Advice Pool - Relationships

Relationships connect us in this world with each other. We have many kinds of relationships- parental, sibling,

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

friends, professional and love. We go through many phases in all these relationships. Ups and downs are part o

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

Examples of combination products may in

f our life and our relationships. Most of us can bear break down in most of the above relationships except thos

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

e of love. Why? Who will survive a breakdown in romantic relationship and who will get shattered? Let us discus

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

s.

The higher the attraction, the higher will be the shock. The closer you are, the break up will give you mor

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

Combination pro

e shock. It is very simple equation. But let us remember that life is not made of equations and emotions do not

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

behave mathematically. So it all boils down to personality. There are some who expect the relationship to brea

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

k sooner or later. They are pessimists and call themselves practical. These people are never surprised if the r

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

elationship breaks. They may wonder about the reasons but will not suffer trauma.

On the other extreme, we hav

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

e some people who believe that they are made for each other and that the relationship, the loyalty and the fait

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

fulness will last for the life and if possible beyond. This is the vulnerable class. If by bad fate, they are d

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

Following aspects would a

itched by the partner, they will suffer very bad trauma. They will never believe that this could ever happen an

dd to the challenges in developing combination products:

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

d all their life they will spend wondering how it happened. Their faith in their partner is absolute. They trus

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

t their partners most and for them the shock of the broken trust is unbearable. They need psychiatric help. Hop

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

efully with professional help they may recover. But at times the trauma is uncontrollable. They lose their fait

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

h in life and everyone else. The betrayal kills their inner core and the will to carry on. If you are one such

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

Professional from academic institutions, pharmaceutical industries, health care indust

type, please go into any relationship with the awareness that your partner may not be as honest as he/she looks

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

.

Relationship is a beautiful feeling and a wonderful experience. One tends the relationship as one cares for

.

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

a tender plant. One gives ones whole being to the relationship. The breakdown therefore becomes unbearable. Som

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

Companies that provide selfless information through particip

etime I feel that the world is for people who are practical and never allow their heart to rule over their mind

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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Advice Pool - Will You Survive a Relationship Breakdown?

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