E-Articles - Health and Fitness

Risk factors for GDM may be classified into two types: modifiable and unmodifiable (Dornhorst and Ro

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

ssi, 1998). Risk factors over which a woman has no control include maternal age of above 25 years, e

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

Examples of combination products may in

hnicity (e.g. Aboriginal Canadians, African-American, Asian, Hispanic, Indian, Native American and P

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

ima Indians, and probably other indigenous groups), weight prior to pregnancy, parity, and personal

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

nd family history of diabetes. Risk factors which are potentially modifiable include obesity (a body

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

Combination pro

mass index (BMI) more than 27 kg/m2) and further weight gain (American Diabetes Association, 2004; J

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

ones and Stone, 1998; Ostlund, 2003; Scott, 2002). BMI is calculated by dividing weight in kilograms

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

by the height in meters squared.

Other risk factors include a prior low birth weight baby (less tha

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

2,500 g), impaired glucose tolerance, impaired fasting glucose, poor diet, sedentary life style, sm

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

oking, hypertension and other cardiovascular risk factors, and genetic problems (e.g. glucokinase an

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

hepatic nuclear disorder) (Capes and Anand, 2001; Scott, 2002).

There is disagreement about the tr

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

Following aspects would a

atment of GDM, and particularly about the management of minor degrees of glucose elevation or glucos

dd to the challenges in developing combination products:

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

e intolerance (Scott, 2002). There is more than one treatment for women with GDM, including diet con

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

rol, insulin therapy, and exercise. An appropriate diet may accomplish physiologic glucose homeostas

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

s. If dietary modification fails to achieve this, then insulin therapy is begun (Brody, 2003). Catal

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

ano (2003) suggested that insulin therapy is one of the most suitable treatments. It is claimed that

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

Professional from academic institutions, pharmaceutical industries, health care indust

this regimen can reduce fetal macrosomia, but more studies to show the effect on maternal and neonat

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

l health outcomes are needed (Brody, 2003). Association between perinatal mortality and morbidity an

.

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

d abnormal GTT or GDM has been overemphasized (Hunter and Keirse, 1989). Hunter and Keirse (1989) fo

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

Companies that provide selfless information through particip

nd no evidence that insulin therapy improves neonatal outcome and decreases macrosomia in the infant

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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