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When we find ourselves in the position of being a parent to a child experiencing severe emotional and behavioral problems (e.g., ODD, Conduct Disorder, ADHD, Bipolar), we will either seek strength and guidance from a Higher Power – or we will burnout, get sick and give up. To parent a strong-willed, out-of-control child without assistance from a Power ‘greater than ourselves’ is analogous to rowing up the river without any paddles.

I want to share an important spiritual principle with you: What You Think About Expands. Let me help you wrap your brain around thi

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

s concept.

If you believe, for example, that people cannot be trusted and that they are generally self-serving -- you will find a lot of untrustworthy, selfish individuals showing up in your life.

If you believe that your family will never experience any joy or peace -- you will find a lot of sadness and discontent arriving at your doorstep, not to mention living day-to-day in a near-constant state of depression and helplessness.

If you believe that your son or daughter is destined for a lifetime of failure and misery -- you're right!

Conversely, if you beli

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

Examples of combination products may in

ve that people tend to want to live up to your trust and that they CAN be influenced to change unwanted behavior -- then you will attract numerous individuals who are trustworthy and capable of change.

If you believe that your family and children are a "work-in-progress" and that the best is yet to come -- then you will have patience with the parenting process and will see a constant, loving source of hope and reassurance for the future.

This is not hype I'm referring to here. Rather, this is a natural "law of the universe" ==> What you think about becomes you

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

r reality. We don't know why it works this way, but we have much evidence that it DOES work this way.

Thus, here are the spiritual principles that will help you practice expanding those things in your life that WILL bring you peace, joy and prosperity:

+++++ SPIRITUAL PRINCIPLES +++++

· BREATHE / RELAX / SLOW DOWN / BE EXPRESSIVE / LAUGH

· WHO CAN I BUILD UP TODAY?

· DEMAND NOTHING OF ANYONE TODAY -- REDUCE EXPECTATIONS OF OTHERS

· RELINQUISH THE NEED TO BE RIGHT

· FIRST THINGS FIRST

· KEEP IT SIMPLE & BE HERE NOW

· BREATHE MORE, THINK LESS

· AVOID ANG

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

R-FANTASIES & ANGER-REPLAYS

· THEY’RE NOT THE ENEMY …YOU’RE SAFE

· ARE YOU BREATHING & THINKING OF NEUTRAL &/or POSITIVE THINGS?

· ARE YOU JUDGING OTHERS, CYNICIZING, WORRYING? …THEN NEVER MIND

· VISUALIZE WHATEVER IT IS THAT YOU DESIRE AS ALREADY EXISTING THE WAY YOU WANT IT TO BE IN YOUR LIFE, AND DO NOT DEMAND AN OUTCOME

· INSTEAD OF REFLECTING ON WHAT YOU DON’T LIKE, VISUALIZE WHAT YOU WANT

· ASK FOR GUIDANCE >>> TRUST >>> DETACH FROM OUTCOME >>> DON’T TAKE ANYTHING PERSONALLY >>> NEVER GIVE UP

· I MAY NOT UNDERSTAND IT …I MAY NOT AGREE WITH IT …AND I

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

Combination pro

MAY NOT LIKE IT, BUT I DON’T HAVE TO TORTURE MYSELF WITH THOUGHTS ABOUT IT

· DO YOU HAVE A DIFFICULT SITUATION? …WHAT’S THE LESSON?

· BE THE TASK RATHER THAN A PERSON PERFORMING A TASK …THIS IS FLOW

· IT’S A NEW DAY – YOU DON’T HAVE TO BE HELD HOSTAGE BY YOUR PAST

· GIVE AWAY LOVE EACH DAY -- ALL DAY

· MEDITATE

· DON’T TAKE THIS (goal, task, etc.) SO SERIOUSLY …DON’T WANT IT SO MUCH …DETACH …HAVE FUN …AND EVERYTHING WILL WORK OUT EXACTLY AS IT SHOULD

· WHEN YOU HAVE A NEGATIVE, SELF-DEFEATING THOUGHT, THE BRAIN NEURONS ACCEPT SUCH PROGRAMMING AS INSTRUCT

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

ION – AN ORDER TO BE OBEYED. THUS, SUCH A MESSAGE BECOMES A SELF-FULFILLING PROPHECY. WORRY, TOO, IS PROGRAMMING …RE-PROGRAMMING IS NEEDED!

· DESIRE, BELIEF, AND EXPECTATION ARE THE COMPONENTS OF FAITH – THE LINK BETWEEN MIND AND BRAIN THAT ENABLES PROGRAMS TO BE REALIZED

· ALL HEALTH PROBLEMS ARE TRIGGERED TO A LARGE DEGREE BY STRESS – AND ALMOST ALL STRESS IS RELATED TO THE QUALITY (OR LACK THEREOF) OF ONE’S HUMAN RELATIONSHIPS …THUS, FORGIVENESS IS KEY

· PAIN, CHRONIC OR ACUTE, IS NOT MY HERITAGE, NOR IS DISEASE OF ANY KIND. PERFECT HEALTH IS MY HERITAG

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

…I CLAIM IT!

