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1. Do you feel like not wanting to respond to emails from new lead sometimes?

2. D

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

o you sometimes reckons that despite your best effort to explain,, the new leads do

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

Examples of combination products may in

not really read your reply?

3. Do you feel that people are just lazy to read whate

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

er you have provided in FAQ?

Well, when I felt this way, I always remembers the st

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

ry about the person who throws starfish back to sea everyday from the beach. One se

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

Combination pro

tence stuck with me, he said, "... at least I made a difference to this one..."

Th

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

t it is! It does not matter, whether all of them get it or not, as long as one of t

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

hem, just one of them gets it, your effort is well worth it.You have made a differe

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

ce to one person, and your business has just grown.

Recently, I received a copy of

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

an email

Quote

I responded on April 24, 2007 just for curiosity
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
, and it was a surprise to me that I received an e
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
ail the next day. I replied with my doubt and then
dd to the challenges in developing combination products:

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

u>I got his answer back.

Unquote

You se

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

, the person on the other end of the email do expect some responces from you.We may

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

be operating a High Tech business but to do business, we still need High Touch! Ev

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

n though that person on the other end may be half a world away, with High Tech, we

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

Professional from academic institutions, pharmaceutical industries, health care indust

re able to keep High Touch by using technology, for example, instant messaging, ema

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

ls and even web cam!

Please remember, respond as fast as you can, YOU might just m

.

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

de a difference to another person!

Yeo Tien Kiong

Serious Part Time Online Entrep

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

Companies that provide selfless information through particip

eneur

www.yeotienkiong.ws

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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