Advice Pool - Reference and Education

My son was home schooled from 4th through 12th grade. As part of his education, his father and I wanted to teach him about the importance of character d

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

evelopment.

I visited some home school curriculum fairs and there was little available about character development. What did exist was often part of a

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

Examples of combination products may in

scouting type of program, including such things as camping, crafts, sports and cooking. That wasn't what necessarily our focus, so I set about creating s

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

omething useful for our family. What resulted was both fun and educational for us all.

First, I wrote a list of character traits I thought were importa

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

t. Next, I checked the Bible, some sources of great literature, and some biographical works about famous and great individuals in history, to see which c

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

Combination pro

haracter traits they possessed. Finally, I searched for local field trips available, games we might create or play, art projects, etc. that might have an

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

ything to do with developing character. Our program, instead of being a scouting type of study in character, became more of a Bible study and study of h

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

istorical figures.

These are some of the character traits I felt were important:

Caring
Committed
Compassionate
Competent
Confident

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

br> Considerate
Dependable
Fair
Faithful
Friendly
Hard-working
Honest
Loyal
Patient
Peaceful
Prompt

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

> Respectful
Responsible
Self-controlled
Sensitive
Sincere
Tactful
Thorough
Thoughtful
Tolerant
Truthful

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

> Understanding

Each week, our study focused on a specific character trait. On Monday, my son would define the trait of the week. On Tuesday, he

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

Following aspects would a

searched the Scriptures to see what he could find about that particular trait. Wednesdays focused on the teachings of Jesus, things Jesus might have said

dd to the challenges in developing combination products:

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

or parables he used pointing to that trait. On Thursday, great men and women in history were studied to find out which ones exhibited the trait being stu

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

died. Additionally, my son wrote a short paragraph about individuals he observed in our community who had exhibited our trait of the week. He would also

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

wrote about how he had exhibited or practiced that trait, or he would create a plan to try to do something showing that he possessed that trait.

Our Fr

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

idays almost always consisted of just two things - tests and fun. First, we would test on progress on all of his academic subjects. Then we'd embark on s

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

Professional from academic institutions, pharmaceutical industries, health care indust

me fun - creating our own games, making trips to museums and art galleries, bowling, roller skating or whatever, as we searched for ways to recognize and

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

reinforce our character trait study.

Not surprisingly, my son was soon searching for the goodness in those around him and pointing out when those aroun

.

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

d him showed compassion, self-control, honesty and such.

It has been years since we followed this study, but my son still judges people on these importa

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

Companies that provide selfless information through particip

nt traits, rather than on their outward appearances. And he still works each day to see how he can continue to develop into a man of strength and wisdom

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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