Advice Pool - Reference and Education

Wikipedia states that “Home education, also called homeschooling or home school, is an educational alternative in which children are educated at home by their parents, in contrast to

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

the compulsory attendance which takes place in an institution with a campus such as a public school or private school.”

Around the world Homeschooling has been increasing quite sub

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

Examples of combination products may in

tantially over the last 4 years. In 2003, in the United States, approximately 1.1 million children were Home Schooled, up 29% from 850,000 in 1999. Recent figures show that Homescho

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

oling in other Western Countries are also continuing to grow. For example, an estimated 50,000 children are considered "home-educated" in the United Kingdom; Australia - 26,500; and

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

n Canada (as at 2001) it was estimated that 80,000 children were educated at home with the numbers continuing to increase.

Most home education advocates have individual motivations

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

Combination pro

o home-educate. Academic and social results of home education are varied and are the source of vibrant debate. Some feel that they can more effectively tailor a student’s academic p

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

rogram to suit an individual strengths and weaknesses, especially children who are gifted or have learning disabilities. Others are religious parents who see non-religious education

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

s contrary to their moral or religious systems. Still others feel that the negative social pressures of schools, such as bullying, drugs, school violence, and other school-related pr

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

blems, are impacting negatively to a child's development. Many parents simply like the idea of teaching their own children rather than letting someone else do so.

A common concern v

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

oiced about home-educated children is they lack the social interaction with students and society that a school environment provides. Many home-education families address these concer

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

s by joining numerous organizations, including home-education cooperatives, independent study programs and specialized enrichment groups for physical education, art, music, and debat

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

Following aspects would a

. Most are also active in community groups. Home-educated children generally socialize with other children the same way that school children do: outside of school, via personal visit

dd to the challenges in developing combination products:

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

s and through sports teams, clubs, and religious groups.

The academic effectiveness of homeschooling is largely a settled issue. “Numerous studies have confirmed the academic integr

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

ty of home education programs, demonstrating that on average, home-educated students outperform their publicly-run school peers by 30 to 37 percentile points across all subjects.” Th

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

performance gaps between minorities and gender that plague publicly-run schools are virtually non-existent amongst home-educated students.

Notable home-educated individuals

• Thom

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

as Edison, United States, scientist and inventor
• Alexander Graham Bell, Scotland, Inventor (Telephone, Hydrofoil)
• Dakota Fanning, United States, actress
• Hilary D

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

Professional from academic institutions, pharmaceutical industries, health care indust

ff, United States, Actress/Singer
• Charles Evans Hughes, United States, Governor of New York, United States Secretary of State, and Chief Justice of the United States
• Fr

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

nkie Muniz, United States, Actor
• Rosa Parks, United States, civil rights activist
• Susan La Flesche Picotte, United States, first American Indian woman physician
•

.

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

Woodrow Wilson, United States, the only United States President to hold a Ph.D.
• George Washington, United States, First United States President
• Abraham Lincoln, United

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

Companies that provide selfless information through particip

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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