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Awareness of your surroundings is the key to effectively defending yourself against assault. Now I kn

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

ow their are people who would say, " I'm a trusting person, I don't think about things like that!". Y

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

Examples of combination products may in

ou can arm yourself with tools to effectively defend yourself but if you are oblivious to your surrou

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

ndings you can be taken by surprise and those tools never come into play.

If you are alone, at night

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

or in the daytime, (please don't make the mistake of thinking assaults only take place at night), yo

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

Combination pro

u should make a practice of looking around you and preparing yourself for the what ifs? Always be awa

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

re of your surroundings! I can't stress that enough. If you are walking to your car in a parking lot

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

ate at night, look around you.

Carry a small stun gun or pepper spray or a loud personal alarm and k

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

eep it in your hand until you are in a safe place where you can't be surprised. Again, you can carry

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

these items on you , (maybe a stun gun in your purse or pepper spray on your key ring) but if someone

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

is able to sneak up and grab you before you have a chance to prepare yourself, well. I know life can

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

Following aspects would a

be distracting, talking on a cell phone or thinking about your next class or whatever.

Do yourself

dd to the challenges in developing combination products:

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

a favor, BE AWARE, BE PREPARED. Arm yourself with the tools and then be prepared to use them. Hopeful

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

ly you never will. Also, be suspicious of people you don't know well. I'm not saying that you should

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

uspect everyone you happen to come in contact with of being a "bad guy" but you should be wary of peo

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

ple you don't know well. Remember, most victims actually know their attacker. Most people don't think

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

Professional from academic institutions, pharmaceutical industries, health care indust

about these things until they or someone they know is attacked. Don't wait, prepare yourself now.

I

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

f more people did, maybe the human waste that preys on human beings would think twice before their ne

.

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

xt assault. My sincere hope is that my words or the words of others that preach prevention and prepar

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

Companies that provide selfless information through particip

ation will help raise awareness. If I can help to stop ONE assault from happening, I have done my job

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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