Advice Pool - Relationships

I was married for almost 30 years and, to everyone who knew us, it appeared we had found each other’s ‘soul mate.’ I never disagreed with these well-wishers, b

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

ut often wondered what that really meant. If they were describing ‘compatible,’ ‘harmonious.’ ‘like-minded,’or ‘in-tune,’ I would concur. The next most over-us

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

Examples of combination products may in

ed term is ‘having chemistry.’ If they mean that we were both carbon-based life forms, again, a big, affirmative. But when we go down the ‘soul mate’ lane, we’

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

re treading on a spiritual path that has many other implications. We would have to explore the very depths of what composed the human soul and how it would eve

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

n be possible that somewhere in the vast cosmos there is a destiny that dictates a potential perfect ‘soul-match.’

The Webster’s definition of ‘soul’ is: “the

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

Combination pro

complex of human attributes that manifests as consciousness, thought, feeling and will, regarded as distinct from the physical body.”

So we are entering the

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

realm of the intellectual and philosophical study related to the human mind and inner being. This concept has been the fodder for religious arguments since bef

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

ore biblical times. When does the soul enter the body near conception and where does it go after death? Answer that question and you can write your own article

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

.

Suffice it to say, we don’t know much about the subject of what constitutes a person’s psyche and inner spirit. Whether that ethereal element has the abilit

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

y to seek out a suitable companion is suspect, at best. I would put my faith in my own capability of recognizing someone with similar values and interests by e

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

mploying the simple act of conversation. This would require several interactions via e-mail, mail, phone calls, or in person to accomplish the task. It sure ta

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

Following aspects would a

kes the pressure off of finding that ‘soul mate.’

Which brings up a finally problem. If we do have a ‘soul mate’ that has been molded by the creator, is it a

dd to the challenges in developing combination products:

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

single entity? It would be logical to assume that we don’t have multiple ‘soul mates.’ If that were the case, it’s a darn big world out there. Who is to say th

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

ey are of the same ethnic, religious, or national background. Might mine be somewhere in France, Japan or Kenya? How would one go about finding that elusive sp

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

irit? Place an ad on the web? I’m not being sarcastic at all. If it’s an inner-being type quality, how can you possibly search for a person that could literall

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

y be anywhere? And, if they could be located, would they immediately recognize you as their perfect match? What if they were Israeli, but you were Iraqi, how w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould that work out?

I didn’t intend to dash any hopes and dreams, but rather to be realistic. I have found a wonderful second wife that meshes well with my va

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

lues and interests. And that’s about the most I could hope for. She doesn’t actually consider me her ‘soul mate’ and that’s okay with me. We get a long quite w

.

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

ell, regardless of what we call our relationship. I suggest that those of you who are on a quest for the perfect match settle for a reasonable expectation befo

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

Companies that provide selfless information through particip

re life passes you by. There are probably many people out there you can be happy with, and not just a special predestined, one. But a ‘soul mate?’ Myth busted!

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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Advice Pool - Mythbusters: There's a Soul Mate for Everyone

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