I Suggest - Home and Family

Once upon a time there were three little pigs. They all once had families, but unfortunately, they were all now divorced. So they decided to re-marry and build brand new

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

homes with their new families.

The first little steppig (as they were now known) was in a great hurry to start a new family. So she didn't even think about foundatio

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

Examples of combination products may in

ns, or rules, or how they would build their home, she just went straight to work, using whatever was quickest as material, which was straw. Too bad! The first storm th

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

at came along blew their straw house away. They gave up and got another divorce. And everyone was miserable.

The second little steppig was also in a hurry, but she had

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

watched her friend and learned a lesson - sort of. She laid down the rules for her new steppiglets. They decided together to use good strong sticks for their new home.

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

Combination pro

Huh-oh! A few storms later and their commitments and rules fell apart, just like their stick house. Another miserable divorce!

Now the third little steppig had been

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

paying close attention, so, before they even married, she and her new mate sat down with a good friend they trusted and talked - a lot! Together they decided about the

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

ir family rules, but they also agreed on how they wanted their new home to look and about any new additions they might need to build on. They discussed their fears, as

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

well as their dreams, and what kind of parents they wanted to be to their piglets. Finally, they chose their building material - solid stones with sturdy mortar betwe

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

en them.

Storms came (they always do!) and beat on the little steppigs' home, but they were able to batten down the hatches and ride them out - together. The piglets gr

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

w up and left home to form healthy piggy families of their own, always remembering how their parents had worked together as a team. And the piggy couple lived happily

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

Following aspects would a

ever after.

The Moral of The Story:

Second and third marriages experience 65 percent and 85 percent divorce rates. Most stepparenting couples had no - or very slim -

dd to the challenges in developing combination products:

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

guidelines drawn up for their family before they married. They just bumped into each other, got their licenses, and hit the road ... to divorce court!

On the other han

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

d, couples who have strong homes tell me they laid out very specific plans together. They are just looking for some guidance and encouragement through the storms (whic

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

h always come).

If you're a single parent, divorced, or engaged to a single parent, NOW is the time to get help planning how to build a successful stepfamily. If you're

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

already in a stepfamily, NOW is the time to get help in developing your short, mid-, and long range plan to stay together and raise healthy kids together.

The only w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ay to build your new home together so it will withstand the storms (that always come) is to build on a Solid Foundation (I'm talking Jesus here) and to draw up good, d

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

etailed plans. You need to develop household Rules, exceptions, and discipline, and lifelong plans, such as your Couples' Mission Statement and your personal goals for

.

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

every step of your family's change and growth. You've got to be prepared for and expecting the storms and have definite procedures you'll follow to survive.

It ain't b

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

Companies that provide selfless information through particip

rain surgery, kids! But then, maybe it is a little like making alterations to your way of thinking. Don't try to build without your Plans, and if you need us, we'll help

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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I Suggest - Three Little STEPpigs

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