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A study by Stickle and Blechman (Journal of Psychopathology and Behavioral Assessment, 2002) found that fire setting was associated with early on

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

set severe and varied antisocial behaviors among juveniles. A new study by Seifert examined the characteristics of a group of 153 fire setters.

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

Examples of combination products may in

ire setters were defined as youth who set fires that are not of a utilitarian nature and may have a risk of harm to others.

There appear to be t

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

o groups of fire setters: aggressive and non-aggressive. Aggressive youth are those who have hit, pushed or shoved another person that is not in

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

self defense and causes some level of distress to the victim. Non-aggressive fire setters do not have a history of hitting others. The non-aggr

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

Combination pro

ssive group appear to have more psychiatric problems, while the aggressive group are similar to the severe behavior problem group with multiple p

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

oblems and childhood trauma. The aggressive fire setters ranged in age from 6 to 19 (average age was 14), while the non-aggressive fire setters

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

ranged in age from 8 to 16 (average age was 13).

Among the aggressive fire setters, all had a history of moderate to severe behavior problems an

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

assaultive behaviors, 97% had behavior problems that began before the age of 13, 87% had one or more parents not involved in the child’s life, 8

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

% had poor social skills, 83% had a history of family violence, 82% had a history of childhood trauma, and 76% were delinquent. For the non-aggr

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

ssive fore setter group 94% had a history of moderate to severe behavior problems, 89% had poor social skills, 89% had anger management problems,

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

Following aspects would a

83% were impulsive, 74% had moderate to severe behavior problems before the age of 13, 72% had average or better IQ, and 72% had psychosis or sel

dd to the challenges in developing combination products:

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

harm.

Looking at the characteristics of these two groups, it becomes clear that the intervention strategies may be different for youth in aggre

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

sive vs non-aggressive patterns. The aggressive group has more trauma and histories of family violence. Therefore therapy would need to address

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

any ongoing home violence or trauma and use techniques to help the youth heal from past trauma, including domestic violence. Both groups have s

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

me social skill deficits and cognitive behavioral treatment for skill building would be appropriate. The non-aggressive fire setter may have mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

psychiatric problems and will need a psychiatric evaluation, especially for psychosis, self harm and impulsivity. The majority of both groups h

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

d average or better intellectual functioning, but examination of how they are doing in school is always appropriate.

In conclusion, as in most g

.

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

oups of behaviorally disordered youth, comorbidity, family, and trauma issues need to be examined in order to provide the most effective therapy.

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

Companies that provide selfless information through particip

An effective assessment on the front end can save time and trouble later on. Early intervention (before the age of 12) is of primary importance

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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