Just Answers - Computers and Technology

Have you ever stopped to consider what a seed is? A seed is nothing mor

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

e than a safety shell that contains the specific information inside to

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

Examples of combination products may in

grow into a certain type of plant. Let's call this an organic zip file?

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

The metaphor is a good one and although computers and plants are much d

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

ifferent when you think about it, really they are similar in this regar

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

Combination pro

.

Now lets take a USB Thumb drive which has a small program in it. Onc

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

e it is plugged into the computer it unzips and starts launching files.

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

So you see a seedling is similar to launching a program from a USB thum

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

b drive. Of course not wishing to take anything away from your belief i

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

a god the computer technology of a USB zip drive can go one-step furth

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

er.

You see, technology allows us to reverse evolution in computer pro

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

Following aspects would a

grams which is something we cannot do in nature. In other words a USB d

dd to the challenges in developing combination products:

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

ive can take a program away, erase its files and store it in the drive

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

for later. Seeds cannot do that. Once they are launched they either ful

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

ill their mission or they die. The tree which the seed has the informat

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

ion to create grows and produces more seeds.

We can do the same thing

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

Professional from academic institutions, pharmaceutical industries, health care indust

ith computer programs that grow and can be copied over and over again d

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

uplicating the original program. Although this is mostly philosophical

.

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

hought born of a Think Tank type mind, namely mine, I thought you might

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

Companies that provide selfless information through particip

enjoy this concept and comment. Let me know what you think of this one

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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