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Few times in my life have I so physically felt the collective void of a people vanished, the expectant silence that hangs over the empty houses of a missing population. Once was while wandering through the empty barracks at the Dachau concentration camp in Germany, and the other, walking through the largest and best preserved ghost town in all of Asia minor – Kayakoy, Turkey.

Once a thriving Greek village, this town of over one thousand houses, two churches, fourteen chapels, and two schools, was

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

completely deserted in 1923 when the 25,000 Greek inhabitants living there, along with more than a million other Greeks living throughout Turkey were repatriated to Greece through a massive government mandated population exchange between the two countries following the Greek war of independence. Since then, the village of Kayakoy, as it is called in Turkish, or Karmylassos, as it was called in Greek, which had been continually inhabited since at least the 13th century, has stood empty and crumbling

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

Examples of combination products may in

with only the breeze from the mountains and mist from the sea blowing through it's empty houses and streets.

Historically, Turks and Greeks had lived together in this region for centuries, the Turks as farmers in the Kaya valley and the Greeks living on the hillside dealing in crafts and trades. A Greek presence in this region goes back for centuries. The ancient Greek historian Stravon (66 BC - 23 AD) mentioned this region when he stated that "one reaches a steep and difficult place; karmylessos

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

is located here along a narrow and deep river...".

I visited Kayakoy as a part of a cruise on a small Turkish yacht called a 'gullet', which is usually chartered from between one day to a few weeks for a very reasonable price, to sail along the Turkish Mediterranean coast, carrying tourists to all of the prominent archaeological sites, villages, and beaches along the way. Members of my extended family and I this year had undertaken a ten day-long family trip heading east out of the Southern Turki

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

h town of Fetiye, and had been sailing and sleeping on the gullet for about 3 days, alternately playing in the water, wandering small fishing villages, and posing for pictures by ancient Greek statues. On one particular bright and sunny morning, we awoke to learn that we were anchored in a small bay just outside of the tourist beach town of Oludeniz. After breakfast, we all went on a minibus tour of the surrounding Lycian tombs, amphitheaters, and other ancient ruins in the area (Lycia was an ancie

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

Combination pro

t people, language, country, and province of the Roman Empire that lies today in the Antalya Province on the southern coast of Turkey.) Our tour guide then asked us if we had enough energy (and lira) to visit a nearby Greek ghost town. A small, curious, energetic number of us volunteered, and we piled into the minivan again to head up a mountain, and down the other side into a small, steep, green valley overlooking the sea.

Upon entering the valley, I immediately noted the small, gray-stone houses

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

and chapels with faded white roofs spread out over the hillsides against the backdrop of a large dark mountain. The houses were similar in architecture to those I had seen on many previous trips to the Mediterranean, picturesquely clinging to the hillsides of the Greek isles. They were laid out like a hand of cards, with each house strategically placed so that one didn't obstruct the view of the other, and the vast valley unfolded below them with two large dome-roofed churches and clusters of smal

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

er one-story dwellings. The village was larger than I had expected, only having the small mining ghost-towns of my native western U.S. to compare it to, and I immediately pictured the hundreds of empty rock-lined yards filled with colorful clothes hung out to dry, the empty streets lined with old mustachioed Greek men with cigarette's in their wildly waving hands pausing only to drink a cup of thick black coffee.

I couldn't wait to see more, and stepping out of the minivan my brother and I started

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

up into the hillside to explore. We passed by side streets with empty shops, the windows long since broken or looted, where merchants must have once bartered, bought and sold their wares, and housewives argued over the price of eggs or tomatoes. There were old faded street signs in Greek and in Turkish, and small open-doored chapel's with walls laid bare of any iconography, and only a hint here and there of a bowed saint or a winged cherub that hadn't either faded or washed away.

We headed first

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

towards one of the two large cathedrals in the main square, its dome towering over everything else, and found the inside as sparse as the rest of the village. Most of the walls were a pale blue, with the faint outline of a few old frescoes in the upper reaches of the dome, and a beautiful but faded and crumbling mosaic in the entrance-way like a half-finished jigsaw puzzle. The stained glass windows were all either broken or entirely missing, and in the echoes of our footsteps, I couldn't help but

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

icture dozens of little old Greek ladies dressed in black, shuffling across the floor through clouds of incense to light their candles beneath the icon of a saint.

Moving back out onto the main plaza, we looked above the city at the upper reaches of the hillside, where a lone windmill tower, its arms long since fallen off, stood out against the sky. We made this our goal, and started picking our way through the narrow streets, peeking in here and there at the houses on our way up. Most of the them

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

Following aspects would a

were one or two stories, each level having only one or two rooms, where the ground floor was often without windows, and seemed to have been used as storage space. There were empty cisterns at the entrances to most of the houses, where the villagers must have collected rainwater to supplement water from the valley. Since we saw no pipes, it also must have served as an aid to women who would have otherwise had to walk all the way down the hill and back up again to get fresh water. It appeared that t

dd to the challenges in developing combination products:

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

e top of the cisterns in some of the houses were also used as living areas or patios where there were remains of a few small fire-pits, and kleftiko's (Greek clay ovens). The roofs had been made out of wood that had had long since decayed and fallen in, so that light streamed through the whole house, and almost a century of the elements had washed away almost any traces of human life.

Once at the top of the hill, we climbed up onto the windmill, and looked out to our left, to the mountainside runn

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

ing down to the sea, and to our right, to the village running down the hillsides to the green valley with our minivan below. The spectacle made me catch my breath, as I felt a physical weight of the absence of the people who had once lived there. The houses stood out against the mountain like large tombstones in an oversize graveyard, and an empty, expectant feeling hovered over the village, as if it was waiting for something to happen – for someone to sing a song, for some music to start, or for s

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

meone to begin dancing. I couldn't help but think of the thousands of people who had lived in the village for generations, all of them uprooted in a matter of months and sent off to a homeland that they had never set foot in. I found out later that most of the people who had been transferred from this region of Turkey had ended up in refugee housing in a small, poor suburb of Athens, and had remained part of the poorer class of Greece to this day. The Turks who were transferred from Northern Gree

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

e into this part of Turkey were so unaccustomed to its climate and living conditions, that they abandoned Kayakoy within the first year and migrated to other parts of Turkey.

My brother and I started the long walk back down to the valley in response to the honking minivan and waving relatives that signaled it was time for us to leave. On our way down, near the bottom of the valley, we quickly stopped at the second large cathedral, and saw some recent renovation work, which from the sign out front,

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

Professional from academic institutions, pharmaceutical industries, health care indust

indicated that it was being undertaken by the Turkish tourism authority as a part of a "peace and friendship" initiative between Turkey and Greece. Once again, the walls were empty of frescoes except in the highest reaches, where the plaster hadn’t yet fallen away, and the mosaics on the floor were being re-assembled into their original Alpha and Omega shapes.

Before leaving, I stood in front of the cathedral in a grassy square with the ruins of Kayakoy all about me, listening. The silence was ee

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

ie, almost palpable, and somehow different from the quiet one hears while visiting ancient Greek, Roman, or Lycian archaeological ruins. The voices of the dead were not as distant, and I felt as if the moment we left, the inhabitants might come out of their hiding, and a woman with a water-jug or a boy with a donkey would suddenly appear on the streets, about their daily business. We packed back into the van and started heading back up the winding mountain road through the pine trees, and as the

.

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

village was passing out of sight I asked our driver if he knew whether the Greek descendants of the people from this village ever came back to visit. "From time to time" he said "we will get a small group of tourists from Levissi" (the town outside of Athens where most Greeks from this region were re-located to), "but for the most part, the older people have all died, and no-one remembers it."

Although most of what I saw during this trip to Turkey has long since faded into a blur of almost indisti

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

Companies that provide selfless information through particip

guishable beaches, ruins, and fishing villages, frequently confused with others I’ve seen in Greece, Jordan, or Italy, I know that I, for one, will always remember the Greek ghost town of Kayakoy.

If going to Kayakoy, you can find local tours from the town of Fetiye, Oludeniz, Kash or any of the surrounding tourist areas.

http://www.kayakoy.net/kayakoyeng.html

http://www.pbase.com/dosseman/fethiye

http://www.echotrips.com/international/turquoise-coast.html

http://www.kayakoy.net/kayakoyeng.htm

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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