Advice Pool - Reference and Education

1. It's not boring as all get out.

I spent the first 5 and a half years of my education in public schools. There were, of course, times

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

when I enjoyed learning things and talking to my friends. On the flip side, though, there were long stretches of monotony and boredom. And

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

Examples of combination products may in

that was just grade school! I can't even imagine what it would have gotten like in middle and high school. I vaguely remember a class I t

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

ook in 6th grade before I began to be homeschooled. "Conflict resolution" they called it. It was an entire class we had to sit through for

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

50 minutes a day on how not to get in a fight. Instead of teaching us something useful like math, history or science, we had to sit and le

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

Combination pro

arn that getting in a fistfight wasn't good for anybody.

I think it goes without saying that homeschooling was far more interesting. I wa

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

s either doing something and learning, or I was enjoying my free time. I never had to sit through extended periods of monotonous lectures

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

or stare at a chalkboard while a teacher catered to the slowest student in the classroom. I was able to learn at my own pace and enjoy it.

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

2. No one gives you wedgies.

Unless, of course, you have an older sibling and then you might get more wedgies than you can handle. One

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

of the fantastic things about being homeschooled is that there is no awkward social structure that you have to fit yourself into. Unless y

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

ou live in a very complicated family, there are no bullies, no drug addicts and so forth.

Again, the advantage is more than what you don'

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

Following aspects would a

t have to deal with, but also in what you do get. Being homeschooled enabled me to develop much stronger relationships with my parents and

dd to the challenges in developing combination products:

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

my siblings, and I did find a variety of friends through our homeschool group and church and so forth. I found that when I got to college

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

I was able to comfortably communicate with everyone from the older students (some who were even grandparents, coming back for their educat

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

ion) to the younger students and even the professors and staff. None of these people ever gave me a wedgy.

3. Odds are your teacher will

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

probably like you.

I didn't personally ever have issues with a teacher that didn't seem to like me or treat me well, but I do know that

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

Professional from academic institutions, pharmaceutical industries, health care indust

hose experiences are out there. The odds increase, I think, as you get into high school that you might run into a teacher that you either

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

don't like or who doesn't like you for some reason. I wouldn't say that it's anything personal, just sometimes there are personality clash

.

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

es.

On the other hand, I think you benefit from homeschooling because you're able to develop a much deeper relationship with your parents

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

Companies that provide selfless information through particip

. Instead of coming home from school and simply telling them what you did (if you can even remember all the details) you live it with them

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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