Advice Pool - Health and Fitness

Diagnosis is a confirmation of GDM in people with a positive screening test.

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

There are several tests for the diagnosis of GDM, but the most commonly tes

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

Examples of combination products may in

t is OGTT. And what is OGTT? Usually OGTT is performed in women at an incre

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

ased risk. For example, in women with previous GDM, the OGTT is performed ea

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

rly after diagnosis of gestation (Bartha, 2003) or when GDM is identified on

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

Combination pro

a screening test.

For the diagnostic test, many hospitals in Australia use

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

a 75g OGTT. Fewer hospitals use a 50g OGTT and 100g OGTT (Rumbold and Crowt

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

her, 2001). The requirement of elevated blood glucose levels also differs be

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

tween Australia hospitals (the requirement ranges between 1-3 elevated blood

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

samples). There is also variety in the management for GDM. Regimens include

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

self-monitoring of blood glucose level, laboratory monitoring of blood gluc

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

Following aspects would a

ose level, exercise, diet control, and a combination of diet and insulin the

dd to the challenges in developing combination products:

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

rapy (Rumbold and Crowther, 2001).

Glucose load and timing also vary in dif

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

ferent places around the world (Scott, 2002). In some countries, where large

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

glucose loads are used, women may feel uncomfortable using 75 g glucose-loa

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

ds (Scott, 2002). Moreover, the test results are less satisfactory with this

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

Professional from academic institutions, pharmaceutical industries, health care indust

higher load than with lower loads (Scott, 2002). There are also side effect

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

s with the high concentrated glucose load, for example nausea, vomiting 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

bloating may affect the test results (Murphy, 1994; Shushan and Samueloff, 1

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

Companies that provide selfless information through particip

998). Different timing of assessment also influences the results of the test

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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