E-Articles - Health and Fitness

Head lice are small, wingless parasitic insects that are found in human hairs. It also goes by the medical term pediculus humanus capitis. Alt

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

hough head lice can be annoying, it is not a health hazard and is not responsible for the spread of any disease. The Centers for Disease Contro

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

Examples of combination products may in

do not keep track of the number of head lice cases, because it is not considered a disease. This makes it hard to determine the precise number

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

of cases. But estimates by manufacturers of head lice products indicate that 12 to 25 million Americans get it each year.

A head louse (singul

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

r for lice) has 3 life cycle stages: nit, nymph and adult. A nit is a head lice egg. An adult female lays a nit at the base of a hair shaft.

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

Combination pro

his location keeps the nit warm before it hatches. Nits cannot hatch at room temperature. A nit hatches in about 1 to 2 weeks. A nit looks li

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

e a yellow, tan, or brown piece of dandruff. Unfortunately, unlike a piece of dandruff, a nit is firmly attached to the hair shaft and cannot 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

easily removed. Nits normally come in larger numbers than nymphs or adults. Nits are also bigger and easier to see. Nymphs are baby lice and

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

they become adults 7 days after hatching. An adult louse is about the size of a sesame seed. It will take on a darker color if it is found in

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

ark hair. Both nymphs and adults must feed on blood in order to survive. An adult louse can live up to 30 days on a human hair. It can surviv

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

for up to 2 days after falling off a human hair.

Determining if you have head lice can be made easier if you know where to look. Nits, nymphs

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

Following aspects would a

and adult louse are most commonly found on hairs located on the scalp, behind the ears and at the back of the neck. On rare occasions, nits, n

dd to the challenges in developing combination products:

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

mphs and adult louse can be found on the body, eyelashes, or eyebrows.

Even if you know where to look, determining if you have head lice can st

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

ll be difficult. Medical research indicates that on average, children with a head lice infestation will have no more than 10 to 20 nymphs or ad

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

lt lice. Because nymphs or adult lice are very small, low in number and able to crawl around hairs pretty quickly, finding them can be a fairly

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

difficult task. If you want to determine if a head lice infestation exists, you might want to use a magnifying glass and bright light to make t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is difficult task easier.

If there are no nymphs or adult lice, the distance of the nit from the skin can determine if a head lice infestation

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

xists. If a nit is found within a 1/4 inch from the skin, then there is a good likelihood that this person has a head lice infestation. If the

.

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

e are no nymphs or adults and the nits are more than a 1/4 inch from the skin, then this is an old infestation that can be ignored. But there h

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

Companies that provide selfless information through particip

ve been cases where a person had a few nits without actually being diagnosed as having head lice, so you should consult your doctor to make sure

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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