Useful Articles - Relationships

The desire to touch and be touched is classified as a sweet addiction.

It is inherent in

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

human nature to be nurtured by the sense of touch. We, as human beings, have varying degr

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

Examples of combination products may in

es of “need to be touched”, which can change over the course of our lives. At some period

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

s, we need to be touched, held, and embraced closely and often. At other times, we feel a

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

need to maintain our own personal “space”, and don’t want or need as much closeness.

I wo

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

Combination pro

ld submit to you that the barometer of the desire to be touched is not based on one’s leve

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

l of insecurity, but actually quite the opposite. I would submit that an individual who i

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

willing to open themselves up to the vulnerability of relationships with others is indeed

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

much more secure about themselves, who they are, and what they are seeking in life. They

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

are more willing to take the risk of developing friendships and love.

Most of those willi

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

g to take the risk are not rookies, or new to the experience. Many have taken the risk be

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

Following aspects would a

fore and have failed. But they are willing to try again. The reality, here, is that true

dd to the challenges in developing combination products:

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

friendship and love really are worth the risk, over and over and over again.

The sweetnes

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

s of the success of a good friendship and a true love far outweighs the trials and errors

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

hat may precede them. To find that soul mate friend, to discover the depth of eternal lov

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

, is worth the risk.

Someone once said, “It is better to have loved and lost than to neve

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

Professional from academic institutions, pharmaceutical industries, health care indust

r have loved at all”. And it is true. True love, true friendship can not be bought or so

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

d. Yet, the commitment we surrender to the effort amounts to a level of sacrifice and joy

.

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

that can not be calculated in human terms. It is the price of the heart. It is the gift

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

Companies that provide selfless information through particip

of the mind. It is the joy of the soul. It is the ultimate discovery of consummate peace

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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Useful Articles - Risk and Vulnerability

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