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Lost, but you don't know where you're going.

Lost is a horrible place to feel. You recognise it because Life just doesn't seem to be working. Nothing is satisfying, or at least noth

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

ing is satisfying for very long. You look back and you have no idea what you did wrong. Or you may look back and see one wrong turn after another, one wrong choice after another. But

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

Examples of combination products may in

when you examine each of those choices in isolation, you know that you made the best choice you could given the circumstances that surrounded you at the time.

The worst of it is, t

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

hat if someone gave you a magic wand and three wishes, you know, deep down, that no matter what you wished for, as soon as you got over the excitement of change, that you would feel

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

ust as lost, just as dissatisfied with life.

You may not realise it but Lost is a Spiritual Problem.

By Spiritual I don't mean religious. By Spiritual I do mean that it is to do wi

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

Combination pro

th the essence of who you really are, the essence of the love that you are.

Entertain the idea for a moment or two that maybe, just maybe, Life is a Journey with a Purpose. The map

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

of that journey is coded, say, in your DNA, or maybe it's something instinctive or intuitive, but it's there and we can somehow feel it. Then during our formative years we are social

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

ised into looking outside ourselves for answers rather than within. We are taught not to trust our instincts, but to obey rules. Other people always know what is best for us. Be that

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

well-meaning parents, teachers, religious leaders, supervisors, managers, politicians. Some of the people who guide you will have your best interests at heart; some will have their o

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

wn. Either way you are taught to think for yourself, but only if the solutions you produce are acceptable. When you are intelligent, or curious, or talented, or playful, or thirsty f

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

or knowledge about something you have an interest in and you ask your teachers questions that they don't know the answers to, you may be deliberately discouraged from asking 'stupid'

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

Following aspects would a

questions.

If questions are asked with a genuine thirst for knowledge, then there are no stupid questions.

It is because we are discouraged from listening within that we lose sigh

dd to the challenges in developing combination products:

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

of what we are here to accomplish. And when we wander way off the map within - then we are lost. Then nothing seems to work. Then life seems unsatisfying. Then we feel unfulfilled.

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

The way to get back on the map is to start to look within for answers. Not answers you get from knowledge, but answers you get from gut instinct, answers you get from whether or not

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

something just feels right.

If you want to start the process right now, then look through your memories for something you used to enjoy and brought you pleasure. Something you have

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

n't done for a long time. Then go out and do it. Make a pact with yourself to do something you really enjoy for a little while each day. Something as simple as watching something on

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

Professional from academic institutions, pharmaceutical industries, health care indust

v that makes you laugh, feeding the ducks on the local pond, building a sandcastle even though other people are watching. It doesn't have to be complicated or earth-shattering. Simpl

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

e pleasure. That's all.

What this does is communicate a very important message to the forgotten part of you. It says, 'I'm ready to come home, so please turn on a light to guide me'

.

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

and you'll find that magical things start to happen. You'll find your interest in life itself returning. You may also discover that you're in the wrong relationship, the wrong job,

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

Companies that provide selfless information through particip

the wrong location, and want to make changes and that's fine as long as the changes feel right deep down inside. Use that as your guide from now on and you will soon be back on track

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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More than any other ancient society (except Rome), the Greeks kept very accurate records about their daily life. It can be understood from their literature, art (and ceramics), as well as the records of other countries that mentioned the Greeks.

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