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Scabies is an itchy skin condition caused by the microscopic mite Sarcoptes scabei . The word scabies comes from the Latin word for "scratch" (scabere). Mites are small eight-legged parasites

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

(in contrast to insects, which have six legs). They are tiny, just 1/3 millimeter long, and burrow into the skin to produce intense itching which tends to be worse at night. The mites which ca

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

Examples of combination products may in

se scabies are not visible with the naked eye but can be seen with a magnifying glass or microscope.

Scabies can affect people of any age but is most common in children and young adults. It i

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

highly contagious and is spread by close physical contact, especially in overcrowded living conditions. There are sometimes outbreaks in schools and residential or nursing homes. It can also

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

e passed on by sexual contact. The elderly and people who do not have a fully functioning immune system are more likely to have crusted scabies . This is a highly contagious condition in which

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

Combination pro

the skin thickens, forming a crust, and rather than having the usual amount of female mites (around 12), a person with crusted scabies can have an infestation of thousands. Crusted scabies 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

transmitted by physical contact and can also be transmitted via bedding, towels, clothes, and upholstery.

Scabies is a transmissible ectoparasite skin infection characterized by superficial b

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

rrows, intense pruritus and secondary infection . It is common all over the world, and it affects people of all races and social classes. Scabies is a very itchy skin condition caused by tiny

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

ites that burrow into the outer layers of the skin.

In adults, the most common sites are between the fingers and on the wrists, although infection may manifest in elderly people as a diffuse

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

truncal eruption. In infants and children, the face, scalp, palms, and soles are also often affected. Infection with the scabies mite causes discomfort and intense itching of the skin, particu

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

arly at night, with irritating papular or vesicular eruptions. The discomfort and itching can be especially debilitating among immunocompromised people, such as those with HIV/AIDS.

Causes of

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

Following aspects would a

Scabies

Scabies is caused by a mite (Sarcoptes scabiei) which burrows under the skin, but the rash and itch are much more widespread than the location of the mites. Scabies is passed on from

dd to the challenges in developing combination products:

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

ne person to another through intimate contact between bed fellows, infected bedding and clothes, by sharing a bed or from children who hold hands while playing. The mite can live on the discar

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

ded clothes for a couple of days. After contact, it takes about 6 weeks for the itching to start.

The itching is more severe at night. Soon a rash appears on the body this rash is not seen on

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

the face and is most prominent on the hands, the waist, the abdomen and on the genitalia. Scabies is also caused by using the infected bedclothes and undergarments, but usually people do not g

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

t infected though mode as it is a very uncommon mode.

Symptoms of Scabies

1. Sores caused by scratching

2. Pimple-like irritations or a rash

3. Intense itching, especially at night

Treatm

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt of Scabies

Skin lotions containing permethrin, lindane or crotamiton are available through a physician's prescription for the treatment of scabies. All are applied to the whole body except

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

the head and neck, and the whole family should be treated at the same time.

The treatment of choice at the moment is Permethrin, in view of its relative safety, ease of application, and as i

.

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

tends not to irritate the skin. This should be left on for at least eight hours. This may be used for the head and necks of children less than two years old. Benzyl benzoate emulsion. This is

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

Companies that provide selfless information through particip

washed off after twenty four hours, and repeated two or three times. In infants or young children it is wise to dilute in two or three times as much water, as this helps reduce skin irritation

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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