Summary - Relationships

I did everything possible to save our relationship. I gave in a lot, but I could

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 save. We will be breaking-up soon. That has already broken my heart. This r

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

Examples of combination products may in

lationship was made brick by brick over so many years. What all we did not do to

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

make it last? But alas, we are breaking -up. This is a typical statement from a

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

person facing break-up. How to survive after a break-up? Will you survive a brea

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

Combination pro

k-up? Why not quiz yourself about it?

The immediate effect of the break-up woul

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

be pain. Will you be able to take the pain? The pain would go away slowly over

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

a number of years, but the initial impact will be high. You will have to gather

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

ll your energy and tolerate the pain.

The second effect would be bitterness and

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

blame. You will keep thinking about the behavior of your ex partner and fix bla

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

e everywhere. You will recap all the arguments and fights and there will be a la

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

Following aspects would a

ge amount of self-talk about how you were ditched. That will not be a pleasant e

dd to the challenges in developing combination products:

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

xperience. You will have to find way out of all this by spending quality time wi

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

h friends, involving you in new activities, and keep yourself busy. Are you read

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

y for that?

The major effect would be the temptation to join immediately with a

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

ew partner. This can work both the ways. Some people never wish to form a relati

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

Professional from academic institutions, pharmaceutical industries, health care indust

onship again after undergoing the trauma, while some want to form a relationship

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

as soon as possible to forget the earlier one. Both of theses choices carry dang

.

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

er. The best alternative is to wait for sometime and when you find your stabilit

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

Companies that provide selfless information through particip

and self esteem back, try and form another relationship. Are you ready for this

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 - Quiz Yourself - Will You Survive Break-Up?

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