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Ever since Internet became a widely available tool, people always imagined and used it as a virtual universe for chatting, buying and selling or simply socializing. Whe

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

ther we like it or not, the Internet has become a secondary, virtual life, for many and on this premise the concept of the metaverse was born. The metaverse is a virtua

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

Examples of combination products may in

universe that copies, more or less, the real life Universe and one of the clearest ways to express a metaverse is through what is known today as a MMO (Massively Multi

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

layer Online) game. Some of these MMO’s create a fantasy world of their own (take for example World of Warcraft, Lord of the Rings Online or Everquest) whereas some sim

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

ly offer a real-world alternative universe, as is the case of Second Life, one of the most popular such phenomenons on the Internet.

Second Life – Basic Premis

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

Combination pro

s

The Second Life metaverse is based on an Earth-like world, known as the Grid. This grid consists of land masses and “free” areas and the world is d

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

vided into 256x256 areas of “grid” called Regions. Each of these regions, powered by their own servers, has its own name and a content rating (either Mature or PG), som

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

being more stable than others. The land masses in Second Life are controlled by Linden Research (called Linden Labs in the “game”) and each of the program’s users are

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

alled Residents.

Residents of Second Life have an avatar that can be of either sex, wear different clothing, or have different physical attributes, simulating the “rea

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

life” universe entirely. Residents can communicate in this environment by several means, including local chat, which is further divided into normal chat (which can be

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

heard” in a 25m area), yelling (heard in a 96m area) and whispering (18m area) but Second Life also offers a form of instant messaging for private conversations, regard

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

Following aspects would a

less of the chatting residents’ position in the Grid.

Residents can also buy, sell and manage property and items in Second Life for a currency called the “Linden Dolla

dd to the challenges in developing combination products:

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

s” (or simply L$). There’s a virtual exchange rate in this metaverse, that fluctuates slightly, but a stable rate seems to be revolving around the 270 Linden Dollars to

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

one US Dollar ratio. You’re probably anticipating what I’m going to say next: you can actually make real life US Dollars, using Second Life Linden Dollars. Either by se

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

ling land or items, you can cash in some nice income, given the fact that you put some dedication into your Second Life avatar and you can read the virtual economy of i

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

s world.

Second Life – Conclusion

So should Second Life be considered a game? Should it be put in the same category as other Massively Multi

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

Professional from academic institutions, pharmaceutical industries, health care indust

layer Online worlds as the ones created by World of Warcraft and the likes? In principle, Second Life doesn’t share the same premises that these fantasy worlds offer, f

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

r example it has no real objectives, no “levels” and no abilities, which makes many object to the fact that it’s a “game” per say. Still, Second Life has the purpose of

.

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

entertaining its Residents through its simulation of real life, so it’s yet unclear whether we should watch it as a game or not. What is clear is that this is becoming

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

Companies that provide selfless information through particip

quickly increasing phenomenon that appeals to all genders, all ages and all religions, bringing us closer together in a virtual metaverse than we are in our real lives

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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