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There are five unique but interconnected laws that describe and define the creation, maintenance and transformation of all of life. To know, really know, these laws requires that you step beyond the conventions of your culture and reach out to a bigger perspective. There is no chaos, there is only a circumstance we cannot understand. These universal laws take you a long way to the u

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

nderstanding you may be looking for.

The fifth law. The law of the one and the many.

There is one universe and many religions that describe it. There is one spirit within you and many ego personas that express it. There is one leader in any organization and many people who are employed to manifest it. There is one love in the human heart and many emotions that come to express it.

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

Examples of combination products may in

There is one humanity on earth and many diverse cultures that fragment their uniqueness to celebrate it.

There is one sun in our sky, and many planets that are obedient to it. There is one government in our country and many laws to govern with. There is one ocean on our planet and many rivers to feed it. There is one earth and many mountains to divide it. There is one creation and

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

many people to evolve it. We live beneath an umbrella. We can rise to the top of one heap, but only find we are now at the bottom of the next. We are always humble to the law of the one and the many.

You have many personas. Many ego identities. Some you hide, some you display. Characters you play. If you add the characters you hide, to the characters you display, to the characters

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

you live in virtual reality to the characters you express in reality, you will find you are the one. We are the sum of the parts, and the sum of the parts is one. We are not different to anyone. We are all the same. Expressed uniquely in the way we demonstrate our fragments, but completely identical if we add those parts to become one.

The ego thinks it is the one, but it is a mere

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

Combination pro

fragment. An emotion. The ego thinks it is separate to others and therefore unique. The ego thinks it can change but it cannot. The ego is a fragment, the spirit is the whole. Spirituality is to know that you are whole, one total being with many fragmented parts. Each of them incomplete, each of them worthy of love.

The forth law. The law of appreciation

What you appreciate gets b

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

igger, what you don’t appreciate gets smaller. Appreciation builds, evolves and creates harmony. Lack of appreciation motivates self consciousness, self depreciation and self destruction. There is nothing to change, only something to appreciate. You cannot change, you can only appreciate yourself as you are. Appreciation is an attractive force, depreciation is a repulsive force.

Fr

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

om the vantage of the one, we see ourselves as many parts. Pain and self consciousness causes us to lose the perspective of the one, and fall into the many parts. Then, we cannot appreciate who we are, we try to change it. Anything we try to change has power over us, anything we appreciate we have power over. If you appreciate your lovers faults, they are not faults but beautiful as

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

ets. If you criticize and try to change someone, you are below them, they have power over you.

You have no fault. You are not broken. Neither is the world or your lover. There are something’s you might not appreciate. The problem is not with the thing, the problem is with your inability to appreciate that thing. Once you appreciate things, then they have no power over you. You are

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

free. This is talent of a great lover. And the talent of the greatest Gods. They appreciate you.

The third law. The law of Abundance

There is nothing missing. It just changes in form. You have every character trait, some you express at work, some at home, some in virtual reality, and some in reality. You are everything you see and everything you dream. There is nothing missing in

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

ou or your beloved. Your judgements are false, they are your ego.

To separate yourself from others means you can criticize and blame them. But there is no them, there is no you. You are everyone you see, nobody outside of you is doing more to you than you do to yourself. You are not unique. You are, like everyone else. You have every trait, every characteristic. Delusion tells you

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

Following aspects would a

that you can change or be different. Maybe you think you can be better than others, but in this one thought alone you prove that false. You are everything, and connected to everything.

There are five elements, Ether, air, fire, water and earth. All the universe is made of these five elements. So are you. There are varying degrees of each and this causes individual differences. But

dd to the challenges in developing combination products:

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

they are one soup. They are just energy in different states, different forms, you have them all, in varying degrees. You are, like the universe, complete. Matter evolving from earth to ether. Nothing is ever missing, it just changes in form. We are all shy. Some at work, some at home, some in regard to money and some in regard to change. We are all shy, nothing is missing.

The sec

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

nd law. The law of growth.

Chaos causes change. Chaos stimulates challenge and confronts the status quo. Chaos breaks deadlocks and promotes change. Order on the other hand rests us, gives us time to absorb and digest, to take it all in, to master our space, to become good at what we do.

Too much order and we stagnate. Too much chaos and we burn out. Growth occurs at the border be

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

tween the two. The purpose of love is growth. Love is both chaos and order. Growth means to convert chaos to order. Chaos is what we don’t appreciate. Growth therefore means to convert those things we don’t like into those things we do like. That is how we get more love. We take what we don’t appreciate (called chaos) and turn them into things we do appreciate (called order)

In a r

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

lationship there is a perfect balance of support and challenge. Challenge is chaos (things we don’t appreciate) and support is order (things we do appreciate). When we first meet our lover, there are more things that we appreciate than we don’t appreciate. This is called infatuation. After some time there can be more things that we don’t appreciate (challenges) than we appreciate (s

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

Professional from academic institutions, pharmaceutical industries, health care indust

upport). Then we resent our partner and want to leave. But the truth is that there is always a perfect balance of support and challenge in life. We were just blinded in the beginning.

The first law. The law of balance

There are two sides to every coin. This is how we convert issues we don’t appreciate to issues we do. How we turn chaos to order. We see the other side of the coin.

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

There is always a silver lining in every cloud. So, there are always two ways to see things. One way is to see the dark, the other way is to see the light. The wise person sees both but then focuses their mind on the light. The emotionally disturbed person tries to eliminate the dark, thinking it will go away.

For every thing we move from dark to light, a new balance is created. So

.

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

the more light we see, the more happiness we have, the more fun, the more peace, then, the more dark, the more sadness, the more un-fun, the more drama we have. Duality is the cause of emotion, and there cannot be an upper without a downer.

To break the mould means to see two sides. For example in our western culture you might say laziness is bad. But in the Spiritual Culture, lazi

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

Companies that provide selfless information through particip

ness might be exactly the same as mindfulness. Or contentment. In the west we see inspired and enthusiastic as good, in the Eastern language we might call those same behaviours running away, unable to be in the moment, lacking stillness. There are two sides to everything. Relabel those things you don’t appreciate. Find the blessing in them. They can’t be eradicated, only appreciated

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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Most inexperienced entrepreneurs are unaware of the many options and alternative strategies available to push a new idea or invention to market. The most common approach they seek to implement is a classic funding round. When this avenue fails, and with overwhelming frequency it does, the idea often is dropped. There are other opportunities and strategies available for successfully getting a great idea to market. The bar for acquiring venture capital funding is so high, so difficult and so competitive, that it is unfortunate how many inventors quit the pursuit of their goal after receiving no traditional funding commitment. One of several alternatives to venture funding is a license campaign.

On an introductory call, your voice is your instrument. During a face-to-face meeting, you have visual cues and body language available to add layers of meaning. On the telephone, you have only your voice and the words that you use. The way that you use your voice can make or break your conversation.

You need passswords to get by call sentries, says telemarketing expert, sales, service, and success coach, and President of Customersatisfaction.com, Dr. Gary S. Goodman. The secret, says this popular keynote speaker and radio and TV expert commentator, is to volunteer information before doing anything else, to show you deserve admittance.

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