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Shall I break-up? Am I right? Or my thinking is wrong somewhere? 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

at if I hurt my partner with the break-up? What if I cannot live no

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

Examples of combination products may in

rmally after break-up? Shall I recover from it? Should I break-up?

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

I am having doubts about the reasons. I am doubtful about the cons

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

equences. I am confused. What shall I do?

After life reaches a sta

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

Combination pro

ge where living together becomes very painful, one begins thinking

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

of break-up. But the doubts can be overwhelming sometimes. They can

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

mar the judgment. They confuse the thinking. This makes life furth

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

er trouble some. What is the way out?

The first step should be giv

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

ing your mind little rest. A tense mind tends to lose the way. Rela

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

x and let go of these thoughts for few days. Involve yourself in ot

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

Following aspects would a

her activities. Relaxing your mind will give you some peace and hel

dd to the challenges in developing combination products:

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

p you think well. After you begin feeling peaceful, begin writing d

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

own your reasons for breaking up. Don’t miss anything. Write down a

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

ll the reasons clearly and write explanations wherever needed. This

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

will give you further insight into why you want to break-up.

Plus

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

Professional from academic institutions, pharmaceutical industries, health care indust

es and Minuses - write down both pluses and minuses of the break-up

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

. Read them carefully and weigh them. If necessary, consult a close

.

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

friend. After you become sure that you must break-up and that will

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

Companies that provide selfless information through particip

be in your interest and in the interest of your partner, go ahead.

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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