Advice Pool - Reference and Education

Despite being a viable alternative to traditional classroom setting, there are still some people who feel that

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

Homeschooling is not for everyone. Like many things, this new system of education has its disadvantages. Here

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

Examples of combination products may in

are some of them.

1. When you decide to put your kids to homeschooling, you have to be prepared to spend all d

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

ay with your children for several days. With homeschooling, you have to be their teacher. You have to be there

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

o supervise their lessons and even check on their progress. You also have to think of activities and make works

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

Combination pro

eets. This is why most parents would leave work to go fulltime in teaching their kids.

2. Deciding on homescho

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

oling will mean that you have to go against the norm. Be prepared to be grilled by other parents. You should al

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

o be prepared to find some difficulties when you do decide to put your kid back to mainstream. Adjustment will

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

e hard as they will not be used to the environment that traditional education has.

3. Spending 24 hours of the

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

day with your child and being their teacher is no joke. At the beginning, you really have to be patient with y

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

ur child as he or she will not always understand the lesson as fast or as easily as you want. Do not lose your

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

Following aspects would a

emper because this will only make matters worst. Remember that it is just normal for your kid to be behind in s

dd to the challenges in developing combination products:

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

ome subjects or to take a longer time understanding lessons.

4. Most would think that a homeschooling educatio

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

is cheaper. This is not the case. Although you are not paying for any tuition fee, you have to shell out money

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

for the materials that you will be using. Also, a parent may need to quit his or her job to become a full-time

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

teacher. This can pose a problem in the finances especially if both incomes are needed to make both ends meet.

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

Professional from academic institutions, pharmaceutical industries, health care indust

5. Being a teacher is not an easy task. Not only will you have to patient with your child but you also have to

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

ut an enthusiastic appearance even when you are not really in the mood to teach them their lessons. It is impor

.

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

tant that you make the lesson appear fun and interesting for them so that they will be interested to learn. Whe

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

Companies that provide selfless information through particip

they see you bored stiff, they will also follow suit, making your task of teaching them all the more difficult

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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