Advice Pool - Health and Fitness

Genital warts (also known as ano-genital warts, Condyloma, Condylomata acuminate, or venereal warts) are highly contagious. They are transmitted during sexual intercourse and caused by some strains of human papillomavirus (HPV) affecting both men and women. Genital warts do not appear unti

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

l two to four weeks after contact and sometimes months may elapse before the warts become visible. They are usually painless but may itch or produce a burning sensation. Genital warts are not life-threatening, but they can have an emotional effect, causing people to feel uncomfortable in e

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

Examples of combination products may in

isting or new relationships.

They often occur in clusters appearing as soft, moist, pink, or flesh-coloured swellings that can spread into large masses in the genital area. They can be flat. They are not visible during the early stage of development, so that at this time transmission may

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

occur without a partner being aware that they are affected. Genital warts can develop in the mouth or throat of a person who has had oral sex.

Genital warts are the most prevalent sexually transmitted infection seen at genitourinary medicine (GUM) clinics in the UK. It is estimated that a

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 many as 6 million new cases of genital warts are diagnosed in the United States each year. The condition is becoming more prevalent.

They can occur at any age but the prevalence peaks at 20-24 years. If a child develops genital warts, sexual abuse could be a possibility although it is p

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

Combination pro

ssible that the virus may have been acquired during childbirth.

Until the 19th century, genital warts were believed to be a form of syphilis or gonorrhoea but we now know that certain strains of HPV prove to be the culprits. Genital warts are highly contagious. You have a 60% chance of ge

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

ting the infection with a single sexual contact. Other common types of HPV that cause warts on the hands and the soles of the feet do not cause genital warts. Rarely, the virus is transmitted from a mother to her baby during childbirth (vertical transmission). It is a popular myth that you

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

can catch genital warts from a towel, doorknob, a toilet seat or the swimming pool. They can be caused by strains 6, 11, 30, 42, 43, 44, 45, 51, 52 and 54 of HPV; types 6 and 11 are responsible for 90% of genital warts cases. HPV types that tend to cause genital warts are not the same o

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

es as those that cause cervical cancer (types 16 and 18). Genital warts are only rarely passed on from warts affecting other parts of the body.

Genital warts are transmitted primarily by sexual intimacy, and the probability of infection increases in relation to the number of sexual partne

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

s. Smoking, oral contraceptives, multiple sex partners, and early coital age are risk factors for acquiring genital warts. The rate of growth may be more rapid during pregnancy or if a person's immune system is weakened by certain conditions including diabetes, HIV/AIDS, Hodgkin's disease,

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

chemotherapy, or taking anti-rejection drugs following an organ transplant. Non-smokers are less likely to develop genital warts than smokers.

Genital warts per se do not cause any serious long-term health problems. They are associated with cervical carcinoma as a woman can acquire multip

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

Following aspects would a

le strains of HPV. Medical providers consider any case of genital warts to be a warning of potentially pre-malignant and malignant conditions. Genital warts are a sexually transmitted disease and may, therefore, be accompanied by other sexually transmitted diseases.

No single treatment re

dd to the challenges in developing combination products:

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

imen for genital warts is better than another and no one treatment regimen is ideal for all cases. Two or more professional treatments are often required. Do not use over the counter cures for warts around the genitalia as severe irritation can occur. Genital warts can be treated by applyi

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

g the cell poison called podophyllotoxin. Before treatment commences, pregnancy should be excluded. The area should be washed and dried before application. Warticon is applied at home twice daily for three days each week for four weeks. The skin should be washed no more than four hours af

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

ter application to reduce the possibility of local irritation occuring. Cryotherapy (freeze treatment), diathermy (heat) and laser are effective. Once an individual has been infected, the virus will be carried for life, even when the warts have been completely eradicated.

Most pregnant wo

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, who have previously had genital warts, would be unlikely to have any complications or problems during pregnancy or childbirth. Unlike herpes, transmission of HPV to the baby occurs very rarely during childbirth so that genital warts are not an indication for caesarean-section unless th

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

Professional from academic institutions, pharmaceutical industries, health care indust

y are so extensive that they restrict the birth canal. Some of the medications used to treat genital warts cannot be used during pregnancy, so it is important to tell your doctor if you could be pregnant.

If you have signs of genital warts, you should avoid sexual activity until the warts

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

have been successfully treated. Condoms offer some protection against the virus, but they cannot completely prevent infection because the warts can be outside of the area protected by the condom. Spermicidal foams, creams, and jellies have not been proven to be protective. Women and men w

.

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

th more than one sexual partner, or if their partner has had more than one partner, should have regular examinations for sexually transmitted diseases, including genital warts. As with other sexually transmitted diseases, your partner must be treated as well, since an infected partner coul

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

Companies that provide selfless information through particip

easily transfer the virus back to you. Anyone with whom you've had sex should also be checked for genital warts.

The HPV vaccine, Gardasil, provides immunization against the two strains of HPV that cause 70% of cervical cancer cases, and two strains of HPV that cause 90% of genital warts

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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