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Animism is the belief that all things have spirit and that all spirits are one. There is no separateness, no hierarchy. All spirits are equal, because all spirits are part of the onene

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

ss.

Animism lacks the duality of later belief systems: good/bad, negative/positive, and so on. In animism, values are thought of more as a spectrum from less powerful to more powerful

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

Examples of combination products may in

from less harmonious to more harmonious.

Although many people have never heard of animism, it is the oldest belief system. Shamanism developed from it. Many indigenous people still live in ani

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

mist cultures.

In animism, humans do not consider themselves to be the center of the universe. For example, many animals are stronger, fiercer, faster, or smarter about certain things than hum

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

ns. Many animals can do things that humans cannot, as fly through the air, live underwater, and so on.

Trees are stronger than humans, and they live much longer. Trees have their own spirits a

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

Combination pro

nd knowledge and are revered by many cultures.

Stones are known to be much older and wiser than humans. Their vibrations are not disturbed by ours, but they can affect us.

Mountains have been

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

evered from the earliest times as wise and powerful spirit beings. The same applies to oceans, rivers, lakes, and so on.

Animism Is the Oldest Spiritual Belief System

Animis

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

m is the oldest spiritual belief system known. Anthropologists and archeologists have found evidence for animism dating back at least 70,000 years.

Fully modern, large-brained human beings hav

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

existed for about 250,000 years. Originally humans were gatherers and scavengers. Eventually humans learned to hunt animals instead of just scavenging dead ones.

Until around 10 to 12,000 ye

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

ars ago, all peoples were gatherers and hunters. Many still are. The gatherers, who are the women, generally provide 75 to 85 percent of the food. More in some cultures, less in others.

Anthro

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

ologists know from intensely studying indigenous gathering-hunting peoples that the usual belief system for such peoples, all over the world, is animism.

Animists Are Humble

T

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

Following aspects would a

e oldest peoples were and are very small in stature. Even now there are indigenous people in Central Asia (Nepal), in South America (Peru, Ecuador) and in Africa (the Bushmen) who are under 5 f

dd to the challenges in developing combination products:

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

eet tall and very slightly built. Many animals are much larger, faster, and stronger than they are.

Early humans lived through ice ages when many animals were huge, such as 10-foot-long saber

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

toothed cats and 12-foot tall woolly mammoths. Even after the ice ages ended, large predators such as lions, tigers, leopards, pumas, and bears were much larger and fiercer than humans.

Humans

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

could not run as fast as cheetahs or deer, did not have claws like big cats or badgers, could not fly like a bird or an insect. Humans were humble. They were not the top of the food chain.

Li

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 traditional gathering-hunting peoples today, early humans knew that the animals were their older brothers and sisters. They watched the animals and learned from them by observation and in dre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ams and visions.

Humans knew that the trees were even older and that tree spirits held special knowledge. They knew that the spirits of the stones, the mountains, the rivers, and the oceans we

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

e even older, and that each had its own special knowledge, too.

Receiving Messages from the Spirits

In animist cultures all people pay attention to the messages received in dr

.

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

eams and visions. In order to be in harmony with spirit and with nature, to be happy and to survive, animists pay attention to the messages from animals, plants, stones and other spirits.

Some

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

Companies that provide selfless information through particip

people are naturally much better at communicating with spirits. Eventually some people learned to go into a deep trance and journey to the spirit world to help others. They were the first shamans

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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