Summary - Relationships

If you have been married for any length of time, you understand that not everything always works out as smoothly as your undying love initially indicated.

T

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

here are often bumps in the road to marital bliss, even in the best relationships. This is a normal growth and learning process and if handled with love and

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

Examples of combination products may in

care actually further cements the marriage.

But what if you just can't take it anymore. It's over, you've had enough. Let me outta here. I was better off al

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

one.

Is your marriage really doomed?

You had better spend a little time evaluating the reality of your situation.

Often, if not nearly always, the whole p

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

oblem is one of miscommunication. I'm sure you've heard that before, however, I am talking about miscommunication with yourself.

What? Yes Yourself.

How h

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

Combination pro

ve you communicated the reality to yourself.

You see initially, you saw everything through rose colored spectacles. You fell in love, and that's why you got

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

married. Your partner could do nothing wrong everything was cute, precious, special, no matter how strange it might have seemed to other people.

Now, when

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

ome of your expectations aren't being met, theses same spectacles have turned a dark shade of black. Everything is stupid, uncaring, silly, negligent etc. th

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

same actions that were cute, are now stupid.

Again it is a matter of perception.

What makes the issue worse, is that the same thing has happened to your m

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

ate.

Where as before, all was rose colored from both sides, a condition which reinforced itself by the mutual agreement, this has now worked exactly the sam

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

way in the opposite direction, pushing you further apart.

Both are looking for the negatives in each other, both will find them. The positives have been di

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

Following aspects would a

carded as average, the negatives raised to a higher, more important level.

This can only lead to a break to stop the feelings of disappointment.

If this is

dd to the challenges in developing combination products:

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

the case, so be it, but......and this is a huge but, what if your perception was not quite as accurate as you thought.

What, heaven forbid, you might actua

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

ly be mistaken. I know this is an absurd notion to consider at this point, but just for the sake of argument, what if you just worked with that new perceptio

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

for a while. Could, would this make a difference? I daresay yes.

This is where counseling comes in. A skilled counselor, will try to establish a sense of

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

reality back into the relationship and level the playing field.

Only when you can both see clearly again, should a decision for the future be made.

If at a

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

Professional from academic institutions, pharmaceutical industries, health care indust

l possible, a separation should be avoided. Here's why.

The costs of a divorce are huge. I am not merely talking monetary terms here either. The actual rami

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

ications of divorce are a topic for another time though.

For now, to be fair to everyone, especially yourself, you owe it to the relationship to get into 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

clear thinking state of mind, before making any potentially life altering decisions.

Remember, there was a reason you got together. Can this be resurrected,

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

Companies that provide selfless information through particip

modified to adapt to changing conditions? Could the love be rekindled?

Can the Marriage be saved.

Try whatever you are able to not become another statistic

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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Summary - Can Or Should Your Marriage Be Saved?

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