Summary - Relationships

Most of us do not care much about friendship except casual meeting,

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

holidaying together or common celebrations. But when a person goes

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

Examples of combination products may in

through bad times, a friend helps like god. He/she may not help wit

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

money but sometimes the situation is so bad that it becomes diffic

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

lt to have someone who will hear about what we go through. A friend

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

Combination pro

helps at such a crucial time. Let us talk more about this.

When we

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

go through a bad patch in life sometimes the phase is over quickly.

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

But sometimes the bad patch stretches so long that we lose the abil

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

ty to fight and develop suicidal tendencies. The fight goes away ou

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

of us and we feel nothing but total depression and helpless. We lo

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

e faith in everybody including us and become afraid about what more

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

Following aspects would a

can happen. That time we need a friend. Talking to a friend sin suc

dd to the challenges in developing combination products:

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

a situation makes us feel that we are not alone. Secondly a friend

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

reminds us about our abilities. The friend who is not directly affe

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

ted can still look at the picture in whole and suggest solutions. T

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

e value of a friend at such time is much more than any treasure.

T

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

Professional from academic institutions, pharmaceutical industries, health care indust

ose who have no body to talk to during their bad period are tremend

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

usly unlucky. Friendship should be formed thinking about such times

.

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

and if our friends anytime need us during their bad phase we should

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

Companies that provide selfless information through particip

immediately offer all support. Unless we give, we shall not receive

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 - Friendship - When Times Are Bad A Friend Is Like God

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