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Why does doubt so easily loom in our minds? Why don't we just believe that the best will occur in life? No matter a person’s age or circumstances, it seems

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

that doubt freely dances in our minds. We question our spouses, our children, our employer, our co-workers, our friends, and ourselves. We often pose questi

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

Examples of combination products may in

ns in our minds that start with “What if…”. What if she does not like me? What if my boss thinks I should perform better? What if I came across to strong?

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

Our mind starts racing and starts drawing conclusions and ideas from anywhere and everywhere. The majority of the time we have no idea if there is even valid

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

ty in our thoughts, but we keep letting them work in our minds anyway.

What exactly is doubt? Doubt is a lack of trust, to be uncertain or undecided, to wai

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

Combination pro

er in opinion or belief, and to tend to disbelieve. Does this sound true of some of your thoughts?

Doubt can draw us to question our existence, our purpose,

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

how we talk and interact with others, how we view others, and what others are thinking of us. Just to name a few. Doubt can pertain to ourselves, our family

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

our friends, our community, and our world-- basically, doubt can pertain to anything.

Quite often, certain people or circumstances and actions can trigger d

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

ubtful thinking. We can have a lack of faith in others or a lack of faith in ourselves, which feeds on or creates greater doubt. Even the actions of other p

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

ople can create doubt in our minds. For example, if our sister does not call for several days we can begin to think that she is mad or upset about something

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

hat I did or did not do. Our mind begins to create our own conclusions for our sister’s actions. However, if we just call our sister we would discover that

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

Following aspects would a

she has been really stressed at work and just has not had the time to call.

Doubt can also bring us into a state of confusion and unrest. We do not know how

dd to the challenges in developing combination products:

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

to quiet the “What ifs…” and doubtful thoughts in our mind. We lose our focus.

Now that we have defined doubt, how does one begin to conquer it? First, we

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

eed to set our mind on hope. Hope is a feeling of what is wanted will happen, a desire accompanied by expectation, or to want. Hope is not visible; instead,

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

it is a feeling, a deep knowing, and a deep longing. Hope can find its way into our family, our friends, our community, our world, and ourselves if we only l

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

t it happen. Sometimes hopeful thoughts cannot be carried out in our lifetime, like ending poverty. Nevertheless, we can still have this hope for our world.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Once hopeful thoughts begin to enter our minds, anything can happen. Our perceptions and attitudes begin to change and we start to see the world, our selves

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

our friends, and our family differently. We are no longer confused and unfocused by thoughts of “What if” or doubt, but thoughts of possibility.

Lastly, mo

.

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

ing from doubt to hope involves a change of mindset. This may mean that old habits need to be stopped or that a new habit needs to be implemented. What mind

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

Companies that provide selfless information through particip

ets do you need to change? How can you begin to harvest hope instead of doubt? Having a mind of abundant hope is intoxicating. Begin to live this way today

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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