Advice Pool - Reference and Education

Like many middle-school-aged boys, my son despised writing assignments when we began homeschooling. Having been forced to do voluminous writing assignments wh

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

en he was still attending school, his initial reaction when I became his teacher was to protest and argue over every writing assignment I gave him. After much

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

Examples of combination products may in

trial and error, I found that the best approach was to give him a lot of latitude in choosing the topics and even what days he would write, at least in the beg

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

inning. When months began to pass and his writing skills were still weaker than I thought they should be for someone his age and given his abilities in other

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

cademic areas, I decided I had to induce him to practice writing more but also had to make it fun. If I didn't, we were going to have struggles over every sen

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

Combination pro

ence that ever reached the paper.

One of my first successful ideas was to let him register at Amazon.com to write reviews. Since he is an avid collector of b

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

oth books and action figures, he was excited about the opportunity to share his views on which ones were worth the money and which weren't. Especially on the

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

opic of action figures, he would happily write several paragraphs on the details of the paint colors, the articulation of the limbs, etc. Our original agreeme

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

t was that I would not look at the reviews until they were finished, but he would not submit them until we went over them together to check spelling, grammar,

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

punctuation, etc. Initially, the spelling and punctuation left a lot to be desired, but he was a lot less resistant to learning to fix these when he knew the

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

inished product could be viewed by anyone on-line. He was also eager to get the reviews posted, because he could then read how many other customers found his

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

Following aspects would a

omments helpful. Every time he read a new book or bought a new action figure became an opportunity for another writing lesson. Enthusiasm is truly a great te

dd to the challenges in developing combination products:

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

acher because, within six months, his writing (and spelling) had improved drastically. Within another few months, I was able to let him post the reviews befor

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

I proofread them (though occasionally a spelling or punctuation slipped through).

Another successful idea, since he is more an artist than a writer, was to g

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

ve him English assignments that involved drawing. One idea, for instance, after we had just returned from a vacation, was to design a brochure for his ideal v

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

acation resort and hotel. His enthusiasm for the drawing totally overcame his reluctance about the writing, and he ended up doing a truly awesome job. In add

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion, we combined mathematics into the assignment by having him make one page of the brochure a price listing for various services with different combined pack

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

ge rates.

I always suggest to parents who are trying to get younger children to be more proficient in reading that they pick their child's obsession, be it di

.

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

nosaurs, cars, or princesses, and check out every book in the library on that topic and nothing else until the child becomes more enthusiastic about reading.

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

Companies that provide selfless information through particip

o learn to enjoy writing as well, a child needs to be writing about something he or she cares about. Find your child's passion and let literacy flow around it

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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Advice Pool - Teaching Writing to a Reluctant Writer

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