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"Everyone says that my way of life is the way of a simpleton. Being largely the way of

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

a simpleton is what makes it worth while.

If it were not the way of a simpleton, it wo

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

Examples of combination products may in

uld long ago have been worthless. These possessions of a simpleton being the three I ch

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

oose and cherish:

To care,

To be fair,

To be humble,

When a man cares he is unafrai

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

d, When he is fair he leaves enough for others, When he is humble he can grow;

Whereas

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

Combination pro

if, like men of today, he is bold without caring, Self-indulgent without sharing, Self

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

-important without shame, he is dead.

The invincible shield of caring is a weapon from

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

the sky against being dead."

These words were written over 2500 years ago in China. L

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

ao-tzu the hermit and social outcast wrote a small book called the Tao Te Ching, that c

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

ontains 81 thoughts. It's written so we can look at and understand physical life in ver

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

simple terms.

I have been known as a simpleton on many occasions and it's definition

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

Following aspects would a

is not the same as the simpleton that Lao-tzu describes. It is someone who is fooled or

dd to the challenges in developing combination products:

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

easily deceived by something or someone. Someone who does not conform to truths of the

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

day, and lives a life that is unique by thinking in a different way, but as my friend

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

Lao-tzu explains, a simpleton can be someone who I want to become, by knowing 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

The three possessions; to care, to be fair, and to be humble are valuable things to hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e. With those jewels, I can experience my truth. I can express myself in simple terms.

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

I can become the change that I seek. I need nothing other than those 3 attributes to li

.

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

ve a joyous physical life.

Being a simpleton is a word filled with honor. It is a syno

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

Companies that provide selfless information through particip

nym for abundance. It is the formula for peace within me.

Simple is, as simpleton does

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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