Advice Pool - Relationships

Everyone knows the Golden Rule, “Do unto others as you would have them do unto you.” Pretty simple, and pretty good.

And I’d like

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

to humbly submit the upgrade, the Platinum Rule, “Do unto others as they would have you do unto them.”

What do I mean?

We all k

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

Examples of combination products may in

ow that everyone’s different — one man’s trash is another man’s treasure, to quote another folk staple. So why do we assume that s

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

meone else would want to be treated the way we wish to be treated? Yes, everyone wants courtesy, respect, love, support and all th

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

se other wonderful, non-specific words (nominalizations, for you NLPers). But one person may equate support to being left alone in

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

Combination pro

her grief, while another may equate it with constant companionship.

The Golden Rule can even create problems. Here’s one example:

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

my first husband liked to get his information auditorily, because had a phenomenal auditory memory; he couldn’t see very well, tho

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

ugh, and had a lousy visual memory. I, on the other hand, with a great visual memory and a terrible auditory one, wanted to see my

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

information. But of course, we didn’t understand this, and assumed each other’s memory was just like the ours.

So, using the Gold

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

n Rule, if I needed to remind him of something, like what to get at the grocery store, I’d leave a note on the back of the front d

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

or, where he’d be sure to see it on the way out in the morning, and could take it with him to use at the store in the evening. Of

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

Following aspects would a

ourse, half the time, he never saw the note! If he needed me to call someone to renew the auto insurance, he’d tell me before he l

dd to the challenges in developing combination products:

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

ft for work — and it would slip my mind.

And in the evening, he wouldn’t have gotten what we needed at the grocery, and I wouldn’

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

have called the insurance agent! Multiply this by a hundred times, and you get the picture. I felt ignored, and he felt like he w

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

asn’t being heard. It was a constant source of friction in our marriage.

Then I learned about representational systems, which are

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

all about how you take in and store information. Some people, like me, are very visual, others primarily auditory, and still other

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

Professional from academic institutions, pharmaceutical industries, health care indust

primarily kinesthetic, so they learn by doing. I explained this to my husband, and we began to live by the Platinum Rule — I’d te

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

l him what I needed, and he’d leave me notes. Much better, even though it felt a little weird to both of us!

So, how do you put t

.

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

e Platinum Rule into action? Any time something isn’t going well in a relationship, ask yourself, do I know what the other p

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

Companies that provide selfless information through particip

rson wants, and how they want it? If the answer is ‘no’, or even ‘maybe’, ask the other person! You’ll be glad you did

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 - The Platinum Rule

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