Advice Pool - Health and Fitness

One of the hazards that go with child diabetes is how to maintain medicatio

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

n even at school. Kids with diabetes are also expected to at least live a normal life and th

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

Examples of combination products may in

s means taking part in various school activities and performing tasks independently free fro

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

worries of sudden diabetes attacks.

Parents of children with diabetes hav

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

e to coordinate with the school administration in order to make them aware of the child's co

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

Combination pro

dition. This way the school may be able to prepare some child diabetes supply
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
> to cope with sudden emergencies.

Here is the list of child diabetes supply
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
g> that schools must prepare:

A. Basal/Bolus Supplies

• Blood glucose meter
• Test st
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ips
• Lancet device
• Lancets
• Ketone strips
• Glucagon emergency kit
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
> • Insulin pen
• Pen needles
• Syringes
• Insulin
• Extra pump supplie
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
(insulin pump users)
• Supply of snacks/items to treat low blood glucose

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

Following aspects would a
ar Supplies

• Blood glucose meter
• Test strips
• Lancet device
• Lancets
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
• Ketone strips
• Glucagon emergency kit
• Insulin
• Syringes
• Suppl
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
of snacks/items to treat low blood glucose

Aside from ensuring the presence of chi
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ld diabetes supplies, it is also a good idea for the school to have designated trea
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
ment areas for diabetic kids. There should be an area which is specially intended to store <
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
trong>child diabetes supplies. Likewise an area where blood glucose levels can be t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ested should also be reserved.

The school should also provide a regular report of b
.

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
ood glucose tests to the parents. Similarly a system should also be developed that
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ould keep track of recurrent absences or requests to be excused from classes due to diabetes

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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