Advice You - Internet and Businesses Online

There are two sources of Internet problems in Turkey -- those of big city origin and those of small city origin. Becau

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

se we live remotely down here on the beach in small-city G?m?ld?r, both types can strike us without warning.

This pas

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

Examples of combination products may in

Friday afternoon, for instance, we got hit by the big city problem-variety -- when our primary email provider, EgeNet

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

(out of Ege University, the largest university in Izmir, the third largest city in Turkey, with a population of around

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

5 million), suddenly went into a black hole (for the second time in two months), from which it still hasn't emerged al

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

Combination pro

most 3 days later.

We presume that it will rise from the ashes again (just like the last time) sometime around mid-af

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

ernoon today, now that the no-work weekend is over. But we're not sure -- because the telephone call we made and the 2

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

email queries we sent have each disappeared into that same aforementioned black hole.

Which is why, besides EgeNet, w

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

have 3 backup email providers... Currently, they are TTNET Mail (run by T?rk Telecom) in-country and Google's GMail a

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

nd Yahoo's YahooMail out-country.

That may sound like overkill to you, but once (about 5 years ago) when Turkey's Int

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

rnet access to the outside world 'went south' (due to a severed underwater communication cable off the coast of Greece

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

Following aspects would a

, our triple failsafe email backup operators (of that time) took up the slack that EgeNet couldn't handle and helped u

dd to the challenges in developing combination products:

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

through a very dodgy 6 week period. And when another underwater cable was severed less than a year later, we hardly n

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

oticed a ripple -- because, by then, we were practiced hands at that particular sort of ' Internet workaround'.

In fa

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

t, we even surprise ourselves sometimes --- at our ability nowadays to work around most of the operational problems th

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 can affect our 'Internet life' ... from electrical brown and blackouts, downed telephone lines, telecomm service bre

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

Professional from academic institutions, pharmaceutical industries, health care indust

kdowns, equipment failures, international internet connection cutoffs, and so on. But, we've been through a lot since

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

we arrived in 1992 -- and if we hadn't learned to cope by now, it'd be even more surprising. Now, wouldn't it?

[Cl

.

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

ck following to access a fully illustrated HTML version of elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

survival-kit--006-06-05-2.html" target="_blank">Internet Survival Kit for Turkey.]

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 You - An Internet Survival Kit for Turkey -- Watch Your E-Mail's Back!

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