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Advice Pool - Genital Herpes
Genital herpes is one of the most prevalent sexually transmitted disease (STD). A sexually
transmitted disease is a disease that you g
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
et by having sex with someone who already has the disease. Genital herpes is usually caused by the herpes simplex virus type 2 (known as HSV-2)
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
. The disease is usually transmitted by sexual intercourse, with the virus passing from the infected partner via the skin, vagina, penis, or an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s. Once you are infected, the virus stays in your body for life. You can give herpes to another person if you have sex when your herpes virus i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s active. HSV remains in certain nerve cells of the body forever, and can produce symptoms off and on in some infected people.
Genital Herp
Genital Herp
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s is spread through direct contact. So, a genital herpes infection will stay in the area it originated unless transferred elsewhere via dir
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
ect contact or skin-to-skin transference. Herpes won't just show up on its own somewhere else on the body. Because herpes is spread through dir
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
ct contact, it is important to avoid contact with infected areas. If a herpes infection is not localized, further complications may occur. Herp
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
es is equally common in males and females.
HSV-1 can cause genital herpes, but it more commonly causes infections of the mouth and lips, so-
HSV-1 can cause genital herpes, but it more commonly causes infections of the mouth and lips, so-
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
alled "fever blisters." HSV-1 infection of the genitals can be caused by
oral-genital or genital-genital contact with a person who has HSV-1
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
infection. Genital
HSV-1 outbreaks recur less regularly than genital HSV-2 outbreaks.
Most of the people who are infected with HSV-2 have
Most of the people who are infected with HSV-2 have
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
no symptoms of disease or they do not recognize their symptoms. Only about one third of people who first become infected with HSV-2 have s
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
mptoms. These symptoms often include fever, headache, genital pain, genital discharge, and blisters. Even if you have no symptoms, genital herp
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
es can be diagnosed by testing your blood for an antibody to HSV-2. When signs do occur, they typically appear as one or more blisters on or ar
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
und the genitals or rectum. The blisters break, leaving tender ulcers (sores) that may take two to four weeks to heal the first time they occur
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
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
.
Typically, another outbreak can appear weeks or months after the first, but it almost always is less severe and shorter than the first epi
Typically, another outbreak can appear weeks or months after the first, but it almost always is less severe and shorter than the first epi
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ode. Although the infection can stay
in the body indefinitely, the number of outbreaks tends to go down over a period of years.
Once the vi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rus infects you, it moves from the skin or membranes around the genitals to the
central nervous system, where it remains for life. The virus
.
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
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
an “wake up” or reactivate
to cause a recurrence of the disease. When reactivation occurs, the virus travels down the
nerves to the skin. I
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t may cause blisters, genital itching, tenderness, burning, tingling,
or redness, but it usually just makes copies of itself with no symptoms
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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