Summary - Relationships

Every year I take small groups of people to these sacred lakes. They go to find a deeper essence of life, to renew their individual commitment to authen

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

ticity. People sit by those lakes and dream, and there is no ego involved. Ego falls off on the way up. These lakes are a place where, legend has it, t

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

Examples of combination products may in

e power of prayers are multiplied by thousands upon thousands, a place where dreams that are dreamed, come true. And for me that has always been the cas

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

.

Now, here in this chapter I am going to share what I know about a vision quest you and your lover can do together. But before I do, I am going to sha

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

e some don’ts.

1. Don’t be afraid. There is a wisdom far greater than the one you know as your mind. Let the dreams come, let them fly on the wings of

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

Combination pro

ove, and let them sit. Allow them a home, a resting place, because those dreams have been waiting for you to arrive. Let them find you, that is enough.

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

2. Hold those dreams sacred, share them with your beloved. Allow no soul to condemn, question, advise, interfere, compromise or criticise them. Prevent

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

ourself from judging, or having the mindset to ask how, or why. Those two words kill the spirit of a dream.

3. Practice dreaming without action. I woul

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

like to share an example. You have a mother, look up from where you are seated now, and see around you one thing that reminds you of her. Then come bac

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

to this page and read on. Did you think, “What should I find?” Did you ask, “What sort of object?” Did you immediately find something, but it didn’t s

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

em right so you rejected it? This is the ego. That is why vision quests need to be learned. Eventually you will learn to hold your mind empty and allow

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

Following aspects would a

our intuition to make choices without good reason.

4. Don’t dream about how you want to feel, who you want to become, how you want to change yourself.

dd to the challenges in developing combination products:

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

ll this comes from judgment, and that judgment is from your mind. Dream only of doing. What would I love to do? This is the only area where spirit can g

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

ide you. Who you are, and who you become is irrelevant to a vision quest. Only your ego cares about that.

5. Always ask. Don’t force the answer. Don’t

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

udge the result. Be thankful for the opportunity you have to hear. Avoid wanting anything. Ambivalence is the state of mind in which inspiration will co

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 to you. Just be open.

6. Remove all your hopes. Most blockage in visioning comes from wanting. Wanting to be peaceful, wanting to be loving, wanting

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

Professional from academic institutions, pharmaceutical industries, health care indust

o be nice, wanting to be spiritual. Wanting is blockage. True visioning means, “Whatever it takes, I will follow the guidance I get”.

7. Don’t be bluff

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

d by others. These days, self-help language is freely available, gurus abound, spiritual teachers are many, bookshops are filled with anything from how

.

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

o hurt people (turn your boyfriend into a frog), to how to call down an angel. It is hard to know people now, because we have so much language. People c

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

Companies that provide selfless information through particip

n talk the talk, but can they walk the walk? Walk the talk. If you want to really know a person, see what they do, and how they do it. All else, is myth

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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There they are again, the odd, three-letter acronyms. I find them scattered throughout copy or under the waterfall of a swatchbook. They show-up everywhere … PCF, TCF, ECF, PCF, TCF, ECF. Enough confusion. I'll just call the mill’s sample department. They'll know.

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