· PAINFUL THOUGHTS, EMOTIONS, OR BODY PARTS ARE SIGNALS THAT IT’S TIME TO PAUSE, CHECK POSTURE, APPLY PRESSURE POINTS, BREATHE, STRETCH, RELAX & MEDITATE

· I CAN FIGHT DISEASE BY CONTROLLING MY MOODS …AS I THINK CREATIVELY RATHER THAN DESTRUCTIVELY, POSITIVELY RATHER THAN NEGATIVELY, I AM THE FIRST TO BENEFIT BY LIVING HEALTHIER AND LONGER. ON THE OTHER HAND, IF I THINK DESTRUCTIVELY / NEGATIVELY, I AM THE FIRST TO SUFFER -- I DESTROY MYSELF. THE “PUNISHMENT” (ILLNESS) WILL ALWAYS FIT THE “CRIME” (NEGATIVE THOUGHTS).

· LET NO ONE OR NO THING

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

STEAL YOUR JOY

· LIFE HAS GENERALLY BEEN GOOD IN SPITE OF MY OPINION ABOUT IT

· I AM A WORK IN PROGRESS

· MY PEACE, JOY, RELAXED ATTITUDE & LOVE FOLLOW ME REGARDLESS OF MY EXTERNAL CIRCUMSTANCES

· THE MORE I RELAX, VISUALIZE AND IMAGINE, THE MORE I HEAL

· ENJOY EVERY MOMENT OF EVERY DAY

· THANKFUL HEART + SENSE OF HUMOR + RELAXED/JOYFUL ATTITUDE = HEALTH, HAPPINESS, PROSPERITY & PEACE

· PATH TO WELLNESS: HARMONIOUS MUSIC, HUMOR & LAUGHTER, FUN, MEDITATION, ART, IMAGINATION, LOVE, VISUALIZATION

· EVERY MOMENT IS AN OPPORTUNITY TO PRACTICE: DEEP, SLOW, RE

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

AXED BREATHING; STRENGTHENING MY WEAK AREAS; A “BE-HERE-NOW” & MEDITATIVE STATE-OF-MIND

· WHEN STRESSING OUT: MONITOR POSTURE, BREATH, RELAX, STRETCH, BE-HERE-NOW, DRINK WATER

· METHOD FOR HEALING PAINFUL JOINTS 0R MUSCLES: LIGHT EXERCISES, STRETCHES, HEAL THE PROBLEM AREA DURING MEDITATIONS, MONITOR TENSION IN THE PROBLEM AREA THROUGHOUT THE DAY, MAINTAIN A RELAXED & JOYFUL ATTITUDE

· “POOR ME” / “BAD YOU” THINKING = JOINT / MUSCLE PAIN

· MY MAIN STRESSORS: WORRY & IRRITATION

· MY MAIN STRESS-RELIEVERS: BE HERE NOW & KEEP IT SIMPLE

· I HAVE AN OVERLY DEVE

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

OPED GUILT MUSCLE (guilt is a form of worry, and worry = taking too much responsibility for things)

· BODY BUILDING IS A FOUNTAIN OF YOUTH – AND IT HELPS YOU TO BE HIGHLY PROGRESSIVE IN OTHER AREAS OF YOUR LIFE

· DO I ENJOY WHAT I’M DOING – DO I HAVE PASSION ABOUT IT? IF NOT, I NEED A NEW PLAN

· SERVING OTHERS = YOUR SPIRITUAL PATH

· THE OPPOSITE OF ‘ANGER’ IS ‘PATIENCE’

· PART OF GETTING WHAT YOU WANT IS KNOWING WHAT YOU HAVE TO GIVE UP TO GET IT

· FORGETTING YOURSELF (i.e., not monitoring self) = JOY

· INTROSPECTION & SELF-CENTEREDNESS = DEPRESSION

==>

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

Following aspects would a

Resist your impulse to strive and struggle for what you want …don’t strain to achieve. Instead, enjoy the process of the work you are doing. The results will come independent of your striving for them. Prosperity is about process, not outcome …process is about purpose …and purpose is about loving and giving.

==> When you feel you have not done enough, or that you have done the wrong thing, or that you have not tried hard enough, you feel guilty. If you continue to feel this way, you can be causing damage to your immune system. In the long or short run, th

dd to the challenges in developing combination products:

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

t damage will do you in. But positive feelings about yourself and the work you are doing, leading you to be optimistic rather than pessimistic, contribute to health.

==> Chronic emotional pain is a habit. Why suffer? Get rid of the expectation and belief that you must have it. Break the habit!

