Suggest - Relationships

It must be my love and passion (and lots of 'sensitivity') for 'relationship'. 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

always enjoy seeing how people deal with 'relationship' - any kind of relation

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

Examples of combination products may in

ship.

Very often I will learn some lessons and wisdom from them.

Just last mon

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

h I was at my niece's church wedding.

As usual, I became uneasy when the pastor

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

was giving his 'speech'. I just didn't want to hear any message on why we shoul

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

Combination pro

not be taking the other half for granted.

I have heard too many times on this.

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

But his message hit me hard this time.

The pastor didn't use that 'for granted

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

' statement throughout his speech. Instead...

"Don't be careless!" was the one.

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

Yes. Yes. Yes.

I was careless towards my wife's feeling just...

- when we were

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

leaving for the church,

- when I was driving,

- when I was parking my car,

-

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

hen we were crossing the road,

- when my youngest daughter making so much reque

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

Following aspects would a

sts,

- when... oh no, I am too ashamed to go on.

Were you careless?

There was

dd to the challenges in developing combination products:

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

once my wife and I were finishing a drama series on TV. This is something we enj

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

y doing together.

The husband in the story was dying of brain tumor. He could

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

not see.

He could not hear. Well, you know, this is too common in drama. But wh

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

t he said to his wife 'woke me up' (Did it wake my wife up? I was not sure)...

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

Professional from academic institutions, pharmaceutical industries, health care indust

"Darling, I thought it was enough just to listen to your voice when you were ta

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

lking. Now I really miss looking at you. I was so careless.

I should be looking

.

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

at you more often."

Were you careless?

I was.

Are you careless?

I am.

But I

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

Companies that provide selfless information through particip

am going to be more careful from now on.

Teecee Go
www.AboutRelationship.co

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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