Social Space - Travel and Leisure

In my family, we have camping lovers and camping haters. My husband, kids, and I love to go camping. My mother just stares at me every time I talk about an upcoming

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

camping trip and asks why I want to leave my brand new home that has a brand new bed with a brand new mattress so that I can go sleep in the woods on a mattress I fi

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

Examples of combination products may in

ll with air. Being the articulate person I am I say, “Because it’s fun.”

It’s hard to explain to a non camper how relaxing it is to be out in the open air all day a

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

t a campground with miles of trails to hike and bike; or by a lake to go swimming, boating, or fishing in.

I tell my Mom how it’s fun to explore the area trails; loo

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

king at the views, the vegetation, and the wildlife. For example, during a recent camping trip an evening bike ride brought me within 10 feet of a baby deer out with

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

Combination pro

its mother. It’s hard to explain how fun it is to be able to see something like that. But instead my Mom asked me how bad the bugs bit and if I got sunburned du

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

ring that day’s hike.

Then I try to explain to her about how much fun it is to sit around the campfire at night. It’s a great time for casual conversation and to ha

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

ve a beverage and maybe a few toasted marshmallows or S’mores. I love watching the flames and listening to the wood crackle and pop. My mom asks how we keep the mos

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

quitoes away (lots of tiki torches and mosquito repellant) and says, “Doesn’t it get boring after a half hour?” Again, being the articulate person I am my answer is,

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

“Ummmm, no.”

I try to explain the food cooked outdoors just tastes better. Campfire coffee along with bacon and eggs is hard to beat. And those little S’more make

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

s you can buy in the store are nothing like the delicious S’mores you make over a real campfire. And if you’ve never had a pudgie pie made over a campfire, you’re mi

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

Following aspects would a

ssing out on one of the best camping foods there is! But when I explain to my Mom how good camping food is, she wonders if the bugs buzz around the food we’re trying

dd to the challenges in developing combination products:

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

to eat and asks if I miss my dishwasher. Thanks Mom! My pop-up camper doesn’t have hot water so I have to do things the old fashioned way and heat the water I need

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

to wash dishes.

When it comes to camping though, most non campers could deal with sleeping in a tent or a pop-up camper and wouldn’t mind cooking their food outside

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

. But the one sticking point for many non-campers is the bathroom and shower facilities at campgrounds (unless you’re lucky enough to have a camper with its own bath

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

room and shower facilities). Camping is not like staying at a 5 star hotel. The bathroom and shower amenities take a little getting used to. Some people will wait

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

Professional from academic institutions, pharmaceutical industries, health care indust

as long as possible to go to the bathroom because they want to avoid using the pit toilets at the campground any more than necessary. My sister-in-law doesn’t mind t

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

he pit toilets as much as she minds the spiders that are usually in them.

Camping is what you make of it. Nobody says you have to like it. My Mom doesn’t but I sur

.

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

e do. It’s a way to get away from the daily stresses of your normal life, kick back, relax, and enjoy yourself for a few days. You’ll have responsibilities no more

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

Companies that provide selfless information through particip

taxing than deciding what clothes to wear that day, what to eat, and whether you want to go for a walk or a bike ride or just sit in a chair and relax by the campfire

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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