Just Answers - Computers and Technology

Every so often your computer is going to stuff up on you for one reason or another - if it doesn't then you are either not using your computer much or you are really lucky. It probably wont be a computer vi

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

rus, it is more likely to be due to your accidentally pressing the wrong key or clicking on the wrong thing and not noticing your mistake until after things have started to malfunction. Most likely you wont

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

Examples of combination products may in

even remember the mistake that you made that causes the problem. The first thing you will probably try to do is to fix the problem.

Most times when things go wrong and you try to fix them you succeed and

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

the problem is resolved. Sometimes things just get worse. Some time ago a friend asked me to help with solving a problem with their computer where they had lost their internet access. I took a look at what

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 coming up on their computer a4nd made a note of the error messages that appeared. I later typed some of the keywords from these error messages in to the Google search engine and found pages on the inter

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

Combination pro

net that described the problem and how to fix it. I applied the appropriate fix to the friend's computer and those particular error messages disappeared to be replaced by a new set of error messages at a di

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

fferent spot in the connection process. The obvious fix didn't fix the problem.

I tried looking up the new error messages but was unable to find anything useful to try next. It was at this point that I fou

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

nd out that the friend had tried to fix the problem themselves first and the fix that they had applied had caused the problem that I had solved. All I had managed to do was to remove the second problem from

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

their system without identifying the cause of the original problem. I also couldn't tell whether anything else on the computer had changed as a result of earlier attempts to fix the problem. There were an

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

unknown number of changes that had been made to the system since the original problem had occurred making analysing the problem much more difficult.

In the end the friend gave up waiting for me to find the

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

solution and paid someone else to fix it for them. They also were unable to determine the cause of the problem with the computer in situ and had to take the computer back to their office for further analys

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

Following aspects would a

is where they had other computers available to assist. It was only then that they discovered that the modem driver had been deleted from the system and that was why the modem would not connect to the intern

dd to the challenges in developing combination products:

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

et. There certainly wasn't anything in any of the error messages that came up to even give the slightest hint that a missing driver was the cause of the problem. Maybe if I had looked at the computer straig

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

ht away before any other changes had been made the possibility may have occurred to me.

That wasn't the end of the problem because the original driver disk had gone missing so reinstalling the driver was n

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

ot as straightforward as it could have been. I don't know where the company that fixed the computer got the replacement driver from but the most useful place to go to find drivers for any computer system 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

DriverGuide.com and that is where I would have gone to find the missing driver had I realised what the problem actually was.

If at some future time you find your computer has a problem, don't rush into ap

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

Professional from academic institutions, pharmaceutical industries, health care indust

plying the most obvious fix. The problem may not be what you initially think it is and the "fix" may just make it more difficult to uncover the real problem. You need to clearly identify the true problem be

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

fore most fixes can hope to work and applying changes that don't fix the problem can just make it harder to determine what the problem really is.

Of course, if I get stuck with my own computer system I can

.

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

always find the backup tape and with a couple of hours work, restore my system back to a stage where I know that it will work (assuming that the problem isn't hardware) and if my friend had a backup of the

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

Companies that provide selfless information through particip

ir system then restoring would have fixed their problem straight away. Unfortunately most people don't backup their computer so this sledgehammer solution isn't even available to them. Do you backup your's?

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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Every organization - big or small - has a unique culture. The culture is defined by every member of the organization - not the executives alone. And every team member has the opportunity - really the responsibility - to challenge the organization's culture if it isn't as successful as it could be.

To understand the search engine and to use it effectively, you must first understand how it works. First, the search engine is understood as an IR scheme, or retrieval system that allows researchers, as well as web developers to use the IR to discover millions of topics worldwide.

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