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The Migration

What gives the gnu its worldwide repute is not its body structure however, but the sheer numbers and spectacle created by its migration. The animals migrate between the Serengeti and Mara Savannahs in Tanzania and Kenya re

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

spectively, in search of grass and water. It is estimated that over 1 million of these animals are on the move during the annual migration between June and October.

The numbers are so high that miles upon miles of grassland is blanketed

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

Examples of combination products may in

by a mass of moving gnu. The wildebeest simply stretch from one horizon to the next; of the conveniently flat and treeless Maasai Mara Savannah. It is a sight to behold when on your gnu migration or wildlife safari. The wildebeest migr

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

tion phenomenon is so huge that satellites miles away in space are able to capture the surge as a black moving mass of gnu on the plains of East Africa. Now, that’s huge: and it’s even more awesome watching the gnu on the ground or with

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

ara balloon Safaris. River Crossing The most dramatic and memorable safari experience is when you observe the migrating wildebeest at the several Mara river crossings. Numbers upon numbers of gnu gather at such crossings unsure of thei

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

Combination pro

next move. The crossings are such notorious spots that the gnus have developed a self preservation instinct over time.

Wildebeest/gnus will amass in their thousands at banks of river Mara which is rife with the dreaded Nile crocodile a

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

nd raging currents. Put in the swift current, eminent stampedes and jaw snapping crocodiles in this picture and you get a guaranteed recipe for mass genocide at such river crossings. The Maasai Mara River is usually awash with bloated ma

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

s of wildebeest/gnu carcass that crocodiles feast on for days on end.

Over 250,000 of the wildebeest die from drowning, stampede, crocodiles and the predators every year. But even this annual carnage is not enough to reduce their number

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

. The wildebeest/gnu deaths during migration are replenished by the over 400,000 births a year. The deaths during migration are now considered as a natural population check; natural selection at its best.

Do and Die Point

River crossin

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

s in the Mara are favourite vantage points to observe the Mara wildebeest migration on your Kenyan safari. The animals will gather hesitantly in huge numbers on the banks, unsure of when to take the plunge. The other wildebeest/gnus behi

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

d the frontline keep amassing into hundreds of thousands until the pressure on the front is too much to bear.

They finally take the leap; and when they do, even the waiting crocodiles scatter to the flanks. The fear of being trampled by

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

Following aspects would a

the millions of wildebeest/gnu is too real for even a crocodile to risk a head-on affront. Hundreds upon hundreds of wildebeest make death-daring high leaps into the water that the splash sounds like a million water falls.

The Wildebee

dd to the challenges in developing combination products:

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

t/gnu Predators.

Wildebeest migration is such that a smattering population of other bovids joins in the migration including Zebras and Gazelles. Lion prides also escort (as they eat some gnu, of course) and welcome the migrating wildebe

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

st on either side of the Mara River Crossings. The lions stark up their stomachs with animal carcass to a point that, they are finally subdued by wildebeest with little fear.

As long as a lion has had his 35 odd kilos of wildebeest a da

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

, he poses no threat. “All that is needed is to sacrifice a cousin here, a distant aunt there and we are fine.” It’s surely a game of numbers. Leopards on other hand, don’t have to move far to hunt their prey. All they'll do pounce on un

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

uspecting wildebeest as they pass by their (leopards) tree parches. The rest scatter as usual in different directions. “It’s just another sacrifice after all; we still got the numbers... no matter what. This is one of the most elusive pi

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

Professional from academic institutions, pharmaceutical industries, health care indust

cture-perfect moments when you are on your African Wildlife Safari.

Going for your wildebeest migration in the Mara.

It’s not only the carnivores that will escort migrating wildebeest but humans as well. The Maasai Mara attracts such i

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

terest that the ensuring demand during the months of July -October cannot be met. You will find it difficult to get a space in the lodges if you do not book in advance. Your accommodation in the Mara ranges from 4star to 5star deluxe lod

.

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

es, tented camps and simple Kenya camping tents.

The wildebeest Migration takes place everyday of the 4(July-October) month duration. You are as such guaranteed a sighting irrespective of which month of the 4 you visit.

Your bookings a

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

Companies that provide selfless information through particip

e handled by several professional companies which also provide transportation and transfers from airports, self drive car hire and accommodation in the Mara. Make sure you see the migration the next time you make a Kenyan wildlife safari

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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