Advice Pool - Health and Fitness

It is no secret that children can be cruel and a child that does not appear to fit in can be the subject of taunting and ridicule. This present a major

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

problem for the child and his parents as the child will have trouble making and retaining friends and other social interactions, and the child with Asp

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

Examples of combination products may in

rgers Syndrome can be adversely affected.

First of all, please understand that just because your child has Aspergers does not mean that they are intell

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

ectually limited. Various studies in fact have indicated that children with autism and Aspergers are actually very smart, many times being intellectual

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

y superior to their peers of the same age group. Unfortunately, the social interaction part of their maturity has fallen behind the rest of their matur

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

Combination pro

ing process, which presents the parents with another challenge along the same lines. In other words, they are probably not intellectually challenged, b

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

t simply "socially challenged", and the best thing you can do as parents is to work with them to help them overcome that aspect.

One of the best things

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

you can do as parents is to do role-playing activities or scenarios which would reflect a natural social environment such as another child's birthday p

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

rty or pool party or similar setting. Work with the child to help them understand how to join in with the playground games, how to converse with their

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

playmates, and what is and is not expected of them in this type of setting. Helping them to become comfortable in this type of setting can go a long wa

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

s towards helping them fit in when they participate in actual events with their peers.

Children with Aspergers and autism will face internal anxiety if

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

Following aspects would a

they cannot accept their current surroundings. Try to teach them not to obsess about objects or any preferred items or activities. Work with them to

dd to the challenges in developing combination products:

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

ind out what calms them so that anxiety can be subdued and controlled.

Normal everyday life at school can present its own unique set of challenges, sin

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

ce social interaction is a normal part of school life. Be sure to let the teachers know about the Aspergers or autism in your child so that they can ma

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

e accommodations for them as they are able to. Most schools are happy to work with you and your child in this respect, but it will take effort on both

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

parts. Work with your child at home to help them become comfortable with social interactions, perhaps starting with just one friend on a one-to-one bas

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

Professional from academic institutions, pharmaceutical industries, health care indust

s and then increasing to more friends. Put them in an environment, even in your role-playing, where they will see and recognize success, instead of put

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

ting them in a situation where failure is inevitable.

Children with Aspergers or autism need to be given extra chances to make and retain friends, buil

.

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

social networks, and understand what is acceptable for interacting with others. If you can work with them in a role-playing environment, it will be eas

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

Companies that provide selfless information through particip

ier for them to learn these skills. Do not force them, but rather be positive and supportive so that they will not dread any future social interactions

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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