Summary - Self Improvement

What If?
What if I can't?
What If I can?

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

What I should be thinking
Is it in God’s plan?

What

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

Examples of combination products may in

if I couldn't?
What if I could?
Then I start

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

to wonder
If I really should?

What if I wouldn't?

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

What if I would?
What would I do,
If ot

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

Combination pro

ers really understood?

What if, I am beautiful,
Ju

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

st as I am.
That a scale means nothing,
When

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

alking to a human.

What if, I am worthy of love,
J

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

ust by being alive
What if,
I don’t have to pr

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

ve myself
Or feel ashamed to cry?

What if,
B

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

y some chance,
All my negative thoughts were wrong.

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

Following aspects would a

That I am free to sing and dance,
That I am no

dd to the challenges in developing combination products:

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

weak or strong.

What if, I did not make excuses,
I

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

simply threw them out the door.
What if, I started

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

etting honest,
and I started at my core.

What If…

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

When I am living in the present,
there is no reason

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

Professional from academic institutions, pharmaceutical industries, health care indust

for me to fear,
the what if's that surround me

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

and the negativity that is near.

When I am in the here

.

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

and now
and take some time to breathe,
I real

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

Companies that provide selfless information through particip

ize that anything is possible,
as long as I believe

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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