Useful Advices - Business

THE GOLDEN RULE, do you believe in applying it to your cattle deals? And if not do you sleep well at night?

I

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

believe it may be the origin of or relates to the true meaning of what our forefathers had reference to when

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

Examples of combination products may in

they came up with the idea of what is referred to as a HAND SHAKE CATTLE DEAL. Have you applied it to your cat

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

tle deals? If not, I challenge you to give it a try; it has worked for many others.

The golden rule is endors

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 in most all regions of the world. And for many centuries the idea has been influential among people of very

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

Combination pro

diverse cultures. These facts suggest that the golden rule may be an important moral truth.

The golden rule i

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

s best interpreted as saying: Treat others only in ways that you are willing to be treated in the same exact s

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

ituation. To apply it, you should imagine yourself in the exact place of the other person on the receiving end

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

of the action. If you act in a given way toward another, and yet are unwilling to be treated that way in the

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

same circumstances, then you violate the rule.

To apply the golden rule adequately, we need knowledge and ima

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

ination. We need to know what effect our actions have on the lives of others. And we need to be able to imagin

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

Following aspects would a

e ourselves, vividly and accurately, in the other person's place on the receiving end of the action. With know

dd to the challenges in developing combination products:

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

ledge, imagination, and the golden rule, we can progress far in our moral thinking.

The golden rule is best s

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

een as a consistency principle. It does not replace regular moral norms. It is not an infallible guide on whic

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

h actions are right or wrong; it does not give all the answers. It only prescribes consistency that we not hav

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

our actions (toward another) be out of harmony with our desires (toward a reversed situation action). It test

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

Professional from academic institutions, pharmaceutical industries, health care indust

s our moral coherence. If we violate the golden rule, then we are violating the spirit of fairness and concern

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

that lie at the heart of morality.

The golden rule, with roots in a wide range of world cultures, is well su

.

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

ited to be a standard to which different cultures could appeal in resolving conflicts. As the world becomes mo

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

Companies that provide selfless information through particip

re and more a single interacting global community, the need for such a common standard is becoming more urgent

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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