Delicious - Travel and Leisure

To pursue my favorite hobby, I drive more than 15,000 miles a year, zigzagging across the United States on a giant scavenger hunt, collecting small sheets of paper with tin

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

y circles stamped on them.

I collect National Park cancellation stamps, which resemble the post office’s cancellation stamp you see on mail in your mailbox.

If you think

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

Examples of combination products may in

hat’s crazy, consider what I’m willing to endure to collect them: predawn rides on mail boats, border crossing guards searching my car, speeding tickets and even tornados.

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

So far, I’ve collected more than 300 of the 1,200 available stamps. Each stamp includes the name of the park, the location and the date visited.An estimated 125,000 to 25

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

,000 active collectors do what I do. A quick glance at my fellow “stampers,” as we queue up to get the stamp, tells me that we come in all sizes, shapes, ages and nationali

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

Combination pro

ties.

Some of us are hikers and marathon runners. Some of us have disabilities. We drive a wide range of vehicles--from motorcycles to RVs.

You can get in on the fun, too

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

by visiting the more than 460 national parks, seashores, lakeshores, recreation areas, historic sites, battlefields, memorials, monuments, trails, preserves, reserves, sce

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

ic rivers, parkways, and heritage areas across the United States.

Collecting these stamps relies upon attention to details, persistence and planning.

Sweat the Small S

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

uff

When I don’t pay attention to the details, I pay the price.

Once, while crossing the U.S.-Canadian border after collecting the Campobello International Park stamp

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

, I accidentally entered a secure customs zone, then took a picture of a lighthouse. Border guards caught me and made me stand against the wall of the customs guard house w

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

ile they searched my car.

While trying to collect the National Coal Heritage stamps in West Virginia, I received two speeding tickets. I guess I focused more on the stamps

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

Following aspects would a

and less on the speed limit.

Persistence Pays

It took a predawn mail boat ride to get the Acadia National Park Isle au Haut stamp. It was worth it because I got to

dd to the challenges in developing combination products:

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

see the sun rise over the bay. Lobster buoys, in every color imaginable, looked like confetti tossed across the water, bobbing and sparkling in the morning sun.

At Booker

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

T. Washington in Virginia, the ranger warned me about an approaching tornado. So I kept an eye on the violent sky as I pressed the stamper to the inkpad. In most parks, you

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

can apply the stamp yourself, usually in the ranger station. In some parks, the rangers apply the stamp for you.

Plot Your Course

At times, even the most extensive

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

planning can go haywire.On a hot and humid day, I headed out to find a stamp at the Fire Island National Seashore in New York. I chose the beach route, thinking it would

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

Professional from academic institutions, pharmaceutical industries, health care indust

e quicker. Soon people started pointing at me and waiving for my attention.

A few quick glances told the story. I was the only one wearing clothes on this nude beach. A la

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

rge sign posted by the walkway leading to the stamping station said it all: “Entering Clothed Area.” What a relief!

Reap the Rewards

These magical experiences will

.

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

last a lifetime. One of my favorites occurred on a low-flying puddle jumper from Key West to Dry Tortugas National Park in Florida. I looked down and saw turtles swimming i

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

Companies that provide selfless information through particip

the perfectly clear blue water. Incredible.

If you love scavenger hunts, learning about U.S. history and seeing amazing sights, experiences just like these await you, too

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.delicious.org.ua/article/334853/delicious-National-Park-Hobby--The-Scavenger-Hunt-of-a-Lifetime.html">National Park Hobby - The Scavenger Hunt of a Lifetime</a>

BB link (for phorums):
[url=http://www.delicious.org.ua/article/334853/delicious-National-Park-Hobby--The-Scavenger-Hunt-of-a-Lifetime.html]National Park Hobby - The Scavenger Hunt of a Lifetime[/url]

The traditional business plan is really only for one reason - to sell your business idea to investors. But, when the small, home-based business owner isn't looking for venture capital, this article presents a better business plan idea.

Along with various other natural remedies, DMAE supplements have been in use for several decades. The rise in popularity of these supplements raises the question of what exactly is their effect on the brain and are there any potential side effects.

Tags

Links

Delicious - National Park Hobby - The Scavenger Hunt of a Lifetime

Related Articles: