Useful Advices - Business

ARE YOU LOL?

Dear Fred and Lyna,

I have been sending my blogs out and participating in some business forums an

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

d people are always using these abbreviations. I also see these on instant messages that I get. For example, I

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

Examples of combination products may in

et the following all the time: LOL BRB DQMOT IDK…just to name a few..Can you help me understand this new inter

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

et language.

Fred: I’m LOL(laughing out Loud) is a common term that is used all the time in emails, IM(Instant m

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

ssages) and on the forums. It is like learning a new language.

Lyna: I know when I first started see these terms

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

Combination pro

I had to ask you what the heck they meant.

Fred: The scary thing is that I now what they mean. Does that mean I

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

m spending too much time on the internet.

Lyna: You don’t want me to go there, Fred. But let’s get back to what

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

all these acronyms mean

Fred: Let’s first take a look at the ones you mentioned about. BRB means Be Right Back.

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

This is often used in IM when someone has to get away from the computer.

Lyna. DQMOT is a rather long acronym bu

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

it simple means Don’t Quote Me On This.

Fred: IDK means I Don’t Know.

Lyna: Like most acronyms all you need t

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

do is use the first letter of the word to form the acronym. For example someone may just type a Q which means

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

Following aspects would a

have a Question.

Fred: That works for most but what about L8R, which means Later

Lyna: or Noob which mean Ne

dd to the challenges in developing combination products:

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

bie.

Fred: The list goes on and on and fortunately there are acronym dictionaries on the internet that will help

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

explain what all these mean.

Lyna: Since the advent of the internet a whole new language has developed.

Fred: N

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

ot only these acronyms but other terms as well.

Lyna: So, why is this important for someone who runs there own b

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

siness.

Fred: The internet is the new media for promoting your goods and services and you have to be familiar wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

h the language other words you’ll get lost.

Lyna: Our suggestion would be to start participating in the forums a

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

d also to write at least a monthly blog.

Fred: BTDT(Been There Done That)

Lyna: LOL( Laughing Out Loud)

Fred:

.

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

It’s not that hard to learn and we would recommend that you keep a list of these acronyms next to your computer

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

Companies that provide selfless information through particip

ill you learn the difference.

Lyna. A great website is www.aim.com/acronyms.adp

Fred: TAFN( That’s All For Now

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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