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Since birth we are being told that there is a supreme power called God who is the

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

creator of this universe. God acts like our parent. He rewards as well as punishes

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

Examples of combination products may in

us for our good or bad deeds.

According to one conception God lives in the sky o

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

in shrines like church, temple, mosque etc. and as far as second conception is co

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

ncerned it says that there are heaven and hell somewhere in or beyond the sky. Aft

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

Combination pro

er death our souls go back to God’s house where we are rewarded for our good deeds

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 earth and punished for bad deeds. We are sent to either heaven or hell - if rat

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

io of good deeds is high we are granted heaven and if ratio of bad deeds is found

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

to be high we are given hell. In heaven souls are pampered while in hell tortured.

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

In my opinion neither the first nor the second conception is right. God is the su

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

preme power and if he is supreme how it can be kept in particular thing or place?

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

Following aspects would a

Actually God is infinitive and shapeless. He is the base of this universe. He is e

dd to the challenges in developing combination products:

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

erywhere -in air, in water, in plants, in you, in me and so on.

Second conception

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

is absolutely wrong too. Heaven and hell are on earth not in the sky. God does pu

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

nish or reward us but not after the death. We have to be answerable to God in this

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

birth for our good or bad works. When we are found guilty of being unfair to other

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

Professional from academic institutions, pharmaceutical industries, health care indust

living beings we are punished by giving physical, emotional or economical loss an

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

d when we are thought to be kind we are showered with heath, wealth and happiness.

.

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

So it is in the interest of human being who has been searching God since his birt

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

Companies that provide selfless information through particip

h to understand what exactly God is, where he lives and how he reacts to our deeds

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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