Advice Pool - Relationships

We acquire our values from different sources. In the beginning our values are gi

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

ven to us by our parents. Speak truth, help others, do this and don't do that an

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

Examples of combination products may in

d things like that. After sometime, we get more values in our education. We read

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

about values of great people and try to live by some of them. Our religion give

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

us many values. How to live, what is right, what is wrong and what is allowed,

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

Combination pro

what is not allowed are some values that we get from the religion? Today if you

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

observe the difference between pro and anti abortion lobbies, you will find a va

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

ues conflict. In your relationship, have you found out values of your partner? H

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

ave you spelled out your values?

Values are dear to us. For some of us, values

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

are very dear. It is found that some people even give away their life to safe gu

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

rd their values. Such value contradiction can play havoc with your relationship.

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

Following aspects would a

Some of us sympathize with poor and try to help them, while others opine that p

dd to the challenges in developing combination products:

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

oor need not be helped, as it is their karma that is giving them this pain. Let

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

them suffer. This singular value difference can kill your relationship, if you b

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

th are not ready to compromise on them.

Please talk to your partner about your

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

values in the beginning of the relationship. Spell out your values very clearly

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

Professional from academic institutions, pharmaceutical industries, health care indust

and be honest that you will not compromise on any of them. Let your partner do t

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

e same. Compare the values and discuss the differences. Decide at that point abo

.

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

ut the relationship. Both of you should be aware that the difference can kill th

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

Companies that provide selfless information through particip

e relationship in future. Take any step forward only after this value comparison

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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