E-Articles - Health and Fitness

Herpes Simplex virus comes from the Herpes Virus Family, called Herpesviridae of which two basic strains, notably HSV-1 & HSV-2 causes the infection. These ar

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 also known as Human Herpes Virus-1 and Human Herpes Virus – 2 (HHV-1 & HHV-2). The infections are characterized by painful blisters filled with translucent

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

Examples of combination products may in

fluids that appear on the skin or mucous membranes like the mouth or lips or on the genitals. There is nothing simple either about the HSV-1 or HSV-2 exceptin

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 they prefer to become lifelong partners of the host on whose nerve cells they are permanently engrossed. From the outside, these blisters resemble those

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

seen in chickenpox, the handiwork of another subfamily, VZV known as Herpes Virus-3 or HHV-3.

The infection may start with kissing (direct contact with lips

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

Combination pro

or through sexual intercourse (genital contact) when HSV sores are present or immediately before they appear, i.e. the Shedding stage. However, after the ini

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

tial or primary stage of the infection, the virus goes into hibernation, remaining dormant within the cell bodies of nerves, innervating the area of original

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

utbreak. After sometime the reactivation starts, when the virus is transported outwardly through the cell’s axon to the skin. And that’s when the blisters are

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

seen. Though the infection is not fatal to adults, but yet if they are present during childbirth may lead to severe complications and even the sad death of 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

e infant.

The primary symptoms of herpes simplex is burning, tingling or itching sensations near the edges of the lips or nose. This is known as the Prodroma

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

l stage. Thereafter, small, reddened spots develop in the irritated areas. And then comes the chickenpox-like blisters that are filled with fluid that often r

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

Following aspects would a

upture, releasing a sticky serum-like fluid that rapidly crusts.

The strapping tendency of the virus to remain dormant within the nerve cells for indefinite

dd to the challenges in developing combination products:

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

eriods gives it the characteristics of chronic nature. To begin with, none of the known antibiotics have any effect on viruses that come and go on their own a

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

nd secondly, it becomes extremely difficult to dislodge them from the nerve cells where they are permanently lodged. However, the initial outbreaks after the

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

xposure to HSV are more severe, compared to later episodes, since by then the body gets a chance to produce its own antibodies. Beware! The first outbreak oft

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

en carries the risk of developing meningitis.

When an HSV infection appears on the lips in the form of a blister or sore, it is commonly called a “cold sore”

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

Professional from academic institutions, pharmaceutical industries, health care indust

or “fever blister”. However, it should never be mixed up with ‘canker sore’ because canker sores are not caused by the HSV virus.

Yes, it is. Especially when

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

the carrier is producing and/or releasing, i.e. ‘shedding’ during an outbreak. Besides, like contact dermatisis, the disease can spread by physical contact d

.

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

ring outbreaks. The normal human tendency of touching a cold sore and repeating the procedure on other spots on the face or neck may trigger further outbreaks

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

Companies that provide selfless information through particip

. Touching an eye after the finger is wet with the fluid coming out of an open sore is extremely dangerous as it may affect the cornea and may cause blindness

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-article.org.ua/article/264281/e-article-Cold-Sores-and-Herpes-Simplex-Diagnosis.html">Cold Sores and Herpes Simplex Diagnosis</a>

BB link (for phorums):
[url=http://www.e-article.org.ua/article/264281/e-article-Cold-Sores-and-Herpes-Simplex-Diagnosis.html]Cold Sores and Herpes Simplex Diagnosis[/url]

Only the strongest resumes actually get past the initial 30 second screening. The national average for resumes received for each IT position advertised is 300 and increasing.

Strategies for stop skin wrinkles. Find out what you can do to prevent those fine lines from appearing

Tags

Links

E-Articles - Cold Sores and Herpes Simplex Diagnosis

Related Articles: