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Delicious - Mount Chimborazo: Climbing Glaciers Near The Equator
The climb up the glaciers to the summit of Mount Chimborazo in Ecuador isn't considered highly technical. Technically, it is mountaineering, but how hard could it be, considering that I went to 20,600 feet the first time I used crampons and an ice axe? Okay, I had used them once for practice, on a sledding hill near my house. I climbed alm
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
ost forty feet while people walked by with their sleds, warning their kids to stay away from me.
Driving Up Mount Chimborazo
It is easier to climb a mountain when the guide drives you to 15,000 feet. Don't get me wrong. Climbing that last 5,600 feet was one of the most difficult things I've done, but not for the skill re
It is easier to climb a mountain when the guide drives you to 15,000 feet. Don't get me wrong. Climbing that last 5,600 feet was one of the most difficult things I've done, but not for the skill re
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
quired. The fact that the air was missing half of its oxygen is what had me quitting twenty or thirty times on the way up Chimborazo. It just gets difficult to move up there.
The Graveyard
The little monuments near the first refuge weren't for climbers without skill. The graveyard is a testament to the unpredictability
The little monuments near the first refuge weren't for climbers without skill. The graveyard is a testament to the unpredictability
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
of all high places. Chimborazo is very high, it randomly drops large rocks on you, and has weather that changes by the minute. Even as we were hiking to the second refuge, we could hear the rocks and pieces of ice falling somewhere above.
El Refugio Edward Whymper is a simple, unheated hut at 16,000 feet, named after the English climber who firs
El Refugio Edward Whymper is a simple, unheated hut at 16,000 feet, named after the English climber who firs
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t made it to the summit of the mountain. Okay, it isn't entirely unheated. There is a fireplace, and when somebody feels like carrying wood up to 5000 meters, the fire might raise the temperature in the hut by 3 degrees.
We had "mate de coca" a tea made of coca leaves, which are also known for another product made from them--one that is taken up
We had "mate de coca" a tea made of coca leaves, which are also known for another product made from them--one that is taken up
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the nose. Then we went hiking for a short while. That was my acclimatization. We ate, and I slept for at least an hour before starting the ascent at eleven that night.
A Little About Mount Chimborazo
Chimborazo is in Ecuador, not far from the Equator (100 miles south). The elevation in the center of the country, and the
Chimborazo is in Ecuador, not far from the Equator (100 miles south). The elevation in the center of the country, and the
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
moderating effect of the Humboldt Current, which runs along the west side of South America, gives the country near perfect weather. A bit hot along the coast and lowlands, but spring--like in Quito (the capital) , with daily highs in the sixties to low seventies year--round. Wonderful weather almost everywhere--until you get high enough.
Chimb
Chimb
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
razo, at it's peak, is the furthest point from the center of the Earth. Our planet bulges at the equator, making Mount Chimborazo even futher out there than Everest. It has the distinction of being the closest point to the sun on the planet, and yet still the coldest place in Ecuador.
Climbing Chimborazo
Paco, my guide,
Paco, my guide,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
didn't like the lightweight part of this mountain climbing adventure. He frowned when he saw my sleeping bag, which packed up smaller than a football, and weighed a pound. My frameless backpack didn't seem to impress him either (13 ounces). In any case, although it did get below freezing in the hut, just as he said it would, I stayed warm--as I s
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
aid I would. No problems so far.
Unfortunately, Paco didn't speak a word of English, and I was just learning Spanish. Since our whole group consisted of him and me, we did have some communication problems. I thought, for example, that the $11 fee for the "night" (a few hours) in the hut was included in the $130 guide fee. He thought that I was a
Unfortunately, Paco didn't speak a word of English, and I was just learning Spanish. Since our whole group consisted of him and me, we did have some communication problems. I thought, for example, that the $11 fee for the "night" (a few hours) in the hut was included in the $130 guide fee. He thought that I was a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
mountain climber.
I think he was saying that he didn't like the papery rainsuit I was using as a shell, and he frowned at my homemade 1--ounce ski mask. When he saw me putting on my insulating vest, a feathery piece of poly batting with a hole cut in it for my head...well, I just pretended not to understand what he was saying.
I hadn't intende
I think he was saying that he didn't like the papery rainsuit I was using as a shell, and he frowned at my homemade 1--ounce ski mask. When he saw me putting on my insulating vest, a feathery piece of poly batting with a hole cut in it for my head...well, I just pretended not to understand what he was saying.
