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Advice Pool - Aspergers Syndrome
Aspergers Syndrome is a developmental disorder classified under "pervasive development disorder" (PDD). In lay terms this means that individuals with Aspergers Syndrome have delays in development of multiple basic functions especially around
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
socialization and communication. It is estimated that 1 in 277 of all children suffer from Aspergers Syndrome.
Aspergers Syndrome and Autism are different grades in a spectrum of development disorder. It is similar to classic Autism
Aspergers Syndrome and Autism are different grades in a spectrum of development disorder. It is similar to classic Autism
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
in a variety of ways but differs mainly because Aspergers Syndrome individuals are usually higher functioning. IQ tests may show superior intelligence or even a very high memory capacity in individuals diagnosed with Aspergers Syndrome. Som
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e of the differences from Autism include:
□ Onset of symptoms is usually later in Aspergers Syndrome
□ Social and communication deficits are less severe in Aspergers Syndrome
□ Circumscribed interests are more prominent
□ Onset of symptoms is usually later in Aspergers Syndrome
□ Social and communication deficits are less severe in Aspergers Syndrome
□ Circumscribed interests are more prominent
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in Aspergers Syndrome
□ Verbal IQ is usually higher than performance IQ (in autism, the case is usually the reverse)
□ Family history is more frequently positive in Aspergers Syndrome
Due to lack of physical manifestations, an
□ Verbal IQ is usually higher than performance IQ (in autism, the case is usually the reverse)
□ Family history is more frequently positive in Aspergers Syndrome
Due to lack of physical manifestations, an
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d variability in presentation, Aspergers Syndrome is often not identified in early childhood; in fact many individuals are not diagnosed until they are adults!! Although children with Aspergers Syndrome tend to look exactly like other childr
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
en, they behave differently. These results in the following:
□ Siblings feel embarrassed around peers; often times frustrated by not having the relationship they expected with their sibling and most importantly feel angry because chil
□ Siblings feel embarrassed around peers; often times frustrated by not having the relationship they expected with their sibling and most importantly feel angry because chil
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
ren with Aspergers Syndrome require a lot of parent's time.
□ Frustration for parents; Parenting a child with Aspergers Syndrome can be frustrating, tiring and demanding. It is hard enough for parents to understand why their beloved c
□ Frustration for parents; Parenting a child with Aspergers Syndrome can be frustrating, tiring and demanding. It is hard enough for parents to understand why their beloved c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hild has this disorder. It is even more difficult to understand and relate to the child behavior triggered by no "apparent" cause. Child with Aspergers Syndrome may start hitting family members, shout and scream without any apparent cause.
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 a result of this parents and siblings can get overwhelmed in coping with the behavior arising as a result of Aspergers Syndrome. Other times it may even disrupt peace at home. This further worsens the Childs behavior and hence a vicious c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ircle ensues.
Although children with Aspergers Syndrome tend to look exactly like other children, they behave differently. These results in the following:
□ Siblings feel embarrassed around peers; often times frustrated by not having
Although children with Aspergers Syndrome tend to look exactly like other children, they behave differently. These results in the following:
□ Siblings feel embarrassed around peers; often times frustrated by not having
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the relationship they expected with their sibling and most importantly feel angry because children with Aspergers Syndrome require a lot of parent's time.
□ Frustration for parents; Parenting a child with Aspergers Syndrome can be fr
□ Frustration for parents; Parenting a child with Aspergers Syndrome can be fr
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ustrating, tiring and demanding. It is hard enough for parents to understand why their beloved child has this disorder. It is even more difficult to understand and relate to the child behavior triggered by no "apparent" cause. Child with Asp
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ergers Syndrome may start hitting family members, shout and scream without any apparent cause.
As a result of this parents and siblings can get overwhelmed in coping with the behavior arising as a result of Aspergers Syndrome. Other times i
As a result of this parents and siblings can get overwhelmed in coping with the behavior arising as a result of Aspergers Syndrome. Other times i
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
may even disrupt peace at home. This further worsens the Childs behavior and hence a vicious circle ensues. Although there is no definitive "cure" Aspergers Syndrome, treatment is given around the core symptoms of:
□ Poor communicati
□ Poor communicati
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
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
on skills
□ Obsessive or repetitive routines
□ Physical clumsiness
A typical treatment program to Aspergers Syndrome generally includes ;Social skill training; Cognitive behavior therapy; Medications, mainly for depression, an
□ Obsessive or repetitive routines
□ Physical clumsiness
A typical treatment program to Aspergers Syndrome generally includes ;Social skill training; Cognitive behavior therapy; Medications, mainly for depression, an
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
xiety, and ADD/ADHD; Occupational or physical therapy; Specialized speech therapy; Parent training and support
To overview; It is important that parents have a good understanding of what Aspergers Syndrome is? It is important for the child
To overview; It is important that parents have a good understanding of what Aspergers Syndrome is? It is important for the child
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
that siblings and family are explained about the syndrome (to help them deal with it better). Furthermore focused activities should be planned with the child everyday e.g. swimming, shopping etc; Parents should attempt to make the child's ch
.
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
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
ildhood as "normal" as possible (It is tempting for the parents and siblings to cuddle the child with Aspergers Syndrome) - this is important so that the child can have similar childhood as their siblings e.g. sibling rivalry, fighting over
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
toys, TV shows etc. Dealing with a child with Aspergers Syndrome can get challenging. With some help and guidance, it can help the parents and the child a long way, in how to deal with day to day scenarios and to keep peace in their families
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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