References - Recreation and Sports

Have you ever watched one of those televised shows that show the fabulous fishing available in Canada, (or also known as the "Great White North) & wo

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

ndered, can that really be true? Can the fish actually be so huge? Can the scenery be so spectacular?

It IS true!

From the eastern shores of the Ma

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

Examples of combination products may in

itime Provinces to the vast wooded tract of coastline on the west shores of British Columbia, Canada offers fishing that is so abundant & unspoiled,

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

hat anglers from around the globe visit each year, then subsequently return year after year.

All Provinces offer fishing that is unique to them, ye

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

all are connected by a common theme, & that's the huge expanses of almost undiscovered lakes & rivers in the northern regions.

Look at the Province

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

Combination pro

of Ontario, 95% of its population reside in the lower regions that account for maybe 10% of its land mass. What's in the other 90%?

Huge, crystal cl

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

ar, lakes & rivers. Thousands of them! And all full of fish.

Whether one is looking for a weekend retreat that's accessible with your family car, or

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

the "trip of a lifetime", a visit to a remote northern lake accessible only by float plane, this province offers it all.

Compare that to the even la

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

ger expanse of the Nunavut. Here's a Territory that sits almost entirely north of the 60th parallel, & has almost all it's regions inaccessible by ro

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

ds. There simply are none!

But the fishing! Home to more I.G.F.A records than any other fresh water region in the WORLD!

Did you know the N.W.T is

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

ome to the 5th largest body of fresh water on the globe?

Great Bear Lake is 500 miles north of Yellowknife & the closest permanent road is some 300

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

Following aspects would a

miles away? Almost 12,500 square miles of crystal clear water, that's under ice for all but, maybe 100 days a year. Water so cold, that fish grow so

dd to the challenges in developing combination products:

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

lowly they can be 60-80 years old.

Then consider this.

There is only one community on this lake. Maybe 500 people, tops! Four Fishing Lodges, over

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

80 miles of lake between one & the next closest! Ice free for just a couple of months, these fishing lodges can operate only 2 short months a year. T

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

tal capacity between them all is maybe 160 fishermen at a time, scattered over 12,500 square miles!

Also, consider Great Slave Lake. Situated some 3

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

0 miles south of Great Bear Lake, Great Slave Lake is almost as large an expanse of water, almost as isolated, but has the convenience of a bustling

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

Professional from academic institutions, pharmaceutical industries, health care indust

rontier type city, situated right on its shores. Yellowknife, the territory capital is also the "hub" for many of the remote northern lakes & fish

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

ng lodges, as it's serviced by a modern airport, with frequent & daily scheduled flights connecting it with more southern cities, or as the northerne

.

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

s call it, "the outside"

With stats like these, do you think these fishing lodges can offer a unique fishing experience?

You bet, there is no other

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

Companies that provide selfless information through particip

place quite like it.

Why not treat yourself, & plan on a wonderful "trip of a lifetime".

Check out what Canada has to offer at Canada Fishing Lodge

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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