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A Baby's Reflexes..

A baby is born with certain reflexes to protect them during

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

the first few weeks. These reflexes will disappear after a few weeks and be replaced w

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

Examples of combination products may in

ith voluntary movement during baby's development.

Doctors will check these reflexes to

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

ensure his central nervous system is working correctly.

Walking Reflex
If

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

you hold baby in an upright position with his feet touching the floor, his legs will se

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

Combination pro

m to be trying to walk. This reflex will last for about 3-4 weeks, and he won't actuall

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

y walk until he is around 12 months.

Crawling Reflex
Place baby on his sto

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

ach and he will take up a crawling position with his bottom in the air and his legs ben

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

t. This lasts for about two months when he will then be able to lie flat.

Search Re

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

lex
Touch baby's cheek with your finger or breast and he will turn towards the

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

source and open his mouth in search of food. This reflex will last for about 12 weeks.

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

Following aspects would a

Grasp Reflex
Place your finger in the palm of baby's hand and he will gra

dd to the challenges in developing combination products:

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

p it. This involuntary movement will persist for about 3 months.

Sucking Reflex

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

Put your (clean) finger in baby's mouth and he will suck on it. This reflex ensur

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

s he will be able to feed.

Diving Reflex
If baby is placed in water - eith

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

er during a water birth or in a swimming pool - his throat will close so that he does n

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

Professional from academic institutions, pharmaceutical industries, health care indust

t swallow the water. This means that baby will not drown if born in water, and he will

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

also be a natural swimmer. This reflex will last for about 2 months, or longer if you t

.

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

ke him swimming.

Babinski's Reflex
Stroke the sole of baby's foot and his

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

Companies that provide selfless information through particip

big toe will curl up and the other toes will spread out. This lasts for about two years

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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