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Autism is on the increase around the world, with current estimates ranging from one in a thousand to one in five hundred children affected. No one knows exactly why th

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

e numbers are going up. The old theory of vaccines causing the problem has been largely discounted, while other theories encompassing viruses, antibiotics, nutrition 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

d environmental pollution wax and wane.

Because autism is a baffling and difficult problem to treat, many parents are turning to alternative therapies to try and help

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

their children. The western orthodox approach to treating children with autism has ranged placing them in care to working on improving their social and communication s

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

ills. There is no ‘cure’ as yet for Autism, leading some parents to try alternative therapies for symptomatic relief and possible improvement in the condition of their

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

Combination pro

children. One popular recent approach is acupuncture, even though autism as defined by western medicine is not recognised by Traditional Chinese Medicine.

Anecdotal a

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

nd preliminary medical evidence suggest that children with autism can benefit from acupuncture. While a cure is not to be expected, acupuncture seems to give symptomat

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

c relief to children.

Though it may be a challenging experience for the child and the parents in the beginning, the results seem to suggest that it is helpful in the l

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

ong run. Traditional acupuncture requires the patient to lay still for long periods, to endure the close contact of a stranger and the invasive insertion of needles, a

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

l of which could prove to be exceptionally difficult for a child, particularly one on the severe end of the autistic spectrum. But Paediatric acupuncture addresses som

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

of these issues. Acupuncture for young children doesn't require them to lay still as with adults. It's just a quick prick (with super thin needles) at pressure point

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

Following aspects would a

s. Acupressure is an alternative for those who would prefer a less invasive treatment.

A study was done in the US to observe the effect of acupuncture on the brains o

dd to the challenges in developing combination products:

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

children with autism. The acupuncture treatment was given once every other day, for four months. After acupuncture treatment; of the 22 cases, 20 had remarkable impr

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

ovement and 2 had significant in cerebral blood flow. Before the treatment there were significant differences in blood flow between the left and right cerebrum and bet

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

een the left and right frontal lobes, however, after treatment, no differences were found between them

Preliminary clinical trials have been conducted in Hong Kong to

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

stablish the effectiveness of tongue acupuncture – a relatively new treatment method that is thought to be particularly effective for children on the autistic spectrum.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Traditional acupuncture has been practiced in China for over 5000 years, but tongue acupuncture has developed only over the last two decades.

Based on the traditiona

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

Chinese view that the tongue and heart are connected through meridians that spread to all the organs of the body, it is believed that points on the tongue influence th

.

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

e state of the body’s organs and it is through this that relief of autism’s symptoms occurs.

Most agree that a combined approach to diet and alternative therapies can

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

Companies that provide selfless information through particip

ffer symptomatic relief to suffers of autism, improving mood and communication skills in children. Though it will always be on a scale of improvement, rather than cure

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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