E-Articles - Health and Fitness

Childbirth can be a stressful time and for some women it can result in a temporary hair loss condition called postpartum alopecia (also known as postnatal alopecia). T

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

he condition usually starts around two to three months after childbirth, gradually worsening for up to three months then recovering over the next three months until ha

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

Examples of combination products may in

r starts to re-grow. Postpartum alopecia is characterized as a general thinning (also known as diffuse thinning) over the whole scalp. This is unlike male pattern hair

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

loss where the hairline recedes and a completely bald patch appears on the top of the scalp. Postpartum Alopecia can affect up to 90% of all mothers and the extent of

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

hair loss can vary considerably from mild to excessive shedding.

Why does it occur?

The exact cause of postpartum alopecia is still not fully understood but it is li

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

Combination pro

nked to the hormonal changes that occur during childbirth. During pregnancy there are increased levels of estrogen in the body which keeps the hair in the anagen growi

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

g phase resulting in temporarily thicker hair. After childbirth a withdrawal of estrogen switches off the extended growing phase and switches the hair to the catagen s

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

hedding phase resulting in the sudden excessive hair loss. It has been suggested that modern lifestyles and poor nutrition are a major factor for postpartum alopecia,

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

ut research has shown that these factors do not play a part in this condition.

Can it be treated?

Since postpartum alopecia is a temporary condition where the hair f

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

ully recovers there are few effective treatments available. You can consult with you local GP for advice but you will probably be advised that there is nothing to worr

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

about due to it being part of the natural postpartum process. The best that can be done is to try not to exacerbate the condition so that no more hair loss than neces

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

Following aspects would a

ary occurs. To help maintain your hair during this period you should try and avoid hair styles with plaits, pigtails, braids and using tight hair rollers that tend to

dd to the challenges in developing combination products:

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

pull the hair. Also avoid using hot blow dryers and heated hair strengtheners as these can also put excessive stress on the hair. After washing always try to pat the h

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

ir dry with a good quality bath towel, hair is always more fragile when wet so try not to rub the hair vigorously.

Eating a healthy diet that includes fresh fruit and

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

vegetables can also play an important part in trying to maintain the hair. Fruit and vegetables contain flavonoids which are thought to encourage stronger hair growth

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

by strengthening the small blood vessels supplying the hair follicles. Diet supplements are also known to help with hair growth and these can be used to help treat pos

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

Professional from academic institutions, pharmaceutical industries, health care indust

tpartum alopecia. The most effective vitamin supplements are Biotin, Vitamin B complex, Vitamin C, Vitamin E, and Zinc and these are readily available in multivitamin

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

apsules. Finally there are a range of hair loss shampoos that may help to reduce hair loss in some cases but these are not generally guaranteed to help with postpartum

.

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

alopecia.

The most important thing to remember about postpartum alopecia

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

Companies that provide selfless information through particip

is try not to worry too much, it is only a temporary condition and it will eventually stop.

Please visit our web site for more information about the causes of alopeci

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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