand your partner and know him/her well. You should be aware of the shortcomings

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

of your partner. You should know the drawbacks of your partner. Do not expect him or her to that which you know is not possible for your mate.

You

.

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

should learn to separate romance from reality. This does not mean that there should be no place for romance in a relationship but that you should als

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

Companies that provide selfless information through particip

o learn to be a realistic. Never ignore the reality and come out from your world of dreams. High and unrealistic expectations lead to disappointment.

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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Your Space - Relationship: Realistic Expectations

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