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Hello again

Today we want to talk about where you can find affordable resources. Important things you need are information and software, and a few other bits and pieces to build your business (you also need products, but this will be covered in a separate article).

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

Where do you find these at prices you can afford?

Finding affordable resources
Other than networking, the best source of resources is the Internet. If you are not already good at it, you need to practise surfing the net. Most people start wit

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

Examples of combination products may in

h Google (www.google.com for worldwide or US searches and www.google.co.uk for United Kingdom searches).

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

le.com/">www.dogpile.com or www.dogpile.co.uk - because they cover about 14 search engines including Google and Yahoo.

Dogpile, I believe, has a flexibility that makes your search efforts more effective. It’

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

s a little complicated, but I think it works well:

If your search term is a single word, enter it in the search bar, for example, autoresponder
If your search term is a phrase enter it using double quotes: “autoresponder software”
If your search

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

Combination pro

term involves more than one phrase, use double quotes and + signs before each phrase: +”autoresponder software”+”free download” (with no spaces except between words)

The double quotes ensure only pages displaying the phrase are listed, not pages displaying t

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

he individual words. Similarly, the + sign ensures only pages displaying both phrases are listed, not pages displaying the individual phrases.

Another good source of information on the Internet is through links. When you do a search and land on a page that interest

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

s you, you usually find a number of links that lead you to other pages and other websites.

Sometimes this takes a bit of time because the link you click leads you to a page that may have links that interest you, and this leads you to more pages. You can spend an en

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

tire afternoon and never return to your original page.

Here’s a bit of good advice: When you land on a page that interests you, write down the URL – now! It’s very frustrating to leave a page filled with useful information, never to find it again (this has happened

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

to all of us).

Another good source of information is your mentor. You must be careful not to abuse this. Although I indicated in the last article that your mentor is anxious to hear from you because you are on his or her list, there are limits. When you network wi

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

h the best, you are dealing with very, very busy people, so choose your questions carefully. Don’t bother your mentor with trivial matters.

Software
You need all sorts of software to manage your business. We have talked about some of these nee

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

Following aspects would a

ds in other articles, and we shall talk more in the future. There are three sources of software. You can:

Create it yourself
Commission it - pay somebody to create it for you
Buy it ready-made

If you are already experienced at cr

dd to the challenges in developing combination products:

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

eating software, you may ignore the rest of this article. You know far more about the subject than I, and no advice I can give you would be useful.

You can commission a piece of software – you can pay somebody to create it for you. We shall discuss this in detail i

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

n Article Thirteen.

You can buy it ready-made. Here, too, you have several options:

You can pay top money for top-shelf, all singing, all dancing software packages
You can pay less money for not-so-good-but-nevertheless-still-useful software packages
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
li>
You can download free trial editions from the entire range of software you can use for a short time
You can download free versions of some software you can use indefinitely

Software prices can be all over the place. For example, you can pay ?75

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

for a webpage building package, you can pay ?20 and everywhere in between. The ?750 package will offer you more flexibility – more features that will allow you to create pages that look exactly like you want them to look.

However, sometimes the higher priced, more

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

Professional from academic institutions, pharmaceutical industries, health care indust

flexible, more powerful package is also less user-friendly: you need to have a bit more experience to be comfortable with it. Before you buy any package check it out with your techie. If the ?20 package will do the job for you, don’t spend any more.

Quite often yo

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

u can download a free trial version of a software package, and this is true throughout the range of prices. Your evaluation period is typically 30 days. At the end of this time, you must pay for it if you want to keep using it.

There are also free versions of some

.

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

software you can download and use forever. Typically the free version only has a minimum of the features of the one you buy (looks like a front-end product, doesn’t it?). Again, if the free version will do the job for you, use it.

That’s all for this time. See you

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

Companies that provide selfless information through particip

soon.

Next time we shall talk about commissioning software. This is when you pay somebody to create a piece of software that is entirely yours.

Thanks for listening :-)

Copyright © 2006 Mary Rice-Johnston & Golden Goose Direct. All rights reserved

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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