Summary - Relationships

Relationships with good friends are always wonderful. Is that true? Have you ever had th

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

e experience with someone you dearly like as a friend that it just feels exhausting to b

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

Examples of combination products may in

with them sometimes? One reason might be the ‘cardboard image’ effect.

When you first

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

meet another person you create a file in your head with the information you gather. Ever

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

time you meet, new information is added to the file. After a while you believe you know

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

Combination pro

this person and you have some expectations on how they should behave. When the other per

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

on does not act based on the information on your file (your expectations) one reaction m

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

ght be: ‘But hey, on my file it says “always happy”, so why are you so annoyed?’ Another

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

reaction might be: ‘No, this is not the way I know you; you’re supposed to behave like t

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

is….’ These reactions are directed at the ‘card board image’ you have of someone else, t

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

eir stored data on your file.

And what does it look like from the other side? You might

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

Following aspects would a

have a conversation where your friend is talking to your ‘card board image’ instead of t

dd to the challenges in developing combination products:

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

e ‘ever changing you’. They are referring to the you that they knew when you where in Un

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

versity together. This can be stressful, especially if there is a strong desire in your

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

riend for you to BE the old self they are used to, your ‘card board image’, or a disappo

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

ntment over the fact that you are not. You feel as if your friend is not really talking

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

Professional from academic institutions, pharmaceutical industries, health care indust

o you but a former variation of yourself. There is a sense of not being acknowledged for

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

being yourself and you might want to say: ‘Hello, I’m no longer that person in Universit

.

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

; I have developed since then…’

So next time you meet up with a friend leave some space

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

Companies that provide selfless information through particip

in your file to add more information on however that person presents in that moment anew

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 - Stressful Relationships: The 'Cardboard Image' Effect

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