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You are no doubt familiar with the harmonizing symbol of yin and yang: the mystical circle encasing rolling waves of black and white. Within the black wave rides a white dot, and conversely

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

, a black dot is seen in the white wave. This ancient Chinese symbol has become popular as East opens up to West, and can be seen on billboards, signs, T-shirts, and jewelry around the worl

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

Examples of combination products may in

. Most know its connection to the idea of yin and yang, but few know the origin of yin and yang, or anything more of Taoist thought.

Taoism, as both philosophy and religion, was founded 25

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

00 years ago in China, by Lao Tzu. According to legend, Lao Tzu (born Li Erh) worked in the imperial capital as a record keeper. At 160 years of age he became disgusted with society and vow

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

d to leave. As he approached the gate to the city, Guan Yin Zi, the keeper of the pass, begged him to write his teachings before he left. This Lao Tzu agreed to do, and in one night he wrot

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

Combination pro

the Tao Te Ching, forming the basis of Taoism. Leaving his writing behind him, Lao Tzu was never seen again.

The Tao Te Ching is one of the most infuential books in Chinese literature, an

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

d is among the top three books translated into English, along with the Bible and the Bhagavad Ghita. It is composed of 5,000 characters divided into 81 chapters, originally written on strip

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

of bamboo tied together with string. In these writings, Lao Tzu described the Tao: a flow which was unknowable in essence, but observable in manifestations. To find true peace, one must de

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

elop a mystical relationship with the Tao.

The Tao, literally translated "The Way," exists in both a philosophical and religious form. Both paths teach of yin and yang, or the opposing for

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

ces by which the universe is governed. Yin is negative, female, dark, and earthly; while yang is the corresponding qualities of positive, male, light, and heavenly. Neither is better than t

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

e other; just as neither can exist without the other. (It might be noted that while there are some contradictions within the philosophical and religious forms of Taoism, one might consider

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

Following aspects would a

hem manifestations of yin and yang, with the pure philosophy being the reflective yin side of Taoism, and the religion being the active yang.)

Within the Tao Te Ching is a call to passive

dd to the challenges in developing combination products:

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

action, or wu-wei, for in doing nothing all is accomplished. According to the principles of wu-wei one should not defy, confront, nor resist. Experience teaches that ambition, excessive des

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

re, and pride always produce the opposite of what is expected. Therefore it is better to live like birds, who use currents of air to support them as they glide, rather than fight the drafts

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

In like manner, philosophical Taoists seek to find their own niche in the scheme of things.

Religious Taoism departs slightly from this path of inaction. Approximately 200 years after the

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

death of Lao Tzu, an encyclopedic Taoist scholar by the name of Ko Hung taught that instead of practicing pure inaction, one could force open the path of long life and immortality through

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

Professional from academic institutions, pharmaceutical industries, health care indust

ne's own acts. He believed that just as the interaction of the five elements (earth, wood, metal, fire, and water) produced a balanced universe, so could they be used to achieve physical im

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

ortality. This resulted in the practice of herbal medicines, rituals, magic potions, physical exercises, and dietary practices. Long life and good health were viewed as a reward for good mo

.

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

ral conduct, as disease, death and suffering were evidence of the contrary.

Within China today there are 25,000 Taoist monks and nuns at over 1,500 temples. It is impossible to report the

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

Companies that provide selfless information through particip

umber of adherents to the faith, as Taoism is often intertwined with Buddhism and traditional folk religions. There is no doubt that the effects of Taoism can be felt around the world today

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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