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One of the things you will probably notice about your newborn is that his proportions don’t seem quite right. His head will seem

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

large in comparison to the rest of his body while his abdomen will seem very rounded – this is due to muscle weakness. His arms a

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

Examples of combination products may in

nd legs on the other hand may appear to be very skinny.

Head
A newborn baby’s head is roughly one quarter of his entire len

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

th. An adults head is about one eighth of his length so it therefore not surprising that newborn babies seem to have large heads

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

– they do. The head will probably not be perfectly round either. This is due to the fact that the bones in the head have to move

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

Combination pro

ver each other during the birth process to allow the head to fit down the birth canal. But don’t worry as this will not affect hi

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 brain and the shape of the head will soon go back to normal.

Skin
Some babies have a white greasy substance which can cov

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

r some or all of their heads and bodies when they are born. This is called vernix. Sometimes the hospital staff remove this strai

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

ght away but other times it is left to absorb into the skin naturally over a couple of days.

Dry and peeling skin is also common

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

in newborns but this soon goes away. Another thing you may notice are tiny white spots on the face. These are called milia and re

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

sult from blocked sweat glands. Don’t try and squeeze these as, again, they will soon clear up.

Birthmarks
Sometimes a baby

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

Following aspects would a

has small red marks on the skin. These are most likely to be seen on the forehead or back of the neck. They are due to enlarged

dd to the challenges in developing combination products:

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

lood vessels near the skin’s surface and are nothing to worry about. They usually disappear sometime between six and eighteen mon

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

ths.

Jaundice
It is not unusual for a baby to become jaundiced in the first few days after birth. When a baby is born he ha

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

a high level of primitive red cells and when these get broken down one of the components, a yellow pigment called bilirubin, inc

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

reases in the blood. This causes a yellow discoloration to the skin and whites of the eyes but in most cases it disappears in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

first week or so. Occasionally a baby may need special light treatment to bring the bilirubin levels down but this is not normall

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

y a cause for concern.

Eyes
Babies sometimes look as if they have swollen eyes. This occurs because of the pressure applied

.

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

during birth but the puffiness will subside after a few days. Another interesting thing about babies is that they are unable to a

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

Companies that provide selfless information through particip

ctually shed tears until they are about four or five months old. Surprising really given the amount of time they can spend crying

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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