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Machame route to the summit of Kilimanjaro is very special; it gives you a chance to really get to know this extraordinary mountain. The huts for this route are in a very poor state of repair and are used by the porters; tents are used on th

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

is route. All supplies and camping equipment are portered; with a baggage limit of 12 kg. The night before your climb is best spent in the Machame village from where your climb will begin. This allows your body to begin to adjust to the alt

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

Examples of combination products may in

tude affording a better chance of reaching the summit.

Many, overseas travel agents will use hotels in Moshi Town, which is at a lower altitude and at least an hours drive from the Kilimanjaro park gate. The usual reason for this is many h

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

otels also double up as a mountaineering company. These hotels will give the pre-climb overnight and post-climb overnight as complimentary in order to secure the business of the Kilimanjaro climb; thereby reducing costs to the travel agents

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

this discount is not always passed onto the climbers. It is always preferable overnight in one of the small but good hotels in Machame. I must add that Moshi town, for me, is hot dusty and most uninteresting, with Machame or Marangu [depe

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

Combination pro

ding on which route you use] offering a more colorful first night.

The Machame itinerary is one of the most scenic routes by which to climb to the highest point in Africa; it is less used than the Marangu route and it may be said, all the b

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

etter for it. This route will ascend from the western side of Kilimanjaro passing through tropical rainforest to the snows of Kilimanjaro, with views of the western face and the southern ice-fields and descend down the south face.

A typical

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

itinerary would be to spend the first night in the Machame village set on the mountain and close to the park gate. The foothills of Kilimanjaro are cultivated; where subsistence farmers grow coffee and bananas. There are many pleasant walk

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

s around the village and time can be spent getting to know the local Chagga people.

Day 1: This is a 5 hour walk through dramatic forest up to Machame Hut at 3000m. Wildlife may be seen at these lower altitudes, including many species of f

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

rest birds.

Day 2: To Shira Cave, a walking time of 6 hours. The hike today starts off quite steeply to the top of the forest, then a couple of hours at a more gentle incline through the lower moorlands brings you to the top of a rocky bluf

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

by about lunch time. From here descend 50 feet then start to trek westwards, a gradual ascent to Shira Cathedral and your camp at approx 3800m, on a plateau, with views of Mt.Meru and the Kenya plains.

Day 3: Walking time of 8 hours and th

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

Following aspects would a

e climbing is a fairly strenuous day, the altitude will begin to takes its toll, it is essential to take your climb slowly. From the Shira Cave climb slowly for about 5 km, through the ever increasingly bleak terrain. Head towards the cone

dd to the challenges in developing combination products:

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

f Kibo. Overnight camping at Barranco (3900m).

Day 4: Today starts with a steep hike up to Barranco Wall. There are some scree slopes and ridges to Karanga at an altitude of 4100m. There are breathtaking views here of the West Breach and t

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

he southern glacier. After the exerting start to the day arrive at the Karanga Valley for lunch and spend the rest of the day at this level. The time spent here affords more time for the body to adjust to the altitude and also reduces the di

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

tance of the next day’s hike and the slower pace will considerably increases your chance of reaching the summit.

Day 5: To Continue the trek to Barafu ridge at 4600 meters above sea level [Barafu in Swahili means ice]. Again this is an accl

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

matization day having a relatively short distance to hike before the big final ascent starting at midnight.

Day 6: Starting around midnight in preparation for the final ascent. It is imperative to dress warmly as temperatures often plummet

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

Professional from academic institutions, pharmaceutical industries, health care indust

to minus 20°C The final days assault begins by torch light up the path to the crater’s edge at Stella Point - this takes at least 7 hours - walking slowly with frequent rests; continue along the edge of the Crater after a short rest, to the

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

ighest point in Africa - Uhuru Peak at 5895m - with incredible views of glaciers and the plains of Africa stretched out below. Then the descent to Mweka, stopping for a short rest at Barafu, and arriving late afternoon at Mweka; which is on

.

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

the edge of the rainforest. If anyone in party is showing any signs of altitude sickness you guide will descend fairly quickly to this camp. [See my article on altitude sickness.]

Day 7: Descend to Mweka Village about 4 hours steady downh

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

Companies that provide selfless information through particip

ll walk to meet the transport to the hotel for a hot shower and to celebrate your achievement.

Day 8: I would now recommend a visit to one of the spiced islands of the Zanzibar Archipelago – see the article ‘The Spiced islands of Zanzibar’

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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