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Computer Help Desk Stupid Questions brought to you by Computer Service Now (CSN) CSN Helps desk technicians

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

know first hand that the phrase 'there are no stupid questions' is untrue. It's understandable that peopl

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

Examples of combination products may in

e are nervous about computer technology, but everyday computer technicians are asked to help people out of

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

problems that leave them asking...
...how do you get to work?

Here is some proof from the help de

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

sk stupid questions archives at CSN:

A customer was enraged because his computer had told him he was "Bad

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

Combination pro

and an invalid." The tech explained that the computer's "bad command" and "invalid" responses shouldn't be

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

taken personally. Another customer called tech support to say her brand new computer wouldn't work. She sai

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

d she unpacked the unit, plugged it in and sat there for 20 minutes waiting for something to happen. When a

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

sked what happened when she pressed the power switch, she asked, "What power switch?"

Computer companies h

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

ave change the text to their manuals from "Press Any Key" to "Press Return Key" because of the question wh

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

re is the "Any Key"?

A confused caller was having trouble printing documents. He told the technician that

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

Following aspects would a

the computer had said it "couldn't find the printer." The user had also tried turning the computer screen t

dd to the challenges in developing combination products:

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

o face the printer-but that his computer still couldn't "see" the printer.

A woman called with a problem w

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

ith her printer. The tech asked her if she was "running it under windows." The woman responded, "No, my de

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

sk is next to the door. But that is a good point. The man sitting in the cubicle next to me is under a win

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

dow and his printer is working fine."

And last but not least:
TECH SUPPORT: "O.K. Bob, let's press t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he control and escape keys at the same time. That brings up a task list in the middle of the screen. Now ty

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

pe the letter "P" to bring up the Program Manager."

CUSTOMER: "I don't have a 'P'".
TECH SUPPORT: "On

.

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

your keyboard, Bob."
CUSTOMER: "What do you mean?"
TECH SUPPORT: " 'P' on your keyboard, Bob."

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

Companies that provide selfless information through particip

r> CUSTOMER: "I'm not going to do that!

CSN specializes in nationwide multi-location computer support

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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