E-Articles - Health and Fitness

Has someone ever told you that your child or (yourself) display Attention Deficit Disorder symptoms? Many children and adults a

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

re labeled ADD or ADHD because they may display symptoms of the disorder(s), but it does not mean that they have ADD or ADHD.

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

Examples of combination products may in

Attention Deficit Disorder Symptoms are displayed by many people at certain times in their life. Just because someone is h

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

yperactive, impulsive or inattentive does not mean they are ADD or ADHD. Many ordinary people start a task and don't finish it, bl

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

urt things out without thinking, are disorganized in their daily lives, and may be inattentive at times, but it does not always me

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

Combination pro

an they are ADD or ADHD? Of course to determine this, a true diagnosis must come from a specialist.

While at times everyone shows

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

these types of behaviors, there are still several factors and guidelines to determine whether or not someone has ADD or ADHD. <

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

ul>

First of all, it needs to be determined if attention deficit disorder symptoms occurring are inappropriate for the person

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

's age level. The behaviors inevitably occur early in life, usually before age seven and continue for a minimum of six months. Det

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

ermining when the ADD or ADHD symptoms begin occurring is a key factor.

Another factor that must be considered is whethe

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

r or not attention deficit disorder symptoms are creating a handicapped in two or more areas of a person's life. The areas they ha

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

Following aspects would a

ve a tendency to show up in are: home, school and/or playground, community and social settings. So a child that may seem overactiv

dd to the challenges in developing combination products:

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

e at times, and at the same time functions well in school more than likely does not have ADD or ADHD.

Specialist cons

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

ider many factors and resources when diagnosing whether or not a child may have ADD or ADHD. It is not determined by one person, r

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

ather by a team of people, usually parents and professionals in a school setting. Patterns of behavior are determined against a se

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

t of criteria and characteristics of the disorder(s) and are weighed by occurrence and severity of behaviors, among other factors.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Attention Deficit Disorder and Attention Deficit Hyperactivity disorder labels should not be taken lightly. Attention Deficit Di

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

sorder Symptoms can be more prevalent at certain times in a person's life more so than other. There are many immediate circumstanc

.

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

es where a person may display ADHD or ADD symptoms such as a death in the family, a divorce, or any other traumatic time. The symp

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

Companies that provide selfless information through particip

toms may very well be more apparent at these times, but consider the above overall factors first. Also, consult with professionals

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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