E-Articles - Health and Fitness

For many years I labored under the delusion that when doing my normal outdoor activities such as fishing, hiking, mountain bi

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

king, and skiing polarized glasses were neat and everything, but not worth the price that some people pay for them. So I did

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

Examples of combination products may in

what a lot of people do. I feel into the routine of buying inexpensive, or should I say cheap, polarized glasses. I mean,

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

I simply wasn't going to spend like $100 on a pair of sun glasses, and that was that.

So I did what I normally did, and boug

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

ht a new pair of polarized glasses every year, and never spending more than $20 for them. And why did I buy a new pair every

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

Combination pro

year? Because they never seemed to work right, and they would invariably end up scratched, and/or I would simply lose them.

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

This cycle went on for quite a few years, until one day when I was looking for a new pair of polarized glasses, a friend of

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

mine told me to use his for a couple of days instead. I took him up on the offer and had an epiphany of sorts.

I used thes

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

e borrowed glasses for a week or so in which time I went both mountain bilking and fishing. I was totally amazed at these bo

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

rrowed polarized glasses. The clarity and comfort they provided was almost unbelievable. I truly couldn't believe it. When

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

I returned the glasses, I asked him how much they cost him? He said it was a couple of years ago, but something like $150.

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

Following aspects would a

I almost had a heart attack! But he said, "Dude, you get what you pay for". I went on my way to buy yet another $20 pair o

dd to the challenges in developing combination products:

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

f polarized sun glasses, but just couldn't bring myself to do it. I was so impressed with my friend's glasses that I did it.

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

I bit my tongue and spent $150 on a pair just like he had. That was 7 years ago! I still have the same polarized glasses!

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

I found out that if I spent that much money on them, I took great care of them, who would have thought? I was think

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

ing about it the other day and realized something. If I amortize the cost of my glasses, they only cost me about $22 a year.

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

Professional from academic institutions, pharmaceutical industries, health care indust

That's less than I used to pay for the cheap ones! I was amazed by this. I guess sometimes just because the cost seems st

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

eep upfront, in the long run, it's actually a better deal.

In the case of polarized glasses, not only do the quality ones en

.

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

d up being a better deal, the functionality is so much better, it really can't be explained in words. Until I got my quality

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

Companies that provide selfless information through particip

polarized glasses, I really didn't have a clue what polarized glasses were actually like and how much better they really are

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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