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I was once a child not so long ago, so I know first hand what children with crohn’s disease should expect. From a parents point of view the health of t

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

heir child is very important and being told your child has crohn’s disease can be a great shock. The child’s health is the main concern of all parents

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

Examples of combination products may in

and the only way you can help your child is by being extremely attentive and supportive.

What Is Crohn’s Disease and what are the symptoms?

Symptoms

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

of crohn’s disease in children varies from child to child but I will try and explain what it was like for me. At the age of eleven years old I complain

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

ed of stomach cramps and my mother and I were continually going back and forth to the doctors surgery. Each time we were told that it was ‘growing pain

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

Combination pro

s’ and that they would subside as I got older. They did not subside, in fact they got steadily worse.

By the age of fourteen I had lost lots of weight

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

, I lost my appetite and the stomach cramps and diarreah were unbearable. I was then admitted to hospital for tests. This is when they told me that I h

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

d a bowel disease which affects the intestines, the digestive tract, stomach and anus.They also told me that this was an incurable disease and crohn’s

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

disease in children was rare.

Crohn’s disease in children can occur as early as seven and once treated can reoccur several times during the life span.

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

It is not known precisely what causes Crohn’s disease in children or adults; from a weak immune system to stress are all on the list of possibilities.

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

As my disease was not detected very early it also affected my growth.

Diagnosing And Treating Crohn’s Disease

After I was diagnosed I had to undergo

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

Following aspects would a

months of steroid treatment, blood tests, endoscopy, colonoscopy and biopsy’s. Crohn’s disease in children is very upsetting and confusing. I had to h

dd to the challenges in developing combination products:

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

ave almost two years off school. Children who are diagnosed with crohn’s disease should consider a private tutor to ensure they do not fall behind in t

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

heir work.

Once the diagnostic is obtained the treatment can begin and depending on the diagnostic there are a few ways to approach the treatment of C

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

ohn’s disease for children even though there is no cure achieved so far for the same. The most common approach is to control the inflammation and relie

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

ve the pain; there is no specific diet for Crohn’s disease but you can control any deficiencies found in your child’s present diet as well as the docto

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

Professional from academic institutions, pharmaceutical industries, health care indust

r can prescribe medication in case of diarrhea or other stool disorders. After the steroid treatment, I had to have part of my intestine cut out which

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

resulted in a long stay in hospital followed by a diet of revolting tasting milkshake drink for what felt like weeks on end. I am now 34 years old and

.

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

have controlled my disease by taking herbal supplements such as Aloe MP Plus. My life has changed since taking this and I would recommend it for crohn

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

Companies that provide selfless information through particip

’s disease in children as it is all natural with no side effects. I just wish I had known about it when I was diagnosed as a child with crohn’s disease

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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