Advice Pool - Self Improvement

So when did your journey begin I am frequently asked. That question always makes me smile for my Journey began when yours did - at the beginning. Since the day we were born we have been on 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 wonderful journey - born as free children, honest, innocent, authentic with our emotions, creative, loving, wise little beings of light.

And then as time goes on we are taught ego ways and

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

Examples of combination products may in

how to fit in, what we should and shouldn’t say, speak when spoken to, be seen and not heard, what to wear, what we felt or said as children was lesser than those around us. Tears were for 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.

abies – to pull ourselves together and become unemotional “clones” – Need I go on?

Our pure light becomes hidden beneath so many layers that do not belong to us but to another or a religion,

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

or a school, or a government …

In our eagerness to fit in and please We soon forget that we ever forgot who we are …

Something is missing, something does not feel right as we get older and l

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

Combination pro

ive life in this “Straight Jacket” hardly breathing (well actually we forget to do that too *smile*) – the search begins for happiness, love, wholeness – but we were taught to look for it outs

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

ide – in a partner, a career, a family, and yet still we feel empty, lost, lonely, discontented –

And then it is the “how hard does it have to be before you listen”

Listen?

To who?<

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

br>

Your heart – You – that’s who – the YOU that you forgot, you forgot!!

That is when people say their “journey” began but it is not. It is when we choose to see and we choose to becom

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

e spiritually awakened, realising that we are not just mind and body but we are spirit too – and that is what has been missing – our spirit.

We see that the life of work, Sainsburys, headache

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

s, materials and un fulfilment is not the whole picture – there is more and it is achievable. We understand that feelings are what is missing from the inside not the outside.

The other quest

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

ion I get asked is “What is my purpose?”

And the answer is – your passion.

And you will find your passion, as you begin to find you – how can you know your passion, your purpose when

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

Following aspects would a

you have been living to someone else’s rules and hiding.

These two questions have one solution. That solution is to peel back the layers of beliefs – when you think or feel something – ask

dd to the challenges in developing combination products:

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

is this really me or does it belong to someone else? When you speak – are they your words – are they honest, truthful, and loving. How do you live your day - is it by your rules and expectat

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

ions or somebody else’s – whose boundaries are you living by…

And then in your silence, everyday start listening to your heart. Spend time getting to know you. Gradually you will hear a son

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

g and it will guide you to you and the gift you were born to share.

I do not know what your passion is or your purpose, only you know your truth and that it is why it is so important to trust

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

in you, your feelings, your intuition, your dreams … You can be guided there but no one can take you there but you.

You are the truth!!

I finish now with a little story that made me smi

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

Professional from academic institutions, pharmaceutical industries, health care indust

le and made me laugh. A little Hindu story of truth.
One day God got tired of people. They were always pestering him, asking for things. So he said, “I ‘m going away to hide for a whi

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

le.” So he gathered all his advisers and said, “Where should I hide? Where’s the best place for me to hide?”

Some said, “Hide on the highest mountain peak on Earth.” Others said, “No, hide

.

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

at the bottom of the sea, they’d never find you there.” Others said, “Hide on the other side of the moon: that’s the best place. How are they going to find you there?” Then God turned to his

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

Companies that provide selfless information through particip

most intelligent Angel and asked him, “Where do you advise me to hide?” The intelligent Angel smiled and said, “Go hide yourself in the human heart. That’s the only place where they never go!

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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