==> Negative thinking (which weakens the immune system, thus creating health problems) is: guilt --- worry --- anxiety --- secret-frustrations --- insecurity --- fear --- jealousy --- suspicion --- hatred --- antagonism --- anger --- despair --- mourning --- self-dou

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

bt --- being out of step with people and things around you

==> Positive thinking (which contributes to health) is: love --- faith --- fun --- appreciation --- optimism --- security --- courage --- cooperation --- compassion --- joy --- generosity --- friendliness --- patience --- helpfulness --- ambition --- being in harmony with people and things around you

· WHAT GOES AROUND COMES AROUND

· THE MORE YOU GIVE, THE MORE YOU RECEIVE

· EVERYTHING HAPPENS FOR A GOOD REASON

· WHAT YOU ARE FOR STRENGTHENS YOU, WHAT YOU ARE AGAINST WEAKENS YOU

· WHAT YOU CONTINU

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

LLY THINK ABOUT GROWS (i.e., expands to feelings, behaviors, outcomes, etc.)

For example: If you continually focus on how people can’t be trusted, you will find more dishonest people showing up in your life; if you continually focus on your strengths rather than weaknesses, you will find more achievements showing up in your life.

· YOUR MOST DIFFICULT PEOPLE ARE YOUR GREATEST TEACHERS

· YOUR MOST DIFFICULT SITUATIONS STRENGTHEN YOU

· YOU NEVER GET ENOUGH OF WHAT YOU DON’T WANT

· WHATEVER YOU THINK YOU CAN OR CAN’T DO -- YOUR RIGHT

· PAIN IS WEAKNESS LEAVIN

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

THE BODY

· EVERY STATE OF MIND PRODUCES A GREATER OR LESSER STATE OF IMMUNITY

· A PEACEFUL, RELAXED STATE OF MIND IS A PREREQUISITE TO LONGEVITY

· WHEN YOU TURN AGAINST OTHERS, YOUR BODY TURNS AGAINST ITSELF

· THE LESS YOU TRY TO CONTROL OTHERS, THE MORE CONTROL YOU GET

· THE MORE THANKFUL YOU ARE FOR WHAT YOU HAVE, THE MORE YOU GET

· EVERYTHING THAT HAPPENS IS POSITIVE

I’m not saying such events won’t be painful. But I know that they can teach us lessons and give us gifts that we would never have found at more comfortable times.

· I can’t be about hat

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

Professional from academic institutions, pharmaceutical industries, health care indust

e …anymore!

· When my heart is pounding ...pounding ...pounding …I have to breathe, focus on the here & now, pray and put the problem in God’s hands, and repeat the affirmation that “I have a loving/caring heart & I behave in loving caring ways.”

· In my activities: diversify and prioritize

· RATHER THAN FOCUSING ON WHAT I DON’T WANT AND WHAT IS GOING WRONG, I’LL FOCUS ON WHAT I DO WANT AND WHAT IS GOING RIGHT

· RATHER THAN FOCUSING ON HOW I AM BEING MISTREATED, I’LL FOCUS ON HOW I CAN BE A SERVANT

· I tend to take life too seriously …I tend to take things

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

too personally …I’m taking on too much responsibility …I need to SLOW DOWN and RELAX

· Rather than feeling sorry for myself …I choose to serve people

==> Traits of mine that are diminishing—

· Apprehensive

· Self-reproaching

· Worrying

· Shy

· Timid

· Threat-sensitive

· Tense

· Frustrated

· Driven

· Overwrought

· Reserved

· Detached

· Critical

· Aloof

· Suspicious

· Competitive

· Gloomy

· Pessimistic

==> Traits of mine that are increasing—

· High ego-strength

· Mature

· Faces reality

· Calm

· Self-assured

· Placid

· Serene

· Spontane

.

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

ous

· Socially bold

· Relaxed

· Tranquil

· Un-frustrated

· Composed

· Warm

· Outgoing

· Participating

· Cooperative

· Cheerful

· Enthusiastic

Speak it into existence. This is a foreign concept to many. What do I mean by speaking it into existence? Remember: What You Think About Expands. And your words are simply expressions of your thoughts. Thus, identify what it is that you want and need, and say it out loud to yourself. Here are some examples:

"Today, I have peace in my mind and joy in my heart."

"I walk through my day knowing that I have the st

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

Companies that provide selfless information through particip

ength and confidence to influence my children to make better choices."

"I am in charge of my day -- and I see myself as a victor, not a victim."

"I have a new sense of hope as well as patience."

Now -- I AM going to speak something into existence FOR YOU:

You are learning that you tend to take life too seriously.

You are discovering that you tend to take things too personally.

You are finding that you have been taking on too much responsibility.

Right here, right now -- you are slowing down and learning how to have a more relaxed attitude -- in all things

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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