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The four different Great Chinese Phrases are, "1]The Human Nature is precarious and unstable 2]The True Nature is Obscure 3]Be refined and be One and 4]Be amenable and uphold the center." This is the explanation from Heaven:

1]The Human Nature is precarious and

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

unstable: Mankind is one of the 'Three Powers' in the cosmos. Humans possess 'Li-xing' (True Character), thus mankind is the dominion on Earth. The heart is the center of the cosmos. It governs everything. The Human Nature is senses and emotions. It has been cont

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

Examples of combination products may in

aminated by fancies. It is what being called the nature of the 'Qi-xing' (Spiritual Character) and 'Zhi-xing' (Material Character) in 'Hou-tien' (Space where all lives live after Heaven and Earth were created). It can be good or evil.

If the heart is dominated b

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

y 'Shi-shen' (Spirit of Intellect), emotions and desires are generated constantly. It is half 'yang' and half 'yin', so it can be good or evil. It is not centered. If it biases toward 'yang', one cannot concentrate. If it biases toward 'yin', one becomes vague. U

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

nable to concentrate or being vague are dangerous. Therefore, the Human Nature is precarious.

2]The True Nature is obscure: Tao is the origin of Heaven and Earth. It encompasses everything and is also the origin of all lives. The True Nature is wisdom, the true

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

Combination pro

conscience, and the manifestation of the quiescent, pure, mysterious, and bright True Self. It is what's being called the original Truth in 'Xian-tien' (the Void or Heavenly World). It does not make any distinction between the good and the bad, for its wisdom is

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

full and bright. The True Self is void and quiescent. It is not born nor does it vanish. It cannot be enhanced nor can it be reduced. It is tenuous, mysterious, and cannot be projected. Therefore, it is said the True Nature is obscure.

3]Be refined and be One: B

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

e refined means to be enlightened. Be One means to be sincere. By being refined one can overcome vagueness, By being sincere one can concentrate. Being refined one can be enlightened. Being sincere one can reach Oneness. Once a person reaches this state, he is br

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

ight and quiet, his tranquillity and wisdom flow together and feed each other. This way, his emotions return into his True Self, his knowledge turns into wisdom, his precarious Human Nature becomes settled from danger, and his obscure True Nature becomes bright a

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

nd clear. It is the same as that the enlightened is always sincere, and the sincere is always enlightened. In short, being refined and being One is the technique of eliminating fancies and returning to the Truth, and enlightening to the original bright True Self.

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

4]Be amenable and uphold the center: To be amenable means to obey with faith. To uphold means to return and follow the Truth. The center is the Void and the abstruse existence out of the Void. The Void is so enormous that nothing is outside, and so minute that n

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

Following aspects would a

othing is inside. The existence is abstruse because the existence has no beginning or end. Center encompasses all Three Domains (Heaven of Desires, Heaven of Images and Heaven of Non-Images) and crosses all Ten Directions (North, northeast, east, southeast, sout

dd to the challenges in developing combination products:

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

h, southwest, west, northwest, above, and below). It is the noble path of all Three Domains and the Truth of the Universe. In short, be amenable and uphold the center means to obey the noble path of the center with faith and to return and follow the Truth.

These

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

words are the essence passed on from Emperor Yao to Emperor Shun, King Wen, King Wu, Duke Zhou, and Confucius, the essence that one Saint passed on from one to another with the meeting of their hearts. It is what the five great religions have in common following

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

. It is the Truth that will never change. In conclusion, what has been passed on by the mean of meeting of hearts cannot be analyzed or discussed. It is the true essence of Tao that has been carried among the Patriarchs which originally has no word.

"The Vajra S

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

utra" states, "Subhuti said to the Buddha, World Honored One, if a good man or a good woman resolves his heart on Anuttarasamyaksambodhi, how should he dwell? How should he subdue his heart when fancying thoughts come up? The Buddha said; should 'thus' dwell, sho

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

Professional from academic institutions, pharmaceutical industries, health care indust

uld 'thus' subdue his heart. Anuttarasamyaksambodhi is the True Nature. Fancying thoughts are the Human Nature. 'Thus' is to be amenable and uphold the center."

My Heavenly Master JiGong said, "The National Father Dr. Sun Yat-Sun encouraged people to do the firs

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

t great thing of the underheaven (world); to do great things and not to be a great officer! What is called 'doing great things?' What is great? Only Heaven is regarded as great and only Emperor Yao learnt from it."

The meaning of 'doing great thing' in Tao of He

.

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

aven is "The business concerning the heavy mission of saving human beings back to Heaven." He said that we must do it thoroughly, attentively, earnestly and honestly.

The Essence of Tao described above allows one to realize the True Self and recognize it so that

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

Companies that provide selfless information through particip

one will know how to restore it to its original nature. In the temple of Tao of Heaven, the mission is to let one realizes his True Nature and the initiation of Tao is to awaken it so that he can realize the true meaning of life and the purpose.

Author: T.A Che

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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