Business Dump - Travel and Leisure

Because I do in fact enjoy socializing with expatriates such as myself, I have become, in a way, a tourist savant. My neighborhood plays home to several large and glitzy hotels frequented

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

by travelers the world over. Large busses line up outside these hotels, loading and unloading what I can only describe as sightseeing cattle—hundreds and hundreds of similarly-pale individ

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

Examples of combination products may in

als who, like mosquitoes, appear to be drawn to bright lights and sweet beverages. Seeing these groups day after day—in restaurants, around offices, at the bar—I have learned to make a num

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

er of subtle distinctions that I once quite naively overlooked.

Americans are unmistakable. We’re usually the fattest of the whole bunch and enjoy being loud enough so that in case you di

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

not see our hefty guts, you will most certainly hear them. We generally make little effort to learn the language past the words “hola”, “gracias”, and “cerveza” and when do make the effor

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

Combination pro

t to put together phrases, they usually leak out of our mouths sounding butchered and maimed, like they’ve been passed through a hand-powered meat grinder. We bathe in the tubs of excess:

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

our burgers stacked extra high, our digital binoculars donned with super zoom.

In El Cangrejo, hungry taxi drivers love to prey upon American-looking folks such as myself. Beyond just dri

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

ing taxis, these entrepreneurs are also concierges of sorts: able to point you to the finest strip clubs and massage parlors the city has to offer. They’ll present me a smorgasbord delight

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

as if my simple walk to the grocery store was a jaunt through Sin City. “Hey brother,” they always say. “You want to see some beautiful ladies fighting in oil right now?” As I graciously

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

decline, commenting that it is only ten in the morning and I have some grocery shopping to do, they often go for a last ditch effort: “Brother, I can get you all the beer you ever wanted!”

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

Things like ladies fighting in oil and all the beer I ever wanted, are all at the drop of a dime for a tourist like me, and for this luxury, I feel extremely fortunate.

To blend in a bit

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

Following aspects would a

ore, I made myself a list of things which, if avoided, can spare me some embarrassment and help assimilate quicker. First off, asking where another tourist is from is a no no. The second s

dd to the challenges in developing combination products:

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

meone says to me “and where are you from” or “so how are you enjoying your vacation”, they have given themselves away. They refuse to acknowledge that not everyone, even if it may look tha

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

t way a lot of the time, is down here on vacation. Wearing anything obnoxiously touristy, such as mola-stitched shirts or the all-too-original Panama hat is just asking for it as well. Oh,

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

and if you’re from Europe, please don’t wear your Capri pants or racing style velcro shoes, because they’re just about as obvious as strapping a Guinness to your head and singing football

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

hants.

Panama is also seeing a lot of Canadians, whose “ehs” are really getting under my skin. They take up all the space at the bars asking for Labatts and requesting that the bar back c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ange the channel to some meaningless hockey bout. Busloads of Canadians come in everyday asking if it’s OK to eat the lettuce, a question I’ve now come to respond to with “actually no, it’

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

s not OK to eat the lettuce here. It contains salmonella and will start humming away at your intestine if you ingest even a single leaf.”

Having been in Panama for some time now, most wou

.

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

d think I’ve become a local. Most would think I’ve developed a taste for fried hotdogs for breakfast and pickled quail eggs at soccer matches. Most would think I would’ve made lots of Pana

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

Companies that provide selfless information through particip

anian friends by now, my skin thought to resemble a light beige horse saddle. But none of that is true. I may be considered a Panamanian in some respects: but truly, I’m a tourist at heart

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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