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Camelids are even-toed ungulates: hoofed mammals, distinguished by their elongated double-toed splayed feet. They are m

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

ostly large, plant-eating animals that differ from ruminants, such as cows and sheep, in several important ways: they h

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

Examples of combination products may in

ave a three- chambered stomach (as opposed to four), a divided upper lip with each half separately mobile, a tooth in t

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

e upper part of their jaw that is isolated form the rest, and elliptical red blood cells.

There are four species of ca

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

melids in the Andes: llamas, guanacos, alpacas and vicunas. The indigenous people of Peru and the Andes have bred, deve

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

Combination pro

oped and depended on these animals for centuries.

The two wild species of camelids are the Guanacos and vicu?as. Llam

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

as are descended from Guanacos and Alpacas from vicu?as.

One can observe wild herds of guanacos, (Lama guanicoe,) runn

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

ng freely on the open plains of the Peruvian Andes. They are tall, elegant creatures with long necks and reddish brown

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

double coated pelts. They live in small herds comprised of a male, his harem of females and their young.

The llama (La

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

a peruana) was developed from the guanaco by indigenous livestock breeders over the centuries. Because of the fact that

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

they are taller and stronger than alpacas, they are valued for their abilities as pack animals. They are also distingu

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

Following aspects would a

ishable by their longer head. They are used to a lesser degree for meat and fiber. In western countries, they are kept

dd to the challenges in developing combination products:

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

s pets.

Alpacas (Vicugna pacos) do not carry loads; they have been developed for their fiber and their meat. Alpaca wo

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

ol is highly valued for its softness, lightness and warmth. They are woolly and have a more uniform color than llamas.

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

hey also have straight ears and short tails, as opposed to the "tipped" ears and longer tails of llamas. Their fleece i

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

s washed, spun into thread, dyed and woven into garments, blankets, sweaters, hats, etc.

Smaller and more delicate tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

the Guanaco, the vicu?a (Vicugna vicugna) is the smallest camelid. Their wool is very soft and fine, and highly valued

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

, and, in the time of the Inka, was worn only by royalty. They have recently been downgraded form endangered to vulnera

.

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

le, as their population has increased form around 60,000 to 250,000 animals in recent years. This is due to the success

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

Companies that provide selfless information through particip

of indigenous management programs.

All four species of camelids may be seen and enjoyed in Peru, the Land of the Inka

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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