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Hepatitis C (HCV) is the most prevalent liver disease in the world. According to the Center for Diseas

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

e Control (CDC), 20-30% of people with chronic Hepatitis C will eventually face life-threatening sympt

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

Examples of combination products may in

oms. Astoundingly, unidentified sources of infection account for a large percentage of Hepatitis C cas

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

es. Most of these unidentified sources are believed to be the result of contact with contaminated bloo

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

d, the virus’s primary mode of transmission. However, of those that are not attributed to blood to blo

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

Combination pro

od contact, some unknown cases may possibly be the consequence of salivary transmission. While other b

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

ody fluids may rightfully raise some concern, such as urine, semen, and vaginal fluids, studies show t

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

hat these substances must contain traces of infected blood for contamination to take place.

Although

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

the virus’s physical measurements are tiny, its concentration is enormous. In fact, compared to HIV, t

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

he concentration of the Hepatitis C virus in one drop of infected blood is much higher. Unlike HIV and

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

other viruses, direct or indirect contact with contaminated blood (such as a toothbrush) yields the H

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

Following aspects would a

epatitis C virus transmissible. As a precaution, individuals with HCV are asked not to share personal

dd to the challenges in developing combination products:

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

items where traces of their contaminated blood may reside.

Despite continued uncertainty, some resear

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

ches have found evidence in support of HCV being transmitted via saliva. That is, if it’s under the ri

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

ght circumstances. For instance, recent research shows that Hepatitis C is only found in the saliva of

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

individuals with high viral loads. It may be possible for individuals with high viral loads to transm

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

Professional from academic institutions, pharmaceutical industries, health care indust

it the Hepatitis C virus through kissing, but the exact risk involved has yet to be determined. Resear

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

ch shows that both people would need to have gum disease in order for transmission to occur.

.

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

t="_new" href="http://www.hepatitis-central.com/mt/archives/2007/03/can_saliva_tran.html" target="_bla

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

Companies that provide selfless information through particip

nk">Click here to learn more about the potential to transmit Hepatitis C through salivary contact.

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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This TQM article is written about a Baldrige Style Assessment in Business Results Category 7 guided by Baldrige Approach. Included are some common assessment findings derived from companies being assessed by a group of trained and experience senior assessors. Reader may benchmark it for their improvement case studies in TQM implementation Project.

We all have to much work and too little time. You can have it great, you can have it cheap, or you can have it fast. Scheduling your projects depends on the due date and working backwards.

When you are selling your home, it is incredibly frustrating to have days, weeks, and even months go by without a sale. Worst-case -- the listing expires without a sale. With increasing average market time to sale, the number of listings expiring each month is on the rise.

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