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Since time immemorial, sages, masters, and mystics have been descending on the planet earth to take humanity towards hi

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

gher consciousness. They dispel the darkness of ignorance and make it all luminous with their wisdom, love and compassi

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

Examples of combination products may in

n. They take birth, they become an embodiment of the ultimate experience that can happen to any human being, and do the

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

great work of transforming lives in their own unique ways.

One of such great mystic who graced the mankind is the reve

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

ed Gautama Buddha, who renounced the comforts and luxuries of world to discover his true eternal nature. He went into d

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

Combination pro

ep meditation, attained nirvana, and then illuminated all around with his splendid and gracious presence. Buddha-the en

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

lightened one is not the name of a person but the state of being. And every individual has the potential to be a Buddha

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

rather every human being is a Buddha, the only difference is that Gautama became awakened Buddha and we are asleep.

G

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

utama compassionately shared his experiences and gave mankind numerous ways which are widely known as Buddhist meditati

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

n techniques. The most basic yet deep meditation involves the mindfulness meditation technique which requires being tot

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

lly aware of oneself and one’s surroundings. This mindfulness meditation is also referred in the eightfold path.

Anoth

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

Following aspects would a

er one is the breathing meditation technique which is very simple in nature and practice. It is all about breathing nat

dd to the challenges in developing combination products:

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

rally with full consciousness. In the beginning one is often asked to be aware of inhalation and exhalation and then co

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

nt to ten. If in between you just get involved with the thoughts and you loose track, then you start the count again. B

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

eathing has to be slow and deep. With the regular practice of this breathing meditation, by and by the seeker triumphs

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

he vicious circle of thoughts and is victorious. But this journey of persistent practice of ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

.com" target="_blank">spiritual meditation techniques needs blazing fire within to realize oneself.

That was the t

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

me of Buddha when he guided his disciples, and today we have guided meditation techniques available in the form of a cd

.

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

These guided meditation cds are no substitute to the guidance of an enlightened master. Nothing compares to the splend

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

Companies that provide selfless information through particip

r and effulgence of the master’s presence that enters one’s being and brings the real transformation beyond imagination

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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