Advice Pool - Reference and Education

There is a popular assumption that if you move to higher latitudes (toward the poles) you can escape the heat, and that by moving to lower latitudes (tow

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

ard the equator) you can escape the cold.

The equation is simple. But is it real? If it was, then the most northerly capital, Reykjav?k, would also be

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

Examples of combination products may in

the coldest...at least until they establish a country on Antarctica. Yes, it appears that latitude is slacking off and failing to keep temperatures in l

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

ne.

This was brought home to me when preparing for a radio interview in Dublin, Ireland. February had just roiled in and I was sitting back comfortably

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

in my good old glacial Ottawa, Canada, weather, scraping icicles off my toes. I was giddy with excitement over our warm spell, which it was reaching a

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

Combination pro

igh of minus-5 (that's about 20-degrees American). I always ask questions the day before an interview, to learn a bit about my audience, so I asked the

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

roducer, "So what's the weather forecast for Dublin, Ireland?" asked.

"Oh it's horrible," she told me. "People are bracing for a deep winter freeze tha

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

t's supposed to hit tonight. It might even get as cold as minus-5!"

This blew me away, that the folks in Dublin would be worried about the thermometer

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

ips as low as ours spikes high. After all, isn't Dublin about the same latitude as Ottawa?

Weather forecast from an atlas

I whipped out my trus

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

y atlas. We live almost exactly on the 45th parallel. If we lived exactly on it, we would have to share our bed with a cow and a dozen chickens across

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

he road – that's how close we are.

I turned the pages to find Ireland. Could I have been mistaken? Is Dublin really quite south of us? No, it turns o

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

Following aspects would a

ut that Dublin lies at the 53rd parallel. Hey! They should be getting colder weather than us. That's not fair.

The weather is not fair. Dublin is way

dd to the challenges in developing combination products:

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

o the North of us, so why do we get all the cold?

I decided to take a peak at a few other pages of my atlas. Lo and behold, Venice is also on the 45th

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

arallel. Let me tell you that the weather forecast for Venice, Italy never calls for getting buried in snow for three or four months of the year...unles

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

s you happen to be viewing "The Day After Tomorrow". In fact, the average temperature in Venice in January is +1 (that's about 34-degrees American).

Hm

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

. I wondered what else lay along the 45th parallel. The French Riviera. Not too much ice going on there. Portland, Oregon. I checked the Portland, US

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

Professional from academic institutions, pharmaceutical industries, health care indust

, weather forecast. Yup, same as Venice in January. And Sevastapol, Urkaine, also with January temperatures near Venice.

In fact, no other well-popula

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

ted area of the world endures so much cold (except parts of Russia, but many of those people can't afford the taxi fare to go somewhere else).

So why do

.

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

so many people with so much wealth live in such an inhospitable climate? I don't know. Maybe we are waiting for latitude to correct this little anomaly

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

Companies that provide selfless information through particip

Or maybe our brains are simply frozen. Or maybe that's why so many people around here head south to enjoy that warm Orlando, Florida, weather forecast

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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