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Genital Herpes- what is it?

Genital Herpes is the herpes infection of ge

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

nitals. It affects both men and women. It is caused by the HSV type2. The only way to spread this disease is

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

Examples of combination products may in

exual contact. Anybody who has genital herpes may pass it on to the partner without any knowledge. Let us see

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

how?

Genital Herpes- silent transmission

Let us take an example. Suppos

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

your partner contacted genital herpes from someone during a sexual encounter. The virus entered your partner

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

Combination pro

s body. The virus will show anytime within 20 days of getting contacted. The symptoms may be sores and bliste

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

s, fever, joint ache etc. Here comes the problem. Many times these symptoms are so insignificant that no body

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

realizes about them. The symptoms will resolve after some days. Now your partner is a silent carrier of Genit

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

l herpes. He/she may be unaware that they are carriers. During this time, if you have sexual contact with the

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

, you will catch the virus. Click here to learn more about virus type2- ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

is it" target="_blank">Genital Herpes Virus

Whenever herepes symptoms get noticed, the doctors

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

Following aspects would a

reat them with anti viral medicines. The problem of rashes and blisters gets resolved. But the virus does not

dd to the challenges in developing combination products:

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

get out of the body. It remains inside. It can cause active herpes sores again in future. Some people may not

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

get any recurrence, while some may get many.

Genital Herpes- prevention

Condoms are one wa

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

to prevent herpes. If any body part that is not covered by condom and is carrying active virus comes in cont

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

ct with you, you will sill get it. To know if anybody is a silent carrier of herpes, blood test can be carrie

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

Professional from academic institutions, pharmaceutical industries, health care indust

out by the doctor for herpes antibodies.

This article is only for informative purposes. This article is not

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

intended to be a medical advise and it is not a substitute for professional medical advice. Please consult yo

.

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

r doctor for your medical concerns. Please follow any tip given in this article only after consulting your do

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

Companies that provide selfless information through particip

tor. The author is not liable for any outcome or damage resulting from information obtained from this article

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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