Advice Pool - Reference and Education

I spent the first few years of my son's life reading a lot of books about parenting and quite a few about homeschooling. I remember thinking something along the lines of "it's great that people can do that with their children, but I don't know i

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

f I could." Especially since my son was an only child, I didn't feel that family, friends, and acquaintenances would be supportive of him spending so much time with only me. But I loved sharing books with him and teaching him new things, playin

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

Examples of combination products may in

imaginative games and making up novel ways to learn. Always the dutiful mom wanting to do the right thing, however, I visited preschools, found a great Montessori school, and enrolled him. That worked fine and still left us more than enough ti

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

e to learn together.

Fast forward a few years, though, and we found ourselves living in a different state, in a county with an overcrowded school system, with middle school rapidly approaching. I was already disappointed in the elementary schoo

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

he was getting ready to leave, because despite his achievements and fine grades there, I saw gaps and deficiences in his learning that I could not easily help him repair with the very few hours left over to us at the end of each's day's classes

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

Combination pro

and activities, especially when we both were tired. He was doing advanced grade mathematics and yet needed to use his fingers if I asked him to do a quick calculation at the supermarket. When he wrote anything longer than a phrase, he committe

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

multiple spelling errors. And while he had hours of "creative" homework, his foundation in basic skills seemed shaky. What was really frightening to me is that his academic weaknesses seemed to grow after he had just spent two years in "gifted

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

classes and now he was scheduled for all six of his middle school classes to be "gifted" classes.

The middle school turned out to be even more overcrowded than the elementary school. Homework began to take up to five hours each evening, depriv

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

ng my son of time for reading books of his own choice and threatening to leave him no time to attend his beloved weekly theatre group. It just didn't seem right, especially since he seemed to be learning more from the books he read on his own an

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

d was gaining incredible poise and speaking ability from participating in the theatre group. Seven weeks into middle school, after I had suggested it several times, he came home from school one day and basically said, "I don't want to go back th

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

re; I'll try your idea to homeschool".

We agreed to homeschool as a one-year experiment. I will admit the first weeks were rough on both of us. I lay awake at night wondering if I was ruining his life. He, on the other hand, was in the proces

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

Following aspects would a

of "deschooling", though at the time I had never heard the term and wondered why he didn't want to get off the couch and do all the fun learning things I had planned. He had seemed depressed in the middle school and now he still seemed depresse

dd to the challenges in developing combination products:

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

. But within three or four weeks, we found a homeschool support group that met weekly at a local park. I was able to talk to parents with experience in homeschooling, and he was able to see there were other kids like him and that he had a place

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

to make new friends. A few weeks later, he told me he did not ever want to go back to that middle school, so that we would do this through eighth grade. Six months later, he took a homeschool coop class in algebra and met homeschooled high-sch

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

olers. Then, he went a step beyond as far as I'd ever thought about, announcing he also wanted to homeschool high school.

So here we are today, on the threshold of eleventh grade. It's been an incredible journey and sometimes I am as amazed as

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

anyone that it has worked fine. After the first year, it got much, much easier. We learned about one another's expectations, made compromises, and, in time, he became the self-motivated learner he had been as a pre-schooler all over again. Whi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e I did teach during those middle school years, I find for high school I am more the guidance counselor, the curriculum consultant, and the recordkeeper.

I'm writing this for all parents who were like me, daydreaming about homeschooling but wond

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

ering if they could really do it. I remember once during the summer after my son's fourth grade year thinking that he was one-third of the way to the end of high school and that there was SO much I wanted to tell him, teach him, share with him,

.

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

nd pass onto him in the eight years that were left, but that with school and social activities it seemed there would never be enough time. Well, let me tell you, without "real school", I've been able to do all that telling, teaching, and sharing

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

Companies that provide selfless information through particip

in just the last five years....all of it. That feeling of not enough time has gone, replaced with the knowing that whatever the future brings, I've given him the experiences, the knowledge, and the foundation I wanted him to have. Seize the day

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 - Starting Homeschooling in the Middle Grades

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