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The power of our thoughts cannot be underestimated. If we did not think we would not be human. The famous philosopher, Descartes, decided that the only way he could really know that he was alive

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

was through his thoughts. He worked out that his senses such as sight and hearing could play tricks on him as evidenced through optical illusions or thinking we hear something when nothing is the

; 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. The only thing he knew for absolute certainty was that every minute of every day he was thinking. Even in our sleep are brains are active indicating thought processes are in action. When we a

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

e alive we are thinking.

The word 'paradigm' means a pattern or a model. Our thoughts are arranged in paradigms in our head. What this means is that our thoughts follow a certain model that we h

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

ve created for ourselves. Very simply put an angry man lives in an angry world. His thoughts follow a model of anger. It almost seems that everything he sees or hears somehow turns into anger. Do

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

Combination pro

you know anyone like this? Likewise a happy person lives in a happy world. The angry and happy people could be standing side by side looking out at the same world but ultimately see things totall

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

differently.

So where have these models of thinking or paradigms been set up? The answer is they were programmed and set up from early childhood. Who ever our primary caregivers were gave us th

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

e blue print for the paradigm that would become our thought patterns. As a therapist I see this over and over again. Anxious people ultimately have one or more caregivers (parents etc) who were a

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

xious. Angry people had a background of anger when growing up. There is a close correlation between our upbringing and the way we think as adults.

It can be argued that depression is a learnt wa

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

of thinking and being. If we came from an abused background, full of low self esteem reinforced by caregivers who constantly told us how useless and worthless we were, depressive thinking can be

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

ome the norm. There are many scenarios that can lead to depressive thinking. Perfectionist thinking grilled into us from our parents can lead to depression.

This brings us to a main point in thi

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

Following aspects would a

paper and that is the concept of being ‘comfortable’ with our thinking including depressive thinking. Why would this be? It is simply because we have never had another alternative to the way we

dd to the challenges in developing combination products:

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

ave been taught to think. If we did experience any of the above listed ways of thinking when we were children, there was unlikely another way of thinking operating side by side with us that offer

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

d a more positive alternative. Our family life as children tends to be our whole world despite any alternative ways of thinking that may be presented around us (such as from friends at school).

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

Often it is only when ‘dis-ease’ such as depression or relationship breakdown later in life surfaces, that we seek help to find solutions to the problems. “Why am I thinking this way? Why has my

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

elationship died”, we may ask? The answer can often be found in our thinking, which may be that “I am used to be treated less than favorably; I am used to having low self-esteem; I am used to fee

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing low and not worthy – it would be normal and comfortable for me to keep this going despite how unhappy I feel”. Really, that is it in a nutshell. The real difficulty for me as a helper, a ther

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

pist is to shift this thinking, to get sufferers out of their ‘comfort’ zone and start to explore more positive ways of thinking and being. It can be quite awkward to move into this new arena, th

.

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

s new way of thinking and being, especially after years of being and experiencing the other negative way of being. But it is possible and if successful can open incredible ways of being that were

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

Companies that provide selfless information through particip

once only dreamed of. It is possible to have and truly experience health, wealth and happiness. If you don’t believe so, it could be time to check in for a new dose of how to change your thinking

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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Unsecured debt consolidation loan provides you an opportunity for lessening debt burden at low cost and gives ample time to recover financial health. The loan is availed in hassle free manner as it is designed considering fragile financial position of the borrowers. The article discusses ways to take the loan beneficially.

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