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Many things in life are aggravating. In fact, one could argue that life itse

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

lf is aggravating. However, for the purposes of this discussion, let's deal

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

Examples of combination products may in

ith aggravation as a cost of doing something. We'll measure it via AI = Aggr

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

vation Index:

VL = VERY LOW
L = LOW
M = MEDIUM

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

li>H = HIGH

VH = VERY HIGH

Here's an example: you find a We

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

Combination pro

b site with thousands of free eBooks, titles only. Aggravation Index - VH. Y

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

u'll have to download and parse each one to find out its value. Despite 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

act they're free, many may be worse than useless - they'll be wrong, outdate

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

or simply waste your time. My time is very valuable - how about yours? Lear

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 to value your time very highly and you'll reduce your stress immensely.

H

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

re's another: you grow tomatoes in your garden, with all the work involved t

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

Following aspects would a

make them excellent. AI = VL. You find the physical work relaxing, the chor

dd to the challenges in developing combination products:

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

s are a time to reflect and enjoy being outdoors, the bugs and weeds are par

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

t of the process, and the result is delicious. Even if you never sell one fo

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

profit, you still get the full enjoyment of them for yourself and those who

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

receive them. Sometimes, giving away your best is enjoyable.

The next time

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou think you've found a bargain, examine it for AI. You might find you've sa

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

ved yourself some time, effort and, yes aggravation. Also, feel free to shar

.

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

your AI knowledge with others. I've actually rated myself as AI = M. I feel

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

Companies that provide selfless information through particip

I have a Constitutionally protected right to annoy others, but not to excess

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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