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Business relationships are typically reserved and careful. This makes conn

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

ecting to people difficult at best. The Six Universal Principles offer alt

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

Examples of combination products may in

rnatives to this professional distance, alternatives with which people can

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

maintain professional standards and yet, still allow people to personally

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

onnect. Know these six principles derive from Emergence Personality Theory

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

Combination pro

[1] Arriving "The meeting begins only when everyone "arrives."

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

i>(Connecting not only leads to wealth, it is wealth.)

[2] Only Ex

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

erience Teaches "The order people usually teach in is: facts, princip

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

es, experience. The only true order for teaching is: experience, princip

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

es, facts." (Connecting begins only when you experience the picture to

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

ether.)

[3] Augment Don't Compete "Add to the good which is a

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

Following aspects would a

lready there, rather than finding fault." ("Ands" connect; "Buts" butt

dd to the challenges in developing combination products:

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

heads.)

[4] Too Much Information "There will always be "too m

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

ch information." (If you bury someone in good information, you have st

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

ll buried them, and no one can connect to a person who is buried in

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

ata.)

[5] Containers "Always know the size of you and your client

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

Professional from academic institutions, pharmaceutical industries, health care indust

s containers." (Always know the limits of what you and they can experi

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

nce.)

[6] Make Universal Investments "Universal Investments a

.

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

ways satisfy both bosses." (Honor both the "head" and the "heart."
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
This connection is the Universal connection which leads to arriving....

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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