I hadn't intende
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
d to go climb up Mount Chimborazo with such lightweight gear, but I had come to Ecuador on a courier flight, and could bring only carry-on luggage. Since I had only 12 pounds in the pack to begin with, by the time I put on all my clothes that night, the weight on my back was irrelevant. The weight of my body, however, wasn't irrelevant. Paco had
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
to coax me up that mountain.
Hiking On Glaciers
The glaciers start a short walk from the hut, and hiking soon became mountaineering. I put on crampons for the second time in my life (there was that sledding hill). During one of my many breaks ("Demasiado" - too many, which I pretended not to understand when Paco explaine
The glaciers start a short walk from the hut, and hiking soon became mountaineering. I put on crampons for the second time in my life (there was that sledding hill). During one of my many breaks ("Demasiado" - too many, which I pretended not to understand when Paco explaine
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
d in Spanish), I noticed that the tiny, cheap thermometer I carried had bottomed out at 5 degrees fahrenheit. I wasn't cold, but I was exhausted at times--the times when I moved. When I sat still I felt like I could run right up that mountain.
We struggled (okay, I struggled) up Mount Chimborazo, hiking, climbing, jumping over crevasses, until I
We struggled (okay, I struggled) up Mount Chimborazo, hiking, climbing, jumping over crevasses, until I
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
finally quit at 20,000 feet. Of course I had quit at 19,000 feet, and at 18,000 feet. Quitting had become my routine. Lying had become Paco's, so he told me straight--faced that the summit was just fifty feet higher. Maybe I wanted to believe him, or maybe the lack of oxygen had scrambled my brain. In any case, I started up the ice again.
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
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
r>On Top Of Mount Chimborazo
We stumbled onto the summit at dawn. Well, okay, I stumbled. Paco, who seemed somewhat frail down at the refuge, was in his element at 20,600 feet. Dirtbag Joe, the nineteen-year-old kid from California with ten dollars in his pocket, borrowed equipment, and my Ramen noodles in his stomach, was waitin
We stumbled onto the summit at dawn. Well, okay, I stumbled. Paco, who seemed somewhat frail down at the refuge, was in his element at 20,600 feet. Dirtbag Joe, the nineteen-year-old kid from California with ten dollars in his pocket, borrowed equipment, and my Ramen noodles in his stomach, was waitin
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
g for us with a smile.
The sky was a stunning shade of blue that you actually can never see at lower elevations. Cotapaxi, a classic snow-covered volcano to the north, was clearly visible 70 or 80 miles away. Handshakes all around, and it was time to get off the mountain. I was told you don't want to be on Mount Chimborazo when she wakes up. She
The sky was a stunning shade of blue that you actually can never see at lower elevations. Cotapaxi, a classic snow-covered volcano to the north, was clearly visible 70 or 80 miles away. Handshakes all around, and it was time to get off the mountain. I was told you don't want to be on Mount Chimborazo when she wakes up. She
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
wakes up at nine a.m.
Paco kept looking at his watch and frowning. He told me to hurry, then he got further and further ahead. I thought he was going to abandon me on the mountain. When I finally caught up to him at the hut at nine a.m., I began to hear the rocks fall out of the ice above as the sun warmed it. Now I understood his concern with
Paco kept looking at his watch and frowning. He told me to hurry, then he got further and further ahead. I thought he was going to abandon me on the mountain. When I finally caught up to him at the hut at nine a.m., I began to hear the rocks fall out of the ice above as the sun warmed it. Now I understood his concern with
.
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
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
time. We really did need to get down to the refuge by nine. A thousand feet lower and my mountain climbing adventure ended with a photograph that mercifully doesn't show my shaking knees.
NOTES:
If you want to climb Mount Chimborazo, it is cheapest to wait until you get to Ecuador to make arrangements. Talk to almost any hotel owner or manager
NOTES:
If you want to climb Mount Chimborazo, it is cheapest to wait until you get to Ecuador to make arrangements. Talk to almost any hotel owner or manager
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
in Riobamba, and he or she will find a guide for you. It will be cheaper if you are part of a group, of course.
For more information and stories about Ecuador, you can visit the pages, "Information On Ecuador," and "Banos Ecuador" on the website http://www.EverythingAboutTravel.com
For more information and stories about Ecuador, you can visit the pages, "Information On Ecuador," and "Banos Ecuador" on the website http://www.EverythingAboutTravel.com
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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