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Recently a young college sophomore wrote to ask me for help. In part, she wrote, "My name is Jaimie and I am a sophomore in college. I wrote you perhaps a year ago (not that I expect you to remember) and noted that your Layers of Aloneness Theory could be paralleled to religion in many aspects

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

. I am writing to you now because I have been quite depressed for a while. I have felt this way on and off for several years, but it does not usually stay this long at a time. I am not happy with myself nor with my life and would really like to be happy again. I suppose I am just asking for advice

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

Examples of combination products may in

on depression and where to look for help without using drugs."

This was my reply.

Hi Jaimie,

Well, I do remember; you made me smile with your suggestion that I might be reconciling science and spirituality. Something like that.

As for some suggestions, you offer some clues to some pretty

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

good starting places in what you wrote.

[1] I have a lot going on inside my head most of the time and it feels like a large mess. Here is where I would begin. And often have in the past. Thus, when my head gets filled with too many ideas, I transfer what is in there to something out here

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

. Something physical. Like a list. Perhaps 3x5 cards. Perhaps on a pad. Or perhaps write a worry list and put it in a God Box. Something physical. That is where I would start.

My point? Making your problems visible is the first step toward solving them. Even if you believe you know perfectly well

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

Combination pro

what your worries are.

Why does this help? Because no matter what anyone tells you, we live in two worlds. A physical world and a non physical world. Worries in your head live in the non physical world. Writing them down completes their entry into life.

Sound too metaphysical? In truth, it does

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

not matter. You see, all that matters is that you try it and see. If it helps, then great. If not, then try the next thing.

What you might also do here is, try to notice if, as you consider this idea, you feel intellectually resistant to "physicalizing" your worries. People who feel depressed oft

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

en feel this resistance; literally they hope their depression will go away if only they ignore it long enough. It doesn't, and you feel worse over time. Why? Because depressions are like molds. They grow larger when you keep them in damp and dark places. Damp and dark is teary and inside you. Even

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

if the tears never make it to the surface.

[2] Is the help of a therapist necessary? This depends on whether you, yourself, are willing to go down the road spiritual masochists like me go down (smile). What I mean is, many of my discoveries in and around human nature came directly from

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

hat I was too stubborn to ask for help. Or too afraid to open up. And while I have, indeed, authored much good work, I no longer choose to travel this road alone.

What I am saying is, there is no real substitute for a qualified professional. Unfortunately, many professionals focus more on symptom

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

relief than on restoring visual normalcy. Even in these cases though, you can be helped simply by sitting on a scheduled day and time across from someone with a good heart. Just don't take everything they say as the "truth." There is no "the" truth." Only your truth. Just the same, you might try

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

Following aspects would a

it.

[3] I am beginning to think that it is because I feel like I have tried to "fix" myself and to no avail. Jaimie, here you are spot on. First because you've failed to fix yourself. Second, because you're lost and alone. First things first.

Failure is the main experience of winners. F

dd to the challenges in developing combination products:

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

w folks recognize this. I, myself have failed more times than I can count. I simple am a stubborn old man who will not risk that I may regret my life as I die.

I also believe all babies are born with a chance to be significant, a chance to be of use to our world. This includes you, Jaimie. The th

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

ing is, we folks with high potentials seem to have very difficult lives at first. However, it you keep seeking and do not give up, you will find your way, your meaning for being here.

My intuition about you. You are depressed in part because you are disappointed in your life. Why? Because you can

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

not be satisfied with an ordinary life. Why else would you be trying so hard to find your way.

This means you need to patiently keep climbing while you search for your faith. Faith in what? Faith in nature. Faith in that we all have in us the astounding ability to do good in the world. Faith in t

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

at goodness is real and we cannot do what we cannot see. If we are meant to be of help then we must do as Buddha did; personally experience the world's suffering. Just try not to mistake this for suffering for "meant to be suffering." It is not "meant to be." In fact, it is only useful if and when

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

Professional from academic institutions, pharmaceutical industries, health care indust

you take this suffering into your heart and use it to do good.

[4] Finally, know that the main way most folks find their way is through good deeds. Focus on finding the needy and give to them. For instance, you are depressed. Volunteer in an old age home and ask them to help you. Sound crazy? It

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

's not. Why? Because the root of depression in most old folks is feeling useless. Thus, if you give an old person a reason to be, you give them back their life.

Of course, I could be saying much the same thing to you, Jaimie. I would bet you feel useless. Thus, give yourself a use and you will fe

.

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

l amazingly restored and alive.

And do hang in. The world so needs folks who can find their way through to the other side of suffering. In fact, we then become the very guides the world is so desperate to have.

I believe in you.

Warmly,

Steven

P. S. You might try looking at the Cycles of Thre

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

Companies that provide selfless information through particip

e articles on the site. They document how I helped myself. And do write and tell me how you are doing, even if you seem to have gone no where. If so, it might be good to remember what the Buddhists say about resistance. When you feel the most resistance, it means you are moving forward really fast

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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