Advice Pool - Relationships

In the early days of love it all seems so bliss filled and romantic -- and it feels like it will last forever.

Then you settle down, get marri

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

ed, create a home, have kids and......where did the magic go!? There's so much to do, the errands never end, the house always needs work, t

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

Examples of combination products may in

e kids are demanding, and your love seems to have slipped away. Or has it?

You wish you felt more connected. You wish it was more like it wa

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

in the beginning when you couldn't get enough of being together. And perhaps you feel overburdened and lonely doing the chores and making

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

living and taking care of the kids and . . .

Well, please be kind to yourself, your partner, and your relationship and check to see if yo

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

Combination pro

both feel the same way. Chances are you do. And chances are really good that because you've cared enough to ask, this kindness will open new

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

possilbities for deciding to do more of the daily family maintenance and caretaking--together!

Sure you may have different schedules. But

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

surely you can find some time when you BOTH fold the laundry (while watching TV, perhaps!), pick out a new paint color for the bathroom (ev

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

n if one of you has to bring home a bunch of swatches from the home deco store and look them over late at night) or take the kids to the birt

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

day party together (even if you have to forego a golf game or shopping trip just this once).

You may be thinking, big deal, it's still a cho

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

e to do that stuff. Yes, that's true is you only hold on to a worker-bee attitude. But if you approach these tasks as ways to be kind and m

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

Following aspects would a

ake life more enjoyable, then you will be well on your way to finding the daily romance in workin' it out together.

Judith: Even if we seldo

dd to the challenges in developing combination products:

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

have company that will be shown around our house (meaning they get to see our bedroom on the second floor), we both make the bed together

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

early every morning. We've remarked on how much this mundane kindness reminds us of our care for each other and for our home.

Jim: Frequentl

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

one of us washes the dishes after dinner and the other dries. The tasks may be menial but the bondedness of consciously doing them together

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

s revitalizing and endearing -- while making the work more fun!

Find just one thing you typically do alone and figure out how to make it a f

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

Professional from academic institutions, pharmaceutical industries, health care indust

orm of daily kindness to yourselves and to your relationship. The practice of teamwork, a joint contribution to being together, will allow yo

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

to trust one another more and create new avenues of shared experience and discussion.

And be as kind to yourselves as you might be to outsi

.

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 help.For example, include your favorite snacks and good music if you're doing something like building a new fence, re-doing your flower b

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

Companies that provide selfless information through particip

ds, painting the house or cleaning out the garage.

Be kind to one another and make it as fun as possible to to get the work done--together

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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