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Our daughter was diagnosed with Asperger's Disorder when she was 13. This is Part 2 of a 3 part story about our struggles.

The rest of her primary school

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

years were not easy. She was bullied incessantly and because she has a penchant for saying whatever comes into her head and not pulling any punches, she

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

Examples of combination products may in

idn't help herself. The year after we had the psychological test done, she had a teacher who actively disliked her. I was called to the school a number of

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

times as Jess was not co-operating. Initially I felt empathy for the teacher but as time went by and the teacher wanted me to "gang up" on Jess, I really

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

started to question where she was coming from and felt very defensive and also quite helpless. Lots of things happened which are now difficult to remember

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

Combination pro

as there were so many and we really just lived through day to day.

It was during this time that we noticed her intense interest/obsession with certain thi

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

ngs such as James Bond movies, the Parent Trap movie which she watched 52 (note the exact number - she counted) times, Pokemon and flags of countries. She

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

was also fascinated with all things Scottish and at 6 years old taught herself some Gaelic. She was also able to recall dates with amazing ease. When she

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

got a little older her obsession transferred to the rock group Queen. She got on to the Queen forum and was one of their most prolific posters. If you w

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

re to ask what Freddie Mercury was doing at a certain point of his life she would be able to tell you. Actually not just Freddie Mercury but any member of

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

the band!

It was when she was in Year 6 and 11 years old that something happened to prompt us to get some help. Every day we provided her with lunch and

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

Following aspects would a

every day the lunch came home uneaten or was I suspected thrown away at school. She absolutely hated anybody in the family going through her school bag or

dd to the challenges in developing combination products:

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

her room. Her sense of privacy was and still is of the utmost importance to her. On this particular day, I did go through her bag as it was the beginning

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

of the holidays and school bag stank. What I found would have turned the strongest stomach. There were literally a dozen or more uneaten mouldy lunches,

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

some so old and mouldy they were just dust. This prompted me to look in her bedroom, also smelly. We found numerous lunched hidden under her bed, her boo

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

case, her chair and anywhere else where she could reasonably hide things. What we couldn't understand was why she hadn't just thrown them away at school w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hen we would have been none the wiser. This seemed like a cry for help. That day I took her to the doctor who recommended that we phone the local health

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

ervice. We got in to see someone fairly quickly and spent the next 2 years and a bi-weekly or weekly basis talking with a rather nice but ineffective lady

.

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

.

One of the first things the counsellor recommended was that we attend a Social Skills group run by the local University. I asked her after the first se

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

Companies that provide selfless information through particip

sion what she thought and she said "it's ok but they're all weird." We had our funny times too!

Look out for the third and final installment of our story

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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E-Articles - Asperger's Our Story - Part 2

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