Your Space - Self Improvement

Self actualization: that time to relate to our inner world and operationalize those late

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 gifts and talents. We express our uniqueness in any variety of ways: writing, working

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

Examples of combination products may in

or helping others, painting, community projects, new careers or business ventures.

It i

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

s entirely appropriate to look at retirement as a time for self-actualization. If we acc

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

pt that we were created to make a unique contribution, then self actualization is making

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

Combination pro

that contribution.

Abraham Maslow, a psychologist, described self actualization as a ne

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

ed that begs to be fulfilled when we meet the more basic physical, safety, love and acce

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

tance needs. Maslow felt that we grow our entire lives and that we each have something

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

nique to express. When we reach retirement age, we usually have our more basic needs me

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

t; now we are in position, in fact, encouraged by our inner direction to be self-express

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

ve.

Usually, we have had habitual masters that we have served: our job, schedule and co

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

Following aspects would a

mitments. In retirement those external voices are no longer there, and we have the oppor

dd to the challenges in developing combination products:

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

tunity to express our inner desires. Ask yourself, what do I want to express? The answer

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

will come, sometimes we have turned the volume so low that it will take some time to hea

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

it, but it will get louder.

We allow others to enjoy our inner being without worry of

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

acceptance, without the need to satisfy others, merely from the joy of self-expression.

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

Professional from academic institutions, pharmaceutical industries, health care indust

t is a natural progression if we allow it.

The rewards can astound us: a feeling that

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

othing is left wanting, a sense of freedom and liberation, a sense of total involvement,

.

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

of self harmony, a sense of satisfaction that we are an integral part of all that surro

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

Companies that provide selfless information through particip

nds us. We feel we are fulfilling our true individual purpose so that others can benefit

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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