Advice Pool - Health and Fitness

If you are old enough, you will remember a time when you could only test your blood glucose levels through your urine. And testing this way was

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

not even a reliable and accurate indicator of the levels of glucose in a person's body. Thanks to advancements is technology, we can now receive

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

Examples of combination products may in

an instant, and much more accurate reading with a single drop of blood.

There are currently two kinds of blood tests available to test a person'

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

s blood glucose levels. These tests are actually “test strips.” The test strips allow blood to react with an enzyme that is on the strip. The

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

reaction of the blood on the enzyme with one strip will create a color. A meter will then read the color on the strip, with this reading resulti

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

Combination pro

ng in the glucose reading. The blood sample on the second test strip results in the production of electrons. A meter is again used to read the

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

mount of electrons, and these results will display the glucose reading.

One of the questions most frequently asked regarding the testing of your

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

blood glucose levels is - just how often should you test? There is no one answer to that question that would apply to all diabetics. The freq

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

ency of glucose testing will depend on the type of diabetes being treated, the stability of your blood glucose, and the particular treatment plan

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

being followed.

Here are some general time indicators for testing your blood glucose levels:

1. People with type 1 and/or type 2 diabetes who

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

nject insulin, must test their blood glucose levels before meals, and again before bedtime. This frequency of testing, that spreads throughout t

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

Following aspects would a

e day and into the evening, can be very inconvenient. However, a diabetic can't actually "feel" whether their glucose levels are regular or not.

dd to the challenges in developing combination products:

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

Unfortunately, this regular testing is necessary. With the potential for a diabetics blood glucose levels to rise and fall very quickly, witho

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

t these frequent tests it could cause additional health damage.

2. Type 2 diabetics who are fairly stable, and on a successful treatment plan co

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

nsisting of taking medications, a steady diet of good foods, and regular exercise should only need to test their glucose levels twice a day. G

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

nerally, these testing times will be just before eating breakfast and then again before dinner.

3. There are also optional reasons for testing y

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

Professional from academic institutions, pharmaceutical industries, health care indust

our blood glucose levels. Remember, there is never a bad time to test; frequent testing allows you to remain in control of your overall conditio

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

. Here is an example of an optional blood test; should you want to eat something that is not exactly within the guidelines of your diet, you may

.

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

take a test to see your current blood glucose levels and just how indulging in this treat may affect your glucose levels. Testing just prior to

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

Companies that provide selfless information through particip

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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Advice Pool - Monitoring Your Blood Glucose Levels

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