Advice Pool - Reference and Education

Many people describe home schooling as 'do it yourself education' and most parents immediately assume that they are the 'you' in 'yourself'. As a result, many par

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

ents with busy lives earning a living or pursuing other important activities, and particularly single parents, tend to dismiss any thoughts of home schooling out

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

Examples of combination products may in

f hand. But are they right to do so?

Home schooling has been around for a long time now and involves more than one million children in the US alone and experienc

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

means that are many options open to parents today. Indeed, it is perhaps no surprise to find that parents in just about every situation you can imagine have foun

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

the solution to home schooling their children.

We are all of course familiar with the traditional two parent family with dad out at work and mum looking after t

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

Combination pro

e home and this situation makes home schooling a relatively simple option. Since the 1960s however society has changed a great deal and today there are a whole sp

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

ectrum of family situations including role reversal, single parents, same-sex couples, extended families and much more.

Each situation brings with it both proble

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 and advantages for home schooling and it is a matter of examining both and then looking for ways to overcome the one and enhance the other.

For example, many f

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

milies turn to their wider family or friends for help and invite family or friends into their home to help. This is nothing new of course and, for many years, it

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

as common for families to offer a friend or an older family member like an uncle, aunt or grandparent accommodation in exchange for helping with the care and educ

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

tion of the children.

Neighbors can also often provide assistance. A number of 'stay-at-home' moms are already providing day care facilities for children and, as

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

Following aspects would a

home schooling continues to spread, babysitting services are increasingly being extended to include home schooling.

In many cases families are also getting toge

dd to the challenges in developing combination products:

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

her to provide home schooling on a 'group' basis with parents pooling their resources and time.

Another popular option is to employ a tutor. Tutors today come fr

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

m a wide range of different backgrounds and in all age groups and include both specialists, such as those teaching languages or music, as well as general tutors.

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

n fact, it is quite common to find ex-public or private school teachers who have become dissatisfied with the 'system' turning to tutoring because of their fundam

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

ntal love of teaching.

Most parents think that private tutoring is simply beyond their financial reach but, after some careful research, they are often surprised

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

Professional from academic institutions, pharmaceutical industries, health care indust

to learn that the cost of hiring a tutor can indeed be within their reach.

One other important consideration is the children themselves. It is surprising how we

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

l motivated children are by the independent nature of home schooling and many parents find that teaching a child at home can take considerably less time than you

.

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

ight think.

If you find yourself tempted by the advantages of home schooling over the present poor public school system then do not fall into the common pitfall

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

Companies that provide selfless information through particip

f dismissing the idea out-of-hand. Take the time to explore the options open to you and you may well be surprised to find that it is not as difficult as you think

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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