Advice Pool - Relationships

Do you have someone who can feel the pain in your eyes? Do you have someone wh

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

o can understand the ache of your heart? Do you have someone who can understan

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

Examples of combination products may in

your misery? Do you have someone who can understand your helplessness? Do you

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

have someone who can wipe your tears? Do you have someone who will not ask yo

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

not to cry, but will give you a shoulder to cry upon? Do you have someone who

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

Combination pro

waits for you? Do you have someone who keeps awake with you? Do you have some

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

ne who will talk to people on your behalf? Do you have someone who will feel t

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

he pain of your life? Do you have someone who knows that you don't want to liv

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

, but are forced to live? Do you have a true companion?

I am not talking only

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

about a wife or a husband or a friend or a companion? Anyone it can be. But d

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

you have someone who understands you and who is with you always? If yes, you

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

Following aspects would a

are a very lucky person. God has given you all the luck you wanted. Because ge

dd to the challenges in developing combination products:

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

ting a person like what I talked above is very difficult. You will rather find

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

that during your time of hardships, pains and misery, you are alone. No one w

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

ll understand your actions or motives. They will argue with you. They will sug

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

gest you. But they will not be with you. You will have to face your misery all

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

Professional from academic institutions, pharmaceutical industries, health care indust

alone and on that day, you will cry for someone who understands you.

You will

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

not get that person. Your beating heart may stop with the pain. People will g

.

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

ther to bury you. But no one will help you live, when you wanted. That time yo

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

Companies that provide selfless information through particip

u will probably thank death for getting you away from this world of loneliness

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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Advice Pool - Are You Lucky To Have Somebody Who Understands You?

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