Suggest - Relationships

Have you heard of couples who do not talk to each other for days or weeks because one partner had not forgiven the other for something that the other did? Th

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

ey have become board-mates who live in the same house or apartment but do not speak to each other. Their actions toward each other are mechanical and lifeless

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

Examples of combination products may in

. Unless the person who is offended forgives the other, the relationship is doomed to die!

Unforgiveness affects attitude. It is the result of pride. “You

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

offended me and hurt me and therefore, I will not forgive you”. This kind of attitude is destructive. Unforgiveness past relationships is like drinking poi

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

son and expecting the other to die. You are the one affected and so will your children or family or spouse be adversely affected.

Being human, we are prone

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

Combination pro

to commit mistakes. We may say or do things that offend our partner. And most of the things we say and do that offend or hurt our partner are unintentional.

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

Who wants to destabilize a relationship on purpose? No one in his or her right mind would do that.

Unfortunately, these things happen. And they happen all

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

too often. And misunderstanding arises. Tempers flair up. A huge fight looms. And then silence. Silence that goes on for hours, days and even weeks leads

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

to unforgiveness past relationships.

The Holy Book states an episode in the gospels where Jesus was asked by one of his disciples…. “Lord, how many times sh

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

ould we forgive? Seven times?” Jesus answered by saying… “Not seven times, but seventy times seven times.”

The message is clear, if we count the number of

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

times we forgive a person, seventy times seven is equivalent to four hundred and ninety times! Who would want to count and keep track of the number of times

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

Following aspects would a

he has forgiven the other, up to almost five hundred times? We might as well stop counting. One should not unleash unforgiveness.

Again, this all boils dow

dd to the challenges in developing combination products:

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

n to attitude. Take an inventory of your attitude. Although attitude sounds like an overused word, it’s much, much more important than just being positive.

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

You need to be hopeful in your relationship; you need to have a feeling that somewhere, there is a solution to forgiveness. And I can find it. I can find that

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

solution to patch up a broken relationship.

Some things just cannot change. People will continue to make mistakes. You just have to say to yourself, it is

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

what it is. You just cannot change that.

You may have heard of the story of a father who had not seen his son, whose name was Paco, for many years because o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f something that the son did to the father who could not forgive him. The father realized after all those years that his unforgiving spirit had done nothing

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

but cause sleepless nights and misery. He decided to place an ad on the local newspaper reading “Paco, my son. I forgive you and if you find it in your hear

.

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

t to forgive me, meet me at the fountain in the town square at noon on Saturday… signed your father”.

On Saturday noontime, 800 men named Paco turned up at t

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

Companies that provide selfless information through particip

he fountain, hoping that it was their father who placed the ad forgiving them.

Have a forgiving spirit, mend relationships and enjoy life, for life is short.

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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