Social Space - Travel and Leisure

Everyone loves to travel (almost everyone). I certainly do. Believe it or not, doing it right and doing it on a budget takes a little skill, knowledge and practice. But the required skills are not difficul

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

t, the knowledge required is easy to obtain, and the fun is in the practice!

This past spring my wife and I were lucky enough to be able to spend 10 days in Italy. We didn't spend a fortune, we scrimped o

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

Examples of combination products may in

a few things and spent on others, and the net result was a very pleasing travel experience. Planning, of course, is key. We had agreed to our general itinerary and had a limited amount of time to spend, so t

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

he general outline of the trip was pretty clear from the start. We flew to Rome, spent a few days taking care of the biggies like St. Peter's, and the Vatican Museum, and did lots of strolling around the city

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

Where did we stay? At a "budget" hotel. How did we find it? The Internet. There are so many choices of reasonably-priced hotels, that the biggest problem is narrowing down the list. If you have even m

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

Combination pro

inimal Web-surfing skills, finding your accomodations this way is really pretty easy to do. Many establishments even offer a discount for reservations made online. Oh, by the way, when we paid the bill on t

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

e way out, we paid in cash - another discount!

How did we get from the airport in Rome to the hotel? (Hint: not by taxi.) We took the train! Much cheaper, more fun, and in fact, easier. Even if you can't a

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

ctually read the signs in the airport, finding the station is very easy. How did we really know it was so easy to get to the city from the airport on the train? We cheated. We read a travel guide before we

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

left! I'm not pitching a travel book here, and I honestly don't remember which one it was, but the point is, a little research in advance can save you a lot of money, time, aggravation, fear, uncertainty a

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

nd all those other negative emotions brought on by arriving in a foreign place and suddenly realizing you have no idea what to do next. And finally, from the train station in the city to our hotel was a sho

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

t walk because we planned it that way - no taxi fare. The walk to the hotel was made even more pleasant by the fact that we were not over-burdened with luggage, which brings us to the next practical tip - pa

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

Following aspects would a

king.

Ten days in Europe (or anywhere else) doesn't require a mountain of baggage - at least not for two adults. Bags with handles and wheels are essential. Walking to the hotel with our luggage was a bree

dd to the challenges in developing combination products:

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

ze. Packing, like the other parts of a trip, requires a little planning. If you're careful, and are clear about your plans for touring and socializing, you can get by with less than you think.

Keeping your

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

ravel documents and money secure is always a concern. I learned an important lesson a few years ago during a trip to Europe. Having done a lot of business travel all over the world, I made the mistake of thin

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

king I was immune from pick pockets. I won't mention the city the event took place in, but afterwards I was stunned at the skill demonstrated by the "team" that got my wallet - out of a jacket pocket that wa

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

zipped closed! It happened in a revolving door - and thinking back on the episode, I realize that I was expertly sized up for the "hit" beforehand. In short, realize that anyone can be "fooled" even if yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u think you're an expert. Lesson - I NEVER travel now without a money belt. On our last trip to Italy, all valuables were in the money belt at all times, and there were no incidents. Even the "gypsy kids"

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

t the Coliseum were not a threat (if you go to Rome, be sure to read about the area around the Coliseum - you must see it, but it's prime territory for expert young thieves).

In summary, a little thought a

.

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

nd some careful planning can make a huge difference in the level of pleasure you derive from your next trip - whether it's a European jaunt or a car trip with your whole family to the mountains. I think lett

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

Companies that provide selfless information through particip

ng someone else do it all and spending your days sealed up in a tour bus or following someone else around all day deprives you of half the fun. So plan your next trip carefully and you'll enjoy it a lot more

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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