Advice Pool - Health and Fitness

Many people ask why autism seems to be so much prevalent today than it was years ago, but unfortunately while there are significant am

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

ounts of speculation to that question, there are no definitive answers.

We know that today, approximately 1 out of every 160 children

; 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 affected with autism to varying degrees. Perhaps our measurement of what defines autism has grown more granular where even very m

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

ild cases of autism that were not counted years ago are now included in that figure. Many people believe that years ago, we spent too

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

much time just assuming that the child was naturally withdraw or anti-social instead of recognizing those symptoms as being signs of a

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

Combination pro

utism.

We know that boys are more affected with autism than girls by a significant ratio, and perhaps years ago it was thought just t

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

be a gender difference in the rate of maturity of boys versus girls.

Finding out what causes autism and what can be done to prevent

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

it or treat it has become a major priority in the medical and scientific community. Many children are "losing their childhoods" becau

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

e of autism, and despite their parent's best efforts to help them, many only reach of state of marginal self-reliance as they grow old

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

er.

Although it is commonly accepted that autism is a neurological disorder, there are many theories as to what constitutes a "concre

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

e sign" of the existence of autism in a young child, especially a child who is young enough to not fully understand what is supposed t

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

Following aspects would a

o be "normal" versus abnormal. It is known that autistic children frequently have chronic diarrhea and frequently have trouble keepin

dd to the challenges in developing combination products:

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

food down. Would that indicate that the intestines are somehow involved in providing a sign? Although that aspect has been studied,

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

the results are as yet inconclusive. Autistic children also frequently have more occurrences of colds, earaches, and allergies, so d

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

es that mean that the child's immune system is trying to tell us something? Again, this aspect has been studied and the results to da

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

te are inconclusive.

Could autism be caused by some chemical that is commonly used in our modern day environments? Again, this is a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ossibility, but the lack of funding has permitted the study of only about 30 to 40 of the more than 80,000 chemicals that may commonly

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

be found in most environments, so that question is still up in the air.

Your best bet at this point is to watch your child for signs

.

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

of autism and if seen, to get a professional diagnosis as soon as possible. If your child has autism, work with the teachers at their

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

Companies that provide selfless information through particip

school to form a team to accommodate their special needs, which can aid in minimizing the effects of autism until a cure can be found

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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