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Depression is a signal that one has gotten off track - that your life is not in alignme

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

nt with your deepest needs, values, interests and gifts. What does that mean? What trac

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

Examples of combination products may in

have you gotten off of? One way to think of it is to think of people you know who have

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

obviously gotten themselves into situations that are a mismatch for them. For example,

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

n artistic person who works in a Fortune 500 company for job security would be an examp

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

Combination pro

e of a person who is off track. Sometimes people make marriage choices for all the wron

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

g reasons.

Two reasons your life may get off track is because of conformity and the ne

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

d for security:

Conformity

One of the main reasons you might make a bad choice that i

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

out of line with your own real interests and desires is to conform to the expectations

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 others. Many times, parents’ expectations set a person on a life course. Conformity

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

ay also come from friends, peers, media or other larger cultural forces.

Need for Secu

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

Following aspects would a

rity

Another reason you might ignore your own internal signals is that the need for se

dd to the challenges in developing combination products:

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

urity can overpower your own sense of what is essentially meaningful. The need for secu

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

ity can take other forms such as staying in relationships that are familiar or safe. Or

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

you may fail to take necessary risks to make your dreams come true. Sometimes depressio

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

occurs and makes you so miserable in your current lifestyle, to make it clear to you t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat the comfort of familiarity also comes with a price. Depression can serve as an indu

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

ement for taking risks. You begin to realize that though there are costs to moving away

.

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

from security, the cost of depression for not taking any risks is already a high price

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

Companies that provide selfless information through particip

o pay. Depression reminds you that you are losing your life while you are not risking

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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