Just Answers - Computers and Technology

A mother of three wanting to surf the net, I would sit down at my

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

computer to find that my mouse was moving and opening up window bo

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

Examples of combination products may in

es and then closing them. My dos opened a few times and then some

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

typing was going on, but it was really fast and as soon as I would

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

move the mouse around myself- all my opened windows would begin to

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

Combination pro

close. It really scared me, until I realized that it was no ghost

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

I was even more freaked out to learn it was some jerk that hacke

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

d into my computer over and over again for months!!!! I changed my

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

windows password several times, and I put up messages on forum sit

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

es hoping to find the problem, but it did not stop him/them. I wa

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

so scared that this guy woudl steel all of my information on the

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

Following aspects would a

omputer.

I finally one day opened up a word doc and said "LEAVE M

dd to the challenges in developing combination products:

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

E ALONE" it slowed things down a little, but especially at night i

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

when the activity would start up again. Then it hit me, I felt l

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

ike an idiot! I found out that they were getting through with my

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

NC for the last 5 months.. VNC is a program that lets others cont

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

Professional from academic institutions, pharmaceutical industries, health care indust

rol your computer from far away. My brother had installed it on my

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

computer a few months back, and it had no password protecting it.

.

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

I guess I had it open to the whole world that whole time. So if y

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

Companies that provide selfless information through particip

u have this program and you are not using it- get rid of it. Anna:

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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Many people’s immediate reaction to the suggestion of giving a presentation is to try and get out of it! There are all sorts of reasons for this reaction and this article looks at the most common barriers.

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There is nothing quite as difficult for a home seller than to see their home sitting on the market getting no offers or interest from buyers. It is even worse if they have reduced the price a few times to no avail.

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