Summary - Relationships

How many times this week only, you had an encounter with someone who either pushed your buttons or you simply didn

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

’t like, meaning, the chemistry wasn’t there?

It happens often. We hate the guts of this or that person, or we th

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

Examples of combination products may in

nk that there is something wrong with them. Somehow we become absolutely critical and thus create an inaccurate an

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

biased image of someone and nothing that person does is quite all right.

Of my many cases, there is one that I l

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

ike to talk about. I was taking a course and we met 3 times a year for 5 years. Now, that is time enough to get kn

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

Combination pro

w people. So, there was this woman, who was pleasant enough and very friendly and smiley, but as soon as she opene

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

her mouth, I would roll my eyes and think: oh, boy, here she comes. Can’t she just shut up? For 4 years I did tha

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

t, until I realized something.

This thing is: “we cannot find in others what we ourselves do not possess.” In oth

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

r words: everything that we claim to find in people is something that we also have, or we wouldn’t be able to reco

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

nize it, be it positive or negative.

So, do you find a person friendly? So are you. Do you find a person arrogant

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

So are you. Is this person competent? Funny? Giving? So are you. Is this person authoritarian, stubborn, prejudic

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

Following aspects would a

ial? So are you.

I know that you might be snapping at me at this point, but trust me; this is absolutely true. Wh

dd to the challenges in developing combination products:

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

t we don’t like in others in usually a reflection of our own qualities. Based on this, it is imperative that you t

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

ke action when you meet someone who, one way or another pushes your buttons. Then you ask yourself one or more of

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

the following questions:

1. What does this person have that I, too, have, but somehow I am denying it in myself?

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

2. What does this person have that I never knew I had it as well until now and I now that I know, I don’t like it?

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

Professional from academic institutions, pharmaceutical industries, health care indust

3. In what sense is this person just like me?

4. What characteristics do I have that I don’t like and that I see

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

reflected in this person?

5. What am I reflecting or projecting?

Try to find what bothers you and seek in yours

.

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

lf where the same quality is. It will help you tremendously. Coming back to my story; that woman in my course was

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

Companies that provide selfless information through particip

rench-Canadian. She spoke English with an accent, as she is foreigner. So do I. We then became the best of friends

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 - Who is Pushing your Buttons?

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