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What is Hepatitis A - Hepatitis B - Hepatitis C:

Hepatitis A - An inflammatory viral disease of the liver with a short incubation period. Hepatitis A may be transmitted by eating contaminated food, by fecal-oral contact, and/or through household contact. Hepatitis A may be mild to severe; symptoms include fever, nausea, and jaundice.

Hepatitis B - Formerly called serum hepatitis, it i

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

s caused by the hepatitis B virus. About 12% of cases progress to chronic hepatitis. It is spread through shared needles, through sexual contact with infected individuals, through exposure to infected body fluids, and from mother to child. Common symptoms include abdominal pain, fatigue, fever, jaundice, and elevated liver enzymes.

Hepatitis C - is a life-threatening, disease of the liv

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

Examples of combination products may in

er, which is transmitted by exposure to blood. A particularly dangerous form of viral hepatitis, it is caused by an RNA virus. Hepatitis C can lead to serious, permanent liver damage, and in many cases, death. More than 82 percent of those who are infected will progress to chronic liver disease. It is suspected that there are, at present, more than 4.5 million people in the United States

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

that are infected with hepatitis C, and more than 200 million around the world.

What causes Hepatitis A - Hepatitis B - Hepatitis C:

Hepatitis A - is caused by a virus. The virus that causes hepatitis A is called the hepatitis A virus. Hepatitis A is spread by close personal contact with someone else who has the infection. You can also get hepatitis A by: Eating food that has been prep

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

ared by someone with hepatitis A, or by drinking water that has been contaminated by hepatitis A.

Hepatitis B - is easily spread by direct contact with the blood or body fluids of an infected person. For example, hepatitis B can be transmitted from an infected mother to her baby at birth, through unprotected sex with an infected person, by sharing needles for injecting street drugs, and

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

Combination pro

by occupational contact with blood in a health-care setting. Hepatitis B is not spread through food or water or by casual contact. People can have hepatitis B and spread the disease without knowing it. Sometimes, people who are infected with hepatitis B virus never recover fully from the infection. They carry the virus and can infect others for the rest of their lives.

Hepatitis C - is

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

one of the viruses that causes hepatitis, or inflammation of the liver. It is spread predominantly by contact with infected blood and much less from other body fluids. Risk factors for having Hepatitis C include those who have used shared needles, and those that have received a blood transfusion prior to 1991, and those who have been tattooed.

Hepatitis A - Hepatitis B - Hepatitis C - S

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

ymptoms:

Hepatitis A - A lot of people with Hepatitis A show no symptoms at all, or they go unnoticed because the symptoms are so mild. Older people are more likely to have symptoms than children. People who do not have symptoms can still spread the Hepatitis A virus. Symptoms of hepatitis A usually develop between 2 and 7 weeks after infection. The most common symptoms to appear are th

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

e following: Nausea or vomiting, Diarrhea, Fever, Rash, Fatigue, Jaundice, Dark Urine.

Hepatitis B - Like Hepatitis A, some people show no symptoms when they are infected with hepatitis B, or the symptoms may be very mild and flu-like. Any symptoms that can appear may include: Jaundice, Fever and tiredness, Diarrhea, Stomach pains, nausea and vomiting.

Hepatitis C - Again like with Hep

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

titis A and Hepatitis B, folks with Hepatitis C may show no symptoms either, but when they do, they will probably include any of the following: Mild fever, headache, muscle aches, fatigue, loss of appetite, nausea, vomiting and diarrhea. Later symptoms may include dark coffee-colored rather than dark yellow urine, clay-colored stools, abdominal pain, and jaundice.

Hepatitis A - Hepatiti

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

s B - Hepatitis C - Treatment:

Hepatitis A - There is no specific treatment for Hepatitis A. Rest is recommended during the worse phase of the disease when the symptoms are most severe. People with acute hepatitis should avoid alcohol and any substances that are toxic to the liver, including acetominophen. Fatty foods may cause vomiting because secretions from the liver are needed to di

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

Following aspects would a

gest fats. Fatty foods are best avoided during the acute phase.

Hepatitis B - Acute hepatitis B usually goes away by itself and does not require medical treatment. If very severe, symptoms such as vomiting or diarrhea may require treatment to restore fluids and electrolytes. There are no medications that can prevent acute hepatitis B from becoming chronic.

Hepatitis C - Initial treatme

dd to the challenges in developing combination products:

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

t of Hepatitis C will depend on whether the infection is in an early stage or whether it has progressed. Treatment of short-term (acute) hepatitis: Acute Hepatitis C may not be treated because symptoms are usually mild or absent, and hepatitis C is therefore often not diagnosed. By the time Hepatitis C is detected in most people, it has already progressed to long-term infection. However,

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

when acute hepatitis C is identified and treated with medications, the development of progressive or chronic infection may be prevented.

Hepatitis A - Hepatitis B - Hepatitis C - Prevention:

Hepatitis A - Transmission of the virus can be reduced by avoiding unclean food and water, thorough hand washing after using the restroom, and thorough cleansing if there is any contact with an af

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

fected person's blood, feces, or any other bodily fluid. Daycare facilities and other institutions involving close contact with people may be more susceptible to rapid transmission of Hepatitis A. Thorough hand washing and good hygenic practices before and after each diaper change, before serving food, and after using the restroom can help prevent institutional outbreaks.

Hepatitis B -

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

creening of all donated blood has reduced the likelihood of contracting hepatitis B from a blood transfusion. As an initial screen, blood donors are now required to fill out a questionnaire about their sexual and drug use activities. The blood of those who are in high-risk groups is not used. Also, serologic tests are used to screen collected blood for the hepatitis B virus. Mandatory re

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

Professional from academic institutions, pharmaceutical industries, health care indust

porting of the disease allows state health care workers to track people who have been exposed and to immunize contacts that have not yet developed the disease. Formerly, hepatitis B vaccine was made from human blood products, so it was not received well by the public. Sexual contact with a person who has acute or chronic hepatitis B should be avoided.

Hepatitis C - Is spread primarily b

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

y direct contact with human blood. Transmission through blood transfusions that are not screened for HCV infection, through the reuse of inadequately sterilized needles, syringes or other medical equipment, or through needle-sharing among drug-users, is well documented. Sexual and perinatal transmission may also occur, although less frequently. Other modes of transmission such as social,

.

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

cultural, and behavioural practices such as body piercing and tattooing, can occur if inadequately sterilized equipment is used. High risk groups include injecting drug users, recipients of unscreened blood, haemophiliacs, dialysis patients and persons with multiple sex partners.

There is a website that provides cures, facts and great information on Hepatitis A - Hepatitis B - Hepatitis

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

Companies that provide selfless information through particip

C and numerous other medical conditions, the website is called: All About Health, and can be found at this url:

http://www.rb59.com/medical-health-info

By Robert W. Benjamin

Copyright © 2007

You may publish this article in your ezine, newsletter, or on your web site as long as it is reprinted in its entirety and without modification except for formatting needs or grammar corrections

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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