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Okay, you could come up with some twist or some edge that would really set you apart. N

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

ow, writing an e-book. Have you written a book before?

Writing an e-book can be as sim

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

Examples of combination products may in

le as writing out this list of ten things and then having ten things that belong in ther

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

e, writing one article about each one of these 100 things, okay? The first set of ten t

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

ings under fitness would be your chapters. Now remember, this can be 15 or 20. We're u

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

Combination pro

ing ten to make it nice and easy. You have your ten chapters. So...give me three things

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

you know about fitness. I want to make this real and tangible here. What are the firs

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

three areas of fitness that you know something about?

That's fine for this. We're jus

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

t brainstorming. How about exercises, certain exercises? Now we've got equipment. So

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

your first chapter... I don't even want to say first chapter, but one of your chapters

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

ould be on equipment... one of your chapters would be on weight loss, one of them would

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

Following aspects would a

be on exercises. Then you'd go through it and you'd have these ten other ideas, so you'

dd to the challenges in developing combination products:

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

have your ten chapters.

Probably come up with 12 or 15. Then what you'd do is you'd h

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

ave ten topics underneath this equipment. You'd have 10 topics underneath weight loss an

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

you'd have 10 topics underneath exercises. You know, you may have more than that. Und

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

rneath exercises, you might write one article about each exercise. You might have 25 art

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

Professional from academic institutions, pharmaceutical industries, health care indust

icles there.25 different exercises. When you write this collection of articles, three or

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

four hundred words apiece about each one of these little topics that you know, if you or

.

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

ganize them in the same way that we're talking about right here, you're going to end up

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

Companies that provide selfless information through particip

ith a 150 to 200 page book. If you don't really just try to hold yourself to ten and ten